Creating and maintaining nonconformance records play a more significant role in quality management than enterprises think. NC record generally comprises the quality problems, the root cause, preventive measures, and corrective measures implemented to resolve it. Maintaining Nonconformance records is even recommended as best-practice to meet regulatory compliance.

What Information Does a Nonconformance Record Generally Contain?

A non-conformance record generally includes the following information:

• The main reason behind filing a non-conformance (or, what exactly went wrong)
• What led to the non-conformance?
• Is there a possibility to prevent the reoccurrence of the non-conformance reported?
• What were the immediate actions taken to resolve non-conformance?

When should you consider filing a non-conformance report?

Based on the industry-focus, there could be multiple scenarios that require you to report a non-conformance. For example – if you are in the electronics and appliances industry and the appliance is not performing the intended function it is designed for, you can file a non-conformance report. Similarly, if you are in the construction industry and work built doesn’t meet the approved specifications, it calls for non-conformance reporting. However, not matching the specific requirements of a customer cannot be filed as non-conformance. Every individual may have their needs and preferences.

Who can file a non-conformance?

The project head primarily issues a non-conformance report. The report shall contain all the occurrences along with their objective evidence. It will support the claim you want to make. The detailed information shall also be mentioned with conditions for reporting and resolution whenever the issues get resolved. The non-conformance reports can also be treated as excellent training tools for the quality managers to train their team to prevent similar situations from reoccurrence.

What can be the possible consequences of reporting non-conformances?

While reporting non-conformances help you eliminate inconsistencies from the system, they can invite certain troubles too. Non-conformances generally demonstrate your inability to manage product and process quality issues. The financial institutions consider them as a red flag, and you can expect financial troubles. Nonconformance records involves a lot of paperwork, including the information, specifications, corrective and preventive actions, procedures.

What are the next steps after non-conformance reporting?

Once a non-conformance is reported and files, you must act proactively to identify the sufficient resolution. It will require you to;

• Meet the person who has reported the non-conformance to understand the problem in a detailed manner.
• Initiate a CAPA immediately to perform inspection and investigation, and identify the root cause.
• Develop and implement the best action plan to resolve the quality issue effectively and efficiently.
• Notify the team members and seek approval from the top management for the action plan(s) (if required).
• Document all the details in the right order to prevent any compliance, audit, or inspection failure.

How Nonconformance Reporting Contribute to Quality Management?

Nonconformance reporting makes a critical contribution to Quality Management by highlighting the key areas that need improvements. After all, a product’s quality, reliability, and safety depend on its conformance and compliance with internal and external specifications.

What’s the Role of Nonconformance Management Software?

The advent of technological solutions like next-generation nonconformance management software has become quite simple and straightforward to manage non-conformance reporting.

The powerful and secure Nonconformance Management Software like Qualityze streamlines your defect and deviation management processes by providing closed-loop workflows that document, verify, disposition, and investigate product and process non-conformances, noncompliance, and deviations.

What are the core benefits of nonconformance management software?

An advanced nonconformance management software can drive multiple benefits for your organization, such as:

1. Reducing the number of Nonconformance occurrences

Once a non-conformance is identified and reported, you can immediately kick-start the resolution process. It will also help you identify the preventive measures and action plans to prevent the issue from reoccurrence. It will save you the administrative time and efforts to rework on or resolve the same problem again, allowing you to save money and resources on repetitive tasks.

A nonconformance management software helps you record non-conformance and the resolution activity and objective evidence so you can utilize them as preventive action against similar issues in the future. The software automatically documents the detailed sequence of activities so that auditors’ or the regulatory authorities can instantly trace any NC events at the desired time.

2. Minimizing the costly impact of non-conformances

Nonconformance highlights the quality issues, but it comes with several other issues, including its costly impact on overall production, manufacturing, and operational processes. It can cost an organization a fortune in terms of brand reputation, overhead expenses, and resources.

With the nonconformance management software, you can significantly reduce the costly impact of the non-conformances. You can gain better control and confidence in managing quality issues without impacting the overall production cycle. Most importantly, you can protect the brand reputation by encouraging sustainable best-practice in your organization. Would you still continue with the traditional nonconformance management system that holds you back from gaining a competitive edge?

3. Improving product/service quality

Every time a non-conformance is identified, it introduces an opportunity for the organization to improve their product or service quality. It will demonstrate your commitment to quality best practices, including continuous improvements, even if they are minor ones. It instills more trust and confidence in your customers that you provide them with nothing but quality.

A nonconformance management software often helps enterprises to foster a culture of continuous improvements by integrating with existing quality systems to create a closed-loop quality system and ensure sufficient resolution every time. Quality improvements work wonders to retain your customers and create a loyal customer base.

4. Increasing customer satisfaction

As we have already discussed above, non-conformances help improve product and service quality, which is imperative to achieve customer satisfaction. Higher will be the quality of products or services you deliver; higher will be the level of customer satisfaction. And, you are likely to receive lesser customer complaints.

The nonconformance management software helps track the source of non-conformance reporting so that you can quickly respond to your customers with effective resolutions, mainly if the non-conformance is recorded through a customer complaint or feedback. Regardless of the source, the software accelerates the nonconformance management processes to ensure customers’ quality products and services on time.

5. Ensuring efficient utilization of resources

Since a non-conformance enables enterprises to figure out what went wrong, they can plan more efficient utilization of the available resources. You can miss on an aspect or two with traditional nonconformance management solutions. On the other side, the advanced, cloud-based software solution allows you to perform timely analysis and plan your activities accordingly, ensuring proper utilization of the resources.

The nonconformance management software reduces the wastage of resources by keeping track of their utilization in different phases of the production cycle while keeping you informed on resource inventory. The software comes with alerts and notifications capability that automatically notifies the quality teams whenever the quantity of raw materials reaches below threshold quantity.

6. Improving overall QMS performance

The most critical aspect of automating the non-conformance processes is improving your quality management system’s overall performance. With the nonconformance management system software, it becomes even less time-consuming to identify, manage, and resolve the quality issues while increasing the existing quality management system’s effectiveness.

It makes more sense for enterprises to invest in a powerful nonconformance management software that can help them take a holistic approach to quality management, identifying and eliminating all the quality issues. It will be even more beneficial to implement a configurable nonconformance management solution like Qualityze EQMS Suite to personalize the workflows and dashboards while ensuring maximum productivity.

Built on the most reliable and secure cloud platform, i.e., Salesforce.com, Qualityze ensures greater scalability, flexibility, and accessibility to manage your nonconformance records.

If you wish to know more about how Qualityze works or want to request a free demo, get in touch with our customer success team on 1-877-207-8616 or write us at info@qualityze.com, and we will be right there for you.

Medical care delivery has gone through remarkable changes in the previous decade. In the last five to 10 years, medical services’ digitization has quickened dramatically because of inventive government strategies, changes in customer inclinations, a flood of funding, a developing number of computerized wellbeing business people, and proceeded with ventures by industry occupants.

The COVID-19 emergency has featured a portion of our medical services framework’s difficulties and introduced unique chances for the U.S. medical services framework to develop progressively. No matter how you look at it, we have seen medical services suppliers receive telehealth at an uncommon rate. While the last section of COVID-19’s effect on developing our medical services delivery framework is a long way from being composed, we might want to feature nine significant consideration delivery patterns quickened by COVID-19. Virtual medical care delivery is turning into an absolute necessity. The split between physical and computerized care is obscuring.

1. Virtual-first essential consideration became the dominant focal point during COVID-19, and the progress is digging in for the long haul.

Tele-medicine (or telehealth) is not a novel idea. (See the set of experiences.) Yet appropriation was delayed for the two patients and suppliers in the early years. The COVID-19 emergency has introduced extraordinary changes and made virtual wellbeing more standard. During the beginning of COVID-19, various essential consideration suppliers across the U.S. had to close down their actual offices. Thus, because of this unexpected stun, numerous of them forcefully embraced and turned out telehealth. Over time and again, essential consideration gatherings, for example, Iora Health, changed practically over to a virtual setting.

2. Specialty consideration will be progressively virtual, improving access and reasonableness. Infection centered arrangements will prosper, with full-stack contributions taking action accordingly.

Like essential consideration, a considerable bit of strength care has likewise moved to virtual delivery during the COVID-19 pandemic. Be that as it may, the normal lastingness of these virtual models will shift by strength. Toward one side of the range, there are strategy based fortes that can’t exist exclusively carefully. For example, numerous strategies in forte’s like ophthalmology and muscular health have been deferred because of a temporary restriction on elective medical procedures during the long early stretches of COVID-19.

These surgeries will return in the post-pandemic world. Keeping in mind that we don’t envision techniques being done for all intents and purposes, we predict a move towards progressively virtual preoperative and postoperative counsels. On the opposite finish of the range, we saw a quickened development of individual strengths or subspecialties into the virtual world.

3. Care will progressively be conveyed non-concurrently, with most suppliers’ quiet cooperation, including a mix of simultaneous and offbeat correspondence.

Across essential consideration and claim to fame care, we see suppliers starting to utilize an expanding blend of coordinated and non-concurrent delivery. A few sorts of non-concurrent care (e.g., sent X-beams or MRIs to be deciphered by a radiologist) are grounded. In any case, with the move towards more virtual consideration, different sorts of offbeat correspondence, for example, text and media messages, are expanding in use, both for patients to talk with their doctors and for doctors to speak with different trained professionals.

Offbeat consideration delivery intensifies telemedicine’s advantages and builds patients’ admittance to ease, high-esteem care. For example, a patient requiring non-emanant care for a skin rash would now be able to send a photograph to her essential consideration supplier. Rather than driving to the specialist’s office, investing energy in the sitting area, and just getting a couple of moments with the doctor, the patient would now be able to approach their day at home and make the proper strides when the supplier answers non-concurrently.

4. As far off working turns out to be more pervasive, business wellbeing contributions will turn out to be progressively virtual and home-driven

As per a PWC Health Research Institute study, 38% of giant managers offered an on-location wellbeing facility in 2019, up from 27% in 2014. Similarly, as these numbers are rising, the COVID-19 pandemic has made numerous organizations work with a fundamentally alien labor force. Even though telecommuting may turn out to be essential for the new ordinary, representatives will, in any case, anticipate virtually open and moderate consideration from bosses.

Medical services are not, at this point saw uniquely as a worker advantage. It’s currently a need for keeping a substantial labor force. With a massive level of bosses accepting liberal work-from-home approaches, admittance to medical services for conveyed labor forces is basic. This outlook move has quickened interest for essential virtual consideration. The premium in our telemedicine arrangement from managers has flooded by over 500% since the start of the flare-up in March.

5. Healthcare suppliers will grow the utilization of AI-based emergency devices to guide patients to a suitable site of care in a profoundly productive way.

In the wake of the pandemic, numerous unmistakable emergency clinic frameworks utilize virtual experiences to give more secure and reasonable consideration. For example, at the University of Pennsylvania Health System, telehealth is being used no matter how you look at it – to comprehend a patient’s indications and inform them whether they need to visit the ER, lessen ICU communication, and give treatment via telephone. Frameworks and government offices have quickly embraced AI indication checkers (e.g., GYANT, Ada, Babylon, and Buoy Health) to improve the tolerant experience and deal with expanded volume savvy way.

6. Healthcare for provincial populaces will be more virtual to guarantee the openness of administrations.

Giving medical services in country zones is trying on numerous measurements – enormous old populaces with various comorbid conditions, multiple uninsured patients, and absence of subject matter experts. Numerous suppliers now work at a misfortune, which has developed during the pandemic when elective methodology (which ordinarily make up a portion of an emergency clinic’s income) were dropped or postponed. As we anticipate the job that telehealth will play in essential consideration in country zones, we accept the appropriation of virtual wellbeing will be additionally quickened by creative subsidizing models (e.g., CHART) from the Centers for Medicare and Medicaid Services (CMS) Innovation Center.

7. Remote patient checking (RPM) will be a vital piece of patient consideration going ahead.

With medical services offices arriving at the limit, patients dreading contracting disease from entering a specialist’s office, and with high-hazard patients expecting to avoid others, COVID-19 has everybody contemplating the fate of care delivery in the home. Although giving consideration eliminates the human touch from medication, it likewise empowers a doctor to see a patient’s home climate and possibly find factors influencing a patient’s wellbeing that may not be clear while inspecting the patient in the workplace.

Preceding COVID-19, CMS extended RPM administrations’ repayment in its last guideline on Chronic Care Remote Physiologic Monitoring in November 2019. Expanded reception of significant worth based consideration, and suppliers facing the economic challenge of overseeing persistently sick patients, has prompted expanded interest in RPM arrangements. As per one investigation from 2019, 88% of suppliers studied have put or are assessing interests in RPM advancements. Indeed, even telecom monsters like Comcast are riding these tailwinds.

8. Chronic condition the board, medical clinic level emanant care, and inpatient-level consideration will progressively occur in the patient’s home

During the COVID-19 emergency stature in numerous states, we saw a mind-boggling interest for clinic beds for fundamentally sick patients, and multiple emergency clinics changed over different wards into ICUs. Because of a real or foreseen flood deprived for medical clinic beds for COVID-19 and other seriously sick patients, numerous wellbeing frameworks around the nation have quickened their endeavors to stand up medical clinic at-home (HaH) projects to give medical clinic level consideration in the patient’s home. (See: Intermountain’s Castell dispatched its HaH program Mayo delivered progressed care at-home model of care.)

9. There will be more prominent accentuation on social and segment determinants of wellbeing and what they mean for an individual’s wellbeing status.

The emergency has exhibited how wellbeing differences and danger levels for infection are affected by pay, geology, race, and different elements. Specialists have been bringing up the significance of recognizing and tending to social determinants like food or lodging weakness as a feature of a patient’s consideration plan for quite a long time, yet social spending in the U.S. is still low. Presently, with whole urban communities expecting to make strides like discovering lodging for destitute populaces, attention to social determinants of wellbeing (SDoH) is rising. We have seen associations quickly increase their endeavors in giving all-encompassing consideration to patients and aiding hazard bearing suppliers incorporate SDoH screening, coordination, and following as a component of their work processes.

The COVID-19 pandemic has expanded public familiarity with the imbalance in the U.S. medical services framework and the distinctions in medical care access and results across populace gatherings. An investigation of telemedicine cardiology care at the University of Pennsylvania found that patients who finished video visits with their suppliers “were somewhat more established, bound to be male, more averse to be Black, and had a higher middle family pay than patients who finished phone just visits.” For underestimated bunches like racial and ethnic minorities, contemplates show that suppliers’ doubt might be intensified in virtual settings because of restricted correspondence and suppliers being less aware of individual inclination.

As medical care delivery is becoming more populace explicit and customized, we anticipate that there will be a multiplication of the same public face-to-face and virtual consideration pioneers. The entirety of this will zero in on the requirements of genuinely underserved networks.

Another important thing that these trends highlight is the requirement of a cloud-based quality management system that can help healthcare organizations to manage their quality processes and an enormous amount of data with flexibility and security. The cloud-based systems can also seamlessly integrate with the evolving technology trends to provide you better control of processes, data, and product quality. One of the most reliable quality systems available is Qualiyze EQMS Suite. Want to know more about Qualityze EQMS Suite and the value it drives for your organization? Get in touch with our customer success team on 1-877-207-8616 or email us at info@qualityze.com, and we will be right there for you.

Even after being equipped with modern tools and equipment in the production unit, manufacturing businesses are concerned about reducing risks and avoiding costly production failures. It can happen due to poorly-managed processes, poorly maintained equipment and devices, periodic audits, and most important of all, flawed supplier management process – where it all begins.

Ensuring good quality output or products requires you to have the best quality raw materials and components. It is not practically feasible to check every single material, component, or part for quality. This is the reason; you need reliable suppliers for your business.

So, how you identify reliable suppliers?

Through the supplier qualification process! It is not as simple as it sounds. It requires you to document all the details related to suppliers like Supplier Name, Category, Site, Addresses, Contacts, Type, Certifications, and more. You can create your supplier onboarding questionnaire to verify whether the selected supplier meets all the criteria and requirements.

The next generation, cloud-based supplier quality management software comes with a pre-defined questionnaire that you can customize as per your internal and external specifications to streamline the supplier selection process.

Why is Supplier Quality Management Important?

Supplier quality management is imperative to manage critical functions such as managing supplier information, performance, and relationships. It enables any organization to:

• Improve Collaboration and Communication with Suppliers,
• Ensure consistent quality products,
• Strengthen business relationships,
• Deliver value to their customers,
• Gain operational excellence and competitive-edge, and much more.

Step-By-Step Approach: Makes Supplier Quality Management Successful

All enterprises need to develop a successful supplier quality management system is having a well-organized approach that includes the following steps:

1. Selecting the right supplier for your business and industry-type

Your business model and industry-type are different; so is the supplier-type for your business. You cannot just select the first supplier you find on the internet with minimum prices. Price is a thing that comes last. First and foremost is the quality of the products and services that the supplier delivers. In the online world of businesses where every other supplier promises to deliver quality, it can get daunting to pick the right one for your business.

Here’s the simple hack for it. Create a list of questions based on your business requirements to evaluate suppliers, including their market experience, clients they have worked for, location, and much more. It will make supplier selection easier for you.

2. Creating and reviewing the approved supplier list

Creating an approved supplier list helps you identify the suppliers that meet your organization’s selection and evaluation criteria. But you cannot keep it constant unless the suppliers continue to meet the requirements and pass the regular audits with flying colors. Reviewing the approved supplier list often helps you keep track of supplier performance and give them feedback, ensuring continuous improvements in the supplier quality.

Like audits, you can plan review for the approved supplier list regularly to grow and improve mutually, ensuring quality end-products for the customers without fail. It will significantly help improve your business-supplier relationship.

3. Auditing your supplier at regular intervals

If you want to stay ahead of ongoing supplier quality performance, you must have a streamlined supplier auditing process. The audits will help identify the supplier-related processes’ inconsistencies while enabling you to assess the supplier capabilities and make the supplier onboarding process easy and efficient. Planning and scheduling the supplier audits well-in-advance is preferred as best-practice to avoid any impact on the ongoing operations.

The best solution is integrated Supplier Quality Management Software that can help you efficiently manage audit criteria, schedule supplier audits, track and document results, and perform follow-up activities. It will help eliminate all the supplier defects and non-compliances quite systematically.

4. Measuring supplier performance and generating their scorecards

Measuring supplier performance is quite similar to the supplier selection process. It also requires you to have specific metrics defined for an error-free and unbiased evaluation of the suppliers associated with you for a long-time. The audits can be of great help here since they point out inconsistencies to investigate and determine the root cause. You can further generate supplier scorecards based on audit results and other performance criteria. It will ensure that you are associated with quality suppliers only who care for the business as much as you do.

With the right supplier quality management software, you can document all the supplier performance records as evidence of switching to another supplier. It demonstrates your organization’s commitment to best practices at the time of inspections and regulatory audits.

5. Sharing timely feedback with supplier for improved quality

Be it any business; constructive feedbacks help us all to improve and grow. It is equally essential for your suppliers to know what’s going well and what’s not to make necessary changes in their processes. It would be best if you will share feedbacks with suppliers at regular intervals. It will improve the quality of the product and strengthen your business relationships for the long-term.

The cloud-based supplier quality management software can help you collaborate and communicate with your suppliers quite often regarding the improvement required. You can also schedule follow-ups on the improvement activities using the advanced functionalities.

6. Tracking supplier performance for informed decision making

Keeping track of supplier performance is critical for informed decision making for your supplier onboarding process. You must have critical metrics to identify the fluctuations in supplier performance. You can also observe the patterns of downtime and uptime. It will help you make informed decisions to keep a supplier on board and provide them feedback for improvement or to end up the contract for continued poor performance over time.

Thanks to the advanced reporting and analytics feature of the supplier quality management software, it has become a lot easier and more efficient to track the supplier performance for any period and improve your decision-making ability. You can also guide your suppliers on the timeline their performance dripped all-time low so they can investigate at their level and improve accordingly.

Isn’t it an all-inclusive approach to perform the supplier quality management well? You can simplify it even more with the right Supplier Quality Management software like Qualityze that helps you track and manage the qualification process of new potential suppliers, maintain complete records of all suppliers evaluated on a centralized database, timely communication with all suppliers to provide feedbacks, manage approved supplier list (ASL), and manage supplier scorecard while seamlessly integrating with your existing ERP system.

Qualityze Supplier Quality Management enables organizations to streamline and standardize their supplier-related processes and mitigate operational challenges. Built on the Salesforce.com platform, it offers greater flexibility, security, and scalability to control and manage voluminous supplier records without any hassles.

A product’s quality starts at the supplier selection process as the suppliers play a vital role in bringing the product to the market. So, have you implemented a powerful supplier quality management system yet?

If not, the Qualityze customer success team can help. All you need to do is get in touch with us on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you. You can also request a free demo to get real-time insights into how the software works and make supplier quality management simple and straightforward.

Biotechnology quality management primarily requires streamlining, managing, and optimizing quality documents such as standard operating procedures. It helps them prevent compliance risks while increasing the overall efficiency and productivity to achieve quality goals and customer satisfaction.

Hence, they cannot just implement any EQMS. Biotech companies need a fully integrated and powerful quality management software to help them take a comprehensive approach to manage all the quality process efficiently and timely. The FDA has also released a guidance document ICH Q10 for biotechnology enterprises that reflect the best quality management system model. It includes the following set of requirements:

1. The document shall contain the commitment from top management to make use of the quality system and continuously evaluate its efficiency in achieving the quality goals. However, to ensure the proper use of a quality system also requires organizations to provide employee training.
2. The document shall be defined with all the organizational quality policies, describing the strategies and how they contribute to achieving compliance requirements. It will provide your employees with a much clearer picture of their roles, responsibilities, and KRA’s so they can actively participate in critical activities like system improvements.
3. The document shall be detailed with planning oversights – answering what, why, and how of every quality activity to the employees. It will help your employee to map the resources required for performing a task.
4. The document shall highlight how the organization will manage its resources and its application.
5. The document shall demonstrate a good communication strategy to be followed across the organization. It will give your employees the right direction at the time of need. For example – if a production issue arises, who will be reported, and what will be the next steps for immediate resolution, approvals, and much more.
6. The document shall outline the provision of the periodic reviews for the quality system to keep a check on its suitability and effectiveness, especially when you have introduced new policies or made some amendments to the existing ones.
7. The document shall include the management of outsourced materials to keep a check on the consistency of quality. A minor component change can drastically change the quality of the final product. Hence, the document shall guide the employees to communicate with suppliers and vendors often to cope with the changes efficiently without harming the product quality.

Aren’t all the requirements implying the need for an integrated enterprise quality management software that can help biotech companies to create a closed-loop quality system and manage all their quality processes efficiently?

An Integrated Enterprise Quality Management Software for Biotechnology companies brings along numerous benefits, which are categorized into three main benefits, including:

1. Internal Benefits

The internal benefits that organizations experience internally include increased efficiency, improved productivity, and reduced costs of quality. Internal benefits include:

• Consistent Operations

The QMS implementation helps biotech companies to achieve stability while ensuring operational consistency since inconsistency is the biggest enemy of a sound quality system. Inconsistent processes can negatively impact organizational efficiency and productivity. Industry research even shows that unreliable business operations and processes can affect quality product delivery.

A quality management system requires organizations to define quality policies and SOPs clearly and concisely. Following the quality, documentation reduces the nonconformances while maximizing the overall operational efficiency and productivity. You are likely to leverage many measurable benefits, including reduced process cycle times, lesser customer complaints, and improved analysis.

• Continuous Improvements

Continuous improvement is among the most fundamental principle of implementing a quality management system. With continuous improvement, an organization is likely to experience better performance, strategic and competitive advantages, and employee engagement. However, you need to train your workforce on the basic principle of PLAN, DO, CHECK, ACT to maintain the continuous improvements and leverage its benefits for the long-term.

This will improve your workforce’s ability to problem-solving and innovating effective resolutions for quality issues.

• Smooth Communication and Onboarding

In any industry, including Biotechnology, supplier communication, and onboarding is the critical process that gets overlooked more often. Implementing a comprehensive quality management system enables you to take care of every aspect of product quality right from where it all starts, i.e., the supplier processes. You can also integrate a supplier quality management system with your quality system to make the supplier communication and onboarding processes smooth.

• Improved Decision Making

A quality management system helps standardize your quality processes. It further enables you to achieve quality objectives, providing you the complete ins and outs of the quality system to make informed decisions.

An eQMS system also provides improved transparency through the processes, critical data, and information that enables organizations to eliminate the risks of non-compliance, nonconformances, and other product quality issues in real-time.

2. External Benefits

The external benefits are the ones that organizations experience in the marketplace, such as increased market share, better sales, and increased customer base. External benefits include:

• Increased Profits

A quality management system supports the organization’s profitability by reducing the totals cost of quality and limiting the expensive product recalls. An integrated quality management system enables you to plan and schedule all the critical activities such as audits, equipment calibration and maintenance, document change, and much more, resulting in expensive failures of the production cycle.

As they say, “Every penny saved is a penny earned,” it goes well with quality management for biotechnology as well as other industries.

• Improved Customer Satisfaction

One of the most prominent advantages of implementing a robust quality management solution is improved customer satisfaction since you can improve the planning process. If you strive to meet customer requirements, you will have more repeated customers, as keeping your customers happy and satisfied is critical to maintaining a loyal customer base. Also, satisfied customers tend to recommend your brand more often. Hence, focus on customer satisfaction for improved revenue and brand recognition.

3. Signalizing Benefits

The signalizing benefits generally include improved brand reputation and recognition. Signalizing benefit includes:

• Improved Brand Reputation

When all the processes are consistent and are managed well, the enterprise is likely to deliver quality products within specified timelines. Such a commitment to quality best practices and product delivery timelines will eventually help improve brand reputation. However, the enterprise must maintain a culture of quality internally to gain signalizing rewards.

Would you still continue with traditional practices and quality systems to ensure biotech products’ quality when you can take the biotechnology quality to new heights?

If you want to experience the technological difference, you must go for a powerful EQMS like Qualityze EQMS Suite for Biotechnology. It is specifically designed to enable biotech companies to achieve quality, compliance, and operational goals while providing them greater control and confidence in managing the critical documentation.

Built on the Salesforce.com platform, Qualityze ensures greater flexibility, security, and accessibility. It comes with truly amazing features to complement your quality systems, such as advanced reporting, personalized dashboards, configurable workflows, intuitive user interface, electronic signature, alerts and notifications, email approvals, tasks scheduler, and much more.

For complete product insights, book your demo right away. If you have any other questions or concerns about implementing quality management software for biotechnology, get in touch with our customer success team on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.

Industry 4.0 has enabled the chemical industry to utilize technology more smartly, saving them enough time and effort, usually wasted in production and back-office operations. The digital-first mindset helps them leverage smarter supply chains’ benefits and redefined business processes to take the quality of chemicals to new heights.

When we talk of the digital advantage for the business processes, quality management for chemicals is streamlined, and there has been a strategic growth in the industry. The advent of Industry 4.0 technologies, including the Internet of Things (IoT), artificial intelligence, advanced materials, additive manufacturing, advanced analytics, and robotics, has helped create a balance between cost and performance statistics.

The best thing about these new-age technologies is integrating with the existing business applications to provide chemical manufacturers more control over their data and recourses, ensuring their effective use. Let’s quickly look at the benefits of Industry 4.0 for the chemical industry operations:

1. Increased Productivity

Industry 4.0 is a combination of smarter technologies that enable chemical manufacturers to improve their process controls, increase visibility through the data and asset management, and accelerate their production cycles. It eventually increases organizational productivity and efficiency. Moreover, the new-age technology helps eliminate the risks related to product quality, supply chain, and operations. It significantly reduces the total costs of quality while ensuring the proper utilization of the resources.

Industry 4.0 also includes advanced analytics tools that help chemical manufacturers track trends and take a proactive approach towards quality management, minimizing downtime, nonconformances, and compliance issues.

2. Reduced Risks

As we have already discussed, Industry 4.0 can help significantly reduce risks by streamlining the quality processes and fostering a culture of continuous improvements. You can efficiently manage the supply chain and other critical in-house operations through the effective use of IoT. You can also track the ever-growing and changing customer demands with advanced analytics to improve product safety, quality and usability.

 “Sense and deal with problems in their smallest state, before they grow bigger and become fatal.” And this is what Industry 4.0 prepares you for.

3. Efficient Asset Management

Whether it is batch manufacturing or continuous manufacturing, you can attain high-quality production with smart monitoring techniques powered by IoT. The only challenge is analyzing the assets available at the different production phases and making the data available for the critical decision-making process. Industry 4.0 makes it simplified for the chemical industry, an asset-intensive industry, to continuously monitor the necessary equipment such as turbines, compressors, and extruders to identify and predict the possible failures. In simple words, Industry 4.0 makes chemical manufacturers shift from reactive maintenance to predictive maintenance quickly.

4. Improved Process Controls

Industry 4.0 technologies are evolved for smarter process management, providing operators more flexibility to check equipment readings and plant operations. With the advent of IoT and other advanced technologies, chemical manufacturers can easily collect and analyze structured and unstructured data through sensor-driven devices. They can also monitor the quality of the raw materials, differences in internal processes, and so on by keeping track of deviations and patterns.

5. Improved Supply Chain Planning

Whether it is about demand forecasting or monitoring the chemicals’ transit, the supply chain processes are diversified. They need to be planned and managed responsibly to achieve capacity optimization. With Industry 4.0 predictive analytics, chemical manufacturers can significantly improve their supply chain planning. They can keep track of the product’s location and share it with the customers, improving the business-customer relationship.

6. Better Employee Safety Management

To comply with regulatory standards, it is equally essential to ensure workforce safety in the chemical production units. Providing your employees, the sensor-equipped wearable techs will improve their productivity while reducing the risks of industrial accidents. The wearable tech will collect the data and help them detect the inconsistencies without relying on manual intervention. It will help supervisors improve the facilities for safety, health, and labor management. Therefore, Industry 4.0 is the revolutionary trend for manufacturing process management and employee safety management.

7. Smarter Management of Energy and Resources

Every manufacturing business looks forward to the initiatives that can help them reduce operational costs. Industry 4.0 facilitates effective analysis to trace the patterns of energy and resource consumption and identify the gaps. You can optimize your quality processes accordingly and fill those gaps efficiently.

8. Increased Business Growth and Revenue

Chemical manufacturers can develop new products and improve existing ones using advanced materials and specialty products. It may require them to perform high-level research and development (R&D), which Industry 4.0 technologies can simplify. The chemical companies can instantly integrate their customer feedback with the existing operations to customize the products as per individual needs. It will eventually help them develop new business models.

The question here is – Do you have a strong foundation to unleash the fullest potential of Industry 4.0? It is a very critical step that many enterprises overlook and land into troubles later.

Building a strong foundation requires enterprises to adopt new technology tools and implement new business processes. You may further need an integrated training management system to train your employees on managing the quality processes more efficiently, following the quality documentation. Therefore, to ensure a successful initiative with Industry 4.0, employees must take ownership of processes from start to finish.

A chemical manufacturer needs proper planning to connect the Industry 4.0 initiative with its existing quality objectives. They may require advanced quality management software, which includes built-in reporting and analytics capabilities, to fully leverage the potential of Industry 4.0.

Additionally, modern quality management systems are cloud driven that eliminates the need for setting up and maintaining the complex infrastructure for chemical manufacturers. Such systems seamlessly integrate with third-party applications like IoT technologies, enabling chemical manufacturers to easily capture, manage and analyze data from multiple business and customer sites. Another advantage of the cloud platform is improved visibility so that users can leverage the insights to make informed business decisions.

Also, the scalability that the cloud offers is unparalleled. The chemical manufacturers can get automatic updates to leverage new features as they grow and expand in new regions.

It would be right to say that cloud technology is a base for multiple technologies that empower Industry 4.0. So, chemical manufacturers must realize the benefits of upgrading to a cloud-based enterprise quality management software like Qualityze to leverage the maximum benefits Industry 4.0 offers.

Harnessing Salesforce.com technology strengths like Analytics, Chatter, IoT, Community Portals, AI along with our next-generation user interface, Qualityze EQMS Suite prepares its customers for competitive changes on the horizon while enabling them to solve traditional quality issues without being concerned about technology. If you want to know more about Qualityze EQMS Suite and its compatibility with the Industry 4.0 technology, get in touch with our customer success team on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.

Change management has never been an easier task for organizations but has always been a transformational journey for many. A successful change implementation requires you to put an enormous effort into bringing people and processes together and aligning them to make organizational changes faster and smoother.

Although the concept of change has always been a complicated one, it helps maintain a culture of continuous improvements in the organization. Broadly, a change management process is categorized into three steps, namely:

• Identify the need for change

The first step in the change implementation is identifying the need for change – where all the change is required and the value it can bring. With the change, you can identify risks and opportunities for the company. If the change seems really necessary, you must develop a plan for it, utilizing the realistic and SMART goal strategy. It will help you and your team understand what will be accomplished with the change and the possible timelines for it. It is the soundest strategy to make a change initiative in any organization.

Hence, identifying the need for change can help you make a planned initiative of continuous improvements.

• Aligning and preparing your team

The next step in the process of bringing your teams together and preparing them for the much-required change. Because if you implement a change suddenly, the people may not co-operate, and problems will arise. The reason is the most apparent human nature, and we prefer doing things as we have always done. Any sudden change makes us feel uncomfortable and resistant.

On the other hand, if you keep your teams informed and educate them properly about the change initiative, they will likely engage more in change-related activities. Communication can play an imperative role here, and you can reap your workforce potential to the fullest for making the change related processes a little less challenging than before.

• Implementing the change in the most productive manner

After you have determined the need for change and prepared your team for it, you are all set for the change implementation. The two crucial phases of implementation are execution and effectiveness review. You can break down the entire implementation process into stages to make things simple for everyone in the team and organization. You can also provide your teams with complete training on the implementation process, so they do it all strategically, preventing the chances of failure.

You also need to track the implementation process phase-by-phase to keep an eye on things – what’s going right? What’s not? What’s not required at all? What need’s more focus? And much more. In this way, you are likely to have a successful change implementation.

However, the traditional approach to change management may not be as efficient as you want it to be. You may encounter difficulties in aligning and preparing your team for the changes if you cannot communicate them effectively. It is the most common problem that enterprises face and face resistance to organizational transformations from the internal teams.

But you can escape this scenario by upgrading to advanced change management software that comes with the next generation features and functionalities to complement your change management process, strengthening your quality system. It will help avoid costs of poorly managed changes, including a significant decline in productivity, affecting the product delivery timelines.

How does Change Management Software help?

A Change Management Software can play a vital role in managing the critical changes that could mean huge success for a business. It relieves you from multiple time-consuming jobs on a daily basis, from making a change request to document its action plan, getting approvals to effectiveness check, and whatnot. A software can help reduce the change process cycles, increasing the overall efficiency to achieve the organizational quality objectives much faster.

With an intuitive interface, the software can also help overcome training challenges that organizations generally face with traditional change management systems. Most importantly, the organizations gain more transparency and control on the change processes to make informed decisions for their business success.

Adopting the new age technology is the best investment the modern businesses can make to gain a competitive edge and increase their market share while meeting the quality and compliance requirements without any hassles.

And the Next Steps?

Now that you have implemented the best change management system to streamline all the change-related activities and gain operational excellence. And then things began to change, but what next?

Since the change is the only constant, you will expect more changes over time – with the new tools and technologies are evolving. In between the existing processes and recent change, the criticality lies in maintaining operational excellence. It might require you to train and educate your employees on implementing a change without creating any fuss or confusion.

It is imperative to continuously monitor the ongoing processes while you are preparing for a more significant change because if, for any reason, the change doesn’t suit your business strategy or the implementation fails, you cannot afford to risk what’s already there and going pretty well. Always remember, change fosters improvement. If not, you cannot let it ruin the existing processes. It can further lead to unnecessary delays in product delivery, customer dissatisfaction, and a negative impact on your brand reputation.

Which Change Management Software Is Best?

The best change management software is the one that enables you to manage changes effectively while meeting compliance with the applicable regulatory standards like Qualityze Change Management Software.

Quality Change Management provides you a standard process to record, review, approve, and implement change. You can minimize the change cycle time and its impact on everyday operations. It provides you the flexibility to manage different types of change with consistent and repeatable workflows. Each change process has its predefined steps, where you can perform impact assessments, different record levels of reviews, approvals, and implementation activities. It ensures each change is completed with all the necessary steps to maintain a compliant change-controlled process.

Built on the most powerful and secure cloud platform, i.e., Salesforce.com, Qualityze ensures more flexibility in managing your change process cycles from anywhere across the globe. It comes with numerous advanced features like alerts and notifications, centralized database, chatter, email approval, electronic signature, and much more.

So, are you ready to standardize your organization’s change management process and ensure more transparent changes for improved consistency and regulatory compliance?

Get Qualityze today. If you have any questions about the software and what it offers, get in touch with the Qualityze Customer Success team on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.

The concept of “Quality” has been emphasized more than ever. However, it is a subjective term. Every person, Industry, and business may have their own version of definition for quality. But it generally has two standard criteria, i.e., It shall perform the intended function, and it shall be free from flaws.

The real challenge that arises with the concept of quality is achieving compliance with the applicable regulatory requirements. It implies the need for a robust quality management software that can help enterprises bring quality and compliance together. The right EQMS solution will not only help meet the company’s’ and customers’ requirements, but it will also help leverage multiple benefits, including:

1. Streamlined and controlled processes.
2. Reduced wastage of resources.
3. Lesser mistakes and product recalls.
4. Lowered costs of quality.
5. Quick and easy identification of training opportunities.
6. Improved employee engagement.
7. Smooth supplier communication and strengthened relationships.
8. Consistent results and timely product delivery.
9. Increased possibilities of growth and profits.

Bringing quality and compliance together is not easy unless you have the right tools and strategy. Let’s first look at a step-by-step guide to create a successful quality management strategy, and then we will look at the technology and tools you can utilize. The stepwise guide requires you to:

1. Define the quality objectives or requirements you want to fulfill

Having clear quality objectives and goals helps make the right strategy and align your critical processes in a more streamlined and standardized manner. It may take your time initially but will save you from many expensive failures towards the end. So, make a list of your requirements – internal, external, or compliance-related to set realistic goals for yourself as well as your quality team.

Also, if your team will have transparency through the organizational goals, they will make efforts in the right direction without wasting time on repetitive tasks. Wouldn’t it be a productivity bliss for the organization?

2. Identify the actionable steps to achieve compliance quickly.

Achieving quality gets more meaningful when your product or process meets compliance, as well. It opens up wider opportunities for business expansion in the global market. Building and maintaining a culture of quality and compliance is a long-term success strategy for any business or Industry. It also instills more confidence in customers, stakeholders, and even your employees.

The winning rule is quite simple here. Identify the actionable steps to achieve compliance while attaining quality, such as aligning processes with the industry best-practices specified in the standard requirements.

3. Keep the process cycles simple and straightforward.

When your process cycles are more spartan and straightforward, your organization’s productivity will be all time high. Your employees will not be following individual routes to make it all chaotic. Instead, they will follow a standardized workflow. It will save administrative time and efforts, helping them achieve quality goals efficiently. You can also review and refine your processes regularly when they are not complicated enough.

Processes being modified regularly, ensure continuous improvements in the organization, allowing you to gain operational excellence and a competitive edge. There are cloud-based EQMS available that comes with configurable workflows so you can align your processes in the most simplified manner possible.

4. Keep all the processes, policies, and SOPs documented

Keeping all the essential information regarding quality processes and policies such as SOPs documented is critical to achieving compliance with FDA 21 CFR Part 11. You can easily find reliable electronic document management software to keep your documents safely stored on a centralized platform that your team can instantly access. However, security is still the topmost concern. Make sure to choose the document management software with advanced security controls since you cannot risk your customers’ information.

The document management software provides you more control over critical information through features like version controls, electronic signatures, watermark, audit trail, and much more.

5. Ensure that your workforce understands their responsibilities

It is imperative to ensure that your employees have a clear understanding of their responsibilities to deliver the best quality results. You have aligned processes, documented them step-by-step, then only one step is remaining – i.e., educating and training your employees about the responsibilities they are expected to fulfill. You can utilize integrated training management system to keep your workforce trained and competent for the tasks assigned.

Training management done right; your employees feel encouraged and motivated to engage more and take ownership of the assigned tasks.

6. Define the key performance indicators clearly

It is crucial to understand what you are trying to achieve with all the processes you have set in, the resource requirement, and the expected results. Document the critical drivers so you can easily measure the performance and efficiency later. It will also help you evaluate the effectiveness of the changes implemented over time. If anything, not performing as expected, you can identify new areas of improvement and strategically move ahead to your quality goals.

The key performance indicators can help you take a holistic approach to improvements that can take product quality to new heights.

7. Evaluate the results against the key performance indicators

Defining the key performance indicators will alone not work; you must consistently evaluate the process’s results to determine the corrections required. It will further help in process optimization. You can also perform an analysis of results and outcomes to understand the core pattern of how things are working – whether there are significant improvements in overall quality, efficiency, and productivity. It also fosters smarter decision making among quality teams.

You can set and evaluate key performance indicators in the context of suppliers. You will experience a world of difference in your business relationships, wherein both parties can grow and improve mutually.

8. Take care of accountability.

Assigning accountability is also significant for the consistent review of the KPIs you have defined. You can make process owners accountable for the quality goals. The process owners will also feel motivated with such sort of ownership. When you put many people accountable, everyone will take care of quality at their end rather than believing it as one person’s responsibility.

9. Automate the regular activities with the right tools

With the advent of next-generation technology products and tools, you can automate many day-to-day tasks and achieve operational excellence. All you need to do is research for the right kind of tools for the processes running in your organization. If you are going to implement software, you must ensure that it is easy-to-use so your quality teams can quickly learn to operate it without any hassles or delays. It will reduce the training needs as well, and you will notice a significant growth in efficiency and productivity. So, have you identified the set of tools your quality team will appreciate?

10. Leverage the support of your team members

Segregate and spread the word to your team members, utilizing their bandwidth to productive use. With the tasks distributed so well and automated tools, you can achieve your quality and compliance goals quickly.

11. Measure the improvement opportunities

You must develop a process to evaluate the applicable quality standards regularly to determine the need for changes and identify significant opportunities for improvement. Once you start understanding and acting appropriately on the patterns and trends, you will stay ahead of the competition in terms of innovation—continuous improvement results in optimization of the organization.

Now that you have a step-by-step guide, you can quickly bring quality and compliance closer without any additional efforts.

One of the best EQMS software that can make it easier to achieve quality and compliance goals is Qualityze EQMS Suite. It helps meet your quality, compliance, and regulatory requirements by leveraging Industry best practices with standardized, repeatable processes through easy-to-configure predefined workflow templates.

Qualityze integrated design connects all the QMS processes for a complete solution. Want to know how?

Get in touch with our customer success team on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.

With the constant use and over time, there are chances of drift in any equipment’s performance. It can lead to measurement errors, which eventually will impact the quality of products and may even lead to catastrophic events. This is why; it is crucial to keep your equipment calibrated regularly.

But managing the calibration activities can be troublesome for enterprises since it involves multiple pieces of equipment from different company locations. If not managed properly, there will be possibilities of production downtime. It will further lead to delayed time-to-market.

The critical factor in managing equipment calibration is its frequency. If you can set the calibration frequency correctly, you are less likely to face production downtime or delays. Another critical aspect of calibration management is that “It is not one size fits all” thing. There are different types of equipment; so are their calibration requirements. Equipment calibration is done timely; you can significantly improve your equipment’s efficiency and performance.

Let’s Understand the Process of Equipment Calibration

Equipment calibration is one of the most effective ways to keep track of measurements’ accuracy and quality. The equipment measurements are generally compared with the standard values, which are accepted by the regulatory authorities. If any quality issue arises, the instrument is calibrated to provide accurate results within the acceptable limit and range.

It is even recommended in good manufacturing practices to focus on mitigating and reducing the factors that could lead to quality failures, inaccurate measurements, and nonconformances. Though all the equipment performs different functions and is calibrated differently, certain things are common, including:

• The Calibrators 

They are validated and measured using the test instruments. You can find the test equipment for different devices, including the spectrum analyzer, oscilloscope, signal generator, logic analyzer, and much more.

• The Results 

The calibration results are generally compared with the standard values.

• The Purpose

Calibration is basically conducted to minimize the measurements’ difference, if any. Once the equipment is calibrated, the instrument can measure any test samples with greater accuracy and precision.

• The Impact on Performance

Equipment calibration ensures better performance and equipment efficiency, ensuring zero compromises with the final product quality. Any equipment performs best when it is calibrated based on the manufacturers’ recommendations and compliance requirements.

Specific Factors That May Impact Equipment Calibration

Equipment calibration is directly associated with its accuracy and efficiency. It is quite common to see shifts and drifts in equipment accuracy for multiple reasons, including time. Although calibration ensures that equipment keeps performing accurately, it is equally essential to ensure that calibration processes are conducted in the right environment where no other factors can impact it. 

Yes, you heard it right. The overall environment can make or break the entire objective of the calibration process. Here are the factors that can disturb your calibration process:

• Incorrect values 

Any equipment’s calibration shall be completed as per the standard procedure defined. If you choose the incorrect values or try to go against the standard procedure, it is likely to change the way equipment works. It may lead to many operation errors. Even the new equipment comes with an in-built alert system to notify the operators every time an incorrect value or measurement tests; it may be hard for them to identify the calibrators that are using the incorrect values. Therefore, you must be extra careful with the values you use.

• Inappropriate calibrator

Using the right quality calibrator is critical for the equipment calibration. So, you must use the calibrators that are certified and are manufactured by reliable labs or manufacturers. Enterprises need to understand that calibrators’ quality can directly affect the calibration results, which could lead to more significant problems. Using calibrators that have precise tolerances and specifications are highly preferable for consistent results and performance. Make sure to choose the right calibrators designed with the exemplary formulations, tolerance, and measurement for the particular equipment that needs to be calibrated. 

• Environmental Conditions

As we have already discussed above, the environmental factors, including temperature and humidity, can significantly impact the calibrators and equipment. You must ensure that the equipment is calibrated in the environment within which they are going to operate. The minutest of the environment’s variations can result in a significant difference and fluctuations in the measurement.  

How to Prevent the Factors as Mentioned Above to Impact the Calibration Activities?

Well, the only way to prevent the factors as mentioned earlier is diagnosis.

Here’s how?

When you perform the equipment diagnosis, you can quickly identify the equipment which needs to be calibrated and the ones that don’t need to be calibrated since not every piece of equipment needs to be calibrated at the same time. In fact, you should prioritize the equipment and devices based on their role in product quality and safety. The regular diagnosis helps your team categorize the equipment calibration frequency – whether it is good to go with periodic schedules or go with on-demand calibration.

You can also utilize the predictive maintenance software to gather crucial information. The same can be analyzed and tracked for identifying the measurement differences to initiate the calibration activity timely and prevent production errors and delays. Such control of the data and measurement information allows you to perform all types of calibrations quite efficiently.

Is It Time for Adopting Paperless Calibration Procedure?

It has been decades since the calibration tasks are managed manually. The calibration software has brought a revolutionary change by making the entire process paperless and automated. With the software, you can streamline and standardize the calibration processes, schedules, ad activities while keeping your data safe and secure on a centralized platform. You can access the required information anytime from anywhere across the globe and share it with the authorized people.

Making calibration software-based has helped organizations save money and time while preventing frequent downtimes. Gone is the time when the admirative staff used to spend most of their productive time in data entry jobs. The whole process has become faster, better, and smarter.

The software-based calibration management improves the overall quality and efficiency of the calibration process while leveraging multiple other benefits, such as:

• Automated and reduced calibration process cycles.
• Efficient management of the calibration-related data.
• Centralized calibration database can be instantly accessed in all the production units, regardless of their geographical locations.
• Seamless communication and collaboration with the quality teams.
• Paperless calibration management.
• Integration with existing quality systems to gain better control of calibration activities.
• Achieving compliance with applicable regulatory standards.
• Accuracy & Efficiency 

Implementing an integrated calibration management solution like Qualityze provides a seamless experience in managing calibration activities while achieving three core things, including:

• Improved efficiency: With the next-generation calibration management solutions, the entire calibration process cycle can be simplified and streamlined, reducing production downtime. The software is fast and intuitive.
• Cost savings: With the automated software solutions, you can easily save a considerable amount of money effortlessly since it will eliminate the expenses like paper-based filing and storage systems.
• Improved quality: Calibration records are prone to errors when managed manually. The software has significantly improved the overall calibration quality.

Therefore, the best and simplest solution to manage equipment calibration is implementing the right calibration management software like Qualityze. It will completely transform the calibration process, making it faster and smarter.

Conclusion

The importance of equipment calibration cannot be underrated. It is the critical requirement for seamless production cycles and product quality. Whether scheduled or unscheduled calibrations, calibration management software are of great help to avoid any operational, production, and quality issues.

If you also want to know more about the cloud-based calibration management software and its benefits, get in touch with the Qualityze Customer Success team on 1-877-207-8616 or write us at info@qualityze.com, and we will be right there for you. 

Inspection is the most critical activity to ensure product quality. It involves measuring, examining, and testing all the aspects of product quality that can impact the product’s functionality and performance. It is significantly important for achieving customer satisfaction and maintaining brand reputation too.

To understand the core metrics of inspection management and quality, we will firstly explore different types of quality inspections.

What are Different Types of Quality Inspections?

Primarily, the quality inspections are categorized into three types, namely – Pre-production Inspection, In-line inspection, and Final inspection. The core objective is inspecting all the critical details so to ensure timely and effective resolution of the quality problems identified.

Pre-Production Inspection

As the names itself specifies, the pre-production inspections generally take care of quality of raw materials. All the raw materials are thoroughly checked to qualify for entering the production phase to prevent wastage and recalls. The pre-production inspections may include checking the weight and other dimensions of the product components and embellishments, stability factors, recovery states, pile retention, torqueing, and many more to comply with the internal as well as regulatory requirements.

In most of the scenarios, the quality issues are nothing but the result of defected raw materials. Inspections at the very beginning enables auditors and quality managers to address quality issues before the production start. It helps them avoid sudden failures that could further leads to increased overhead expenses and unnecessary delays.  

In-Line Inspection

Once the production starts, the criticality of the inspections increases. Some enterprises don’t have structured approach for in-line inspections, which might hold them back from achieving business goals in a timely manner. Regardless of the product or service you offer, it is imperative to conduct in-line inspections to identify the quality issues that could lead to catastrophic events in the later phase. For example – if a connector is not fitted correctly into a medical equipment, it may lead to functional issues.

In-line inspections are extremely important to prevent such issues. If you can identify such incidents within the production cycle, you have enough time and resources to get it fixed before delivery. But once such product gets delivered, you are likely to invite many other risks including life-risks for the user. Even a minor issue during the production cycle can invite major issues in the final stage.

Final Inspection

The final level inspection is the final opportunity for the auditors and quality managers to identify and resolve the quality issues before the product reaches to the customer. In the final inspection, products are checked against the specific requirements – be it appearance, sizing, fits, or its intended function.

Enterprises, brands, and retailers often skip the step of final inspection when the products are still in stock and there is a chance to prevent any harm to the customer. After the final production stage, the product gets released from the stockroom and it may get too late to do any correction. It further results into poor quality product delivery and can also harm your brand reputation.

Therefore, inspections are the best way to ensure the quality deliverables while allowing you to take informed decisions for business success.

Inspection Management and Quality: The Core Metrics

It is clearly evident that inspection management and quality are inter-related. It would be really helpful for enterprises to understand their core metrics to implement right practices, procedures and tools for achieving their business goals and competitive advantage.

1. Customer Satisfaction

“Your marketing plan is not as important as how you plan to invest in the happiness of your customers.”

If you have implemented right inspections practices and ensured quality of the products and services, you are likely to achieve customer satisfaction. The only thing that matters to your customer is your products/services to solve their problems as promised. If not, your support and services team will be piled up with customer complaints. You may even end up losing many customers and their trust on your brand.

The best solution could be a smart inspection management software that can help streamline and standardize the inspection processes throughout the production cycle. The software ensures that your inspectors are using the correct standard and characteristics for each product since it offers a centralized platform to manage the sample plan, sample size, acceptance threshold and related documents for each lot to be inspected. It allows you to manage the inspection process smoothly and efficiently, ensuring compliance.

2. Brand Reputation

“A brand for a company is like a reputation for a person. You earn reputation by trying to do hard things well.” – Jeff Bezos.

And inspection is all about ensuring that you are doing things well. Verifying the product quality before its release to customers can protect your brand reputation effortlessly as they say, “happy customers are best form of advertisement”.  Best practices for inspection and quality management demonstrates your brand’s commitment to quality, helping you to build a loyal customer base.

A cloud-based inspection management software helps you gain more control of product quality from anywhere across the globe, providing you a centralized platform to collaborate with your team for critical business decisions. Right and informed decisions at right time can work wonders for your brand reputation.

3. On-Time Delivery

“Time is the scarcest resource and unless it is managed nothing else can be managed.” – Peter Drucker.

So, why waste time with the traditional inspection management practices that are no longer efficient and effective? You can save the administration time for your inspection and quality management processes by utilizing a comprehensive quality management system. It will help you take a holistic approach to product and process quality management, ensuring timely deliverables to customers.

On-time product/service delivery reflects the culture of quality in an organization wherein every process is streamlined and standardized so well that there are lesser chances of unnecessary delays. It will further impact your business goals of achieving customer satisfaction and enhancing brand reputation.

So, how you are keeping up with these core metrics? Still using the traditional on-site quality and inspection management systems? if yes, you are likely to miss a lot of business opportunities. Instead, you can use the advanced cloud-based software solutions to manage your quality management and inspection management processes much more efficiently than ever.

The cloud-based software can firmly stand against the test of time while enabling you to comply with the increasing regulatory challenges and customer expectations. Needless to worry, when you have Qualityze EQMS suite to standardize your inspection management and quality management processes. It not only helps you to monitor suppliers and materials related risks for defining a suitable sampling system, but also helps to create a closed-loop quality system for seamless operations.

Conclusion:

The quality of a product depends on how effective, robust, and reliable your inspection management process is during its design and manufacturing stage. Thanks to the next-generation quality management systems like Qualityze that allows you to manage all your quality related processes right from inspection management to customer complaints’ resolution in a streamlined manner.

If you also want to standardize your quality and inspection management processes, get in touch with the Qualityze Customer Success team on 1-877-207-8616 or write us at info@qualityze.com, and we will be right there for you. We assure the smarter quality solutions for all your quality management needs.

For highly regulated industries like medical device manufacturing and life sciences, meeting compliance with FDA 21 CFR Part 11 has always been challenging. Being CFR Part 11 compliant implies that organizations follow best practices for managing the documentation and quality management processes. It is no longer possible with traditional document management systems. It even requires more administrative time, effort, space, and resources to maintain paper-based records for a longer time.

That’s why, FDA recommends organizations implement and use electronic quality records and electronic signatures in place of traditional paper-based systems to comply with FDA 21 CFR Part 11, which is way faster, better, and efficient.

Realistically, CFR Part 11 applies to pharmaceutical manufacturers, biologics developers, medical device manufacturers, biotech companies, and other FDA-regulated industries, with some specific exceptions. It requires them to implement controls for all the quality processes, including audit trails, internal audits, system validations, electronic signatures, and documentation to process the electronic data that the FDA requires them to maintain. You can utilize advanced document management software to gain more control and confidence in managing documentation quickly and compliant.

Before we move on to the discussion on the type of document management software you should choose to Comply with FDA 21 CFR Part 11, it will be sensible to understand the FDA Specific Part 11 Requirements first that require organizations to have controlled documents for:

Validation

Validation of the quality systems is critical to ensure consistency, accuracy, and reliability. In simple words, you need proper documentation to define the elements and their intended functions to validate their functionality at regular intervals of time. It may feel overwhelming otherwise.

Having controlled documents for validating eQMS reassures data security and the activities performed on it while increasing the integrity of your document management systems. The advanced document management software enables you to create error-free and consistent validation scripts that ensure all your quality teams are on the same page regarding the process or system validation while meeting compliance requirements. The software also keeps track of all the validation activities by maintaining the records on a centralized platform.

Audit Trails

If you want to meet compliance requirements for FDA 21 CFR Part 11, you must use secure, computer-generated, time-stamped audit trails. It will help you record the date and time of every entry and action, whether you created, modified, or deleted the electronic records. It would help to implement a powerful and scalable document management software that can automatically track the processes and keep them documented for audits or regulatory inspections.

Also, these audit trails should not be modifiable. It can be possible only when you use an automated system. Most importantly, system-generated records hold much more integrity than traditional paper-based records. It maintains a log of events (including change requests, revisions, and deletion) sequentially with E-Signatures on them.

Legacy Systems

There are specific systems that are critical for everyday operations in any organization, even if they are not modernized. Maintaining these systems and the relevant documentation is a real challenge since the documentation shall demonstrate the following details:

Whether the system is operational

What are the updates and changes done?

Integration and compliance details and much more.

You can utilize the new-age, integration-enabled document management software that seamlessly integrates with all the existing quality systems to control the business-critical information.

Copies of Electronic Records

In addition to maintaining an audit trail, you also need to retain the copies of electronic records to comply with FDA 21 CFR Part 11. These records should also be easily accessible. Credit to the technological advancements that have made document management much simple and straightforward. You can easily maintain and manage copies of your document records.

The document records can be easily held with compliance to the regulatory requirements.

The best solution here to manage documentation in compliance with FDA requirements is a cloud-based document management software that comes with:

Operational Controls

A sophisticated Enterprise Quality Management System allows organizations to monitor and control the quality procedures utilizing the ‘phase gating.’ It further ensures that the individuals review the controlled documents and that they meet all the relevant requirements before they sign off. The right eQMS solution will offer enterprises a readily accessible platform to access, share, and track business-critical information.

The advanced document management software comes with capabilities such as Email Notification and Approvals, real-time Collaboration, and Electronic Signatures to accelerate the document review and approval process. The review process allows organizations to ensure the adequacy of the information before publishing the same.

An eQMS also allows organizations to maintain and follow the industry best practices – be it effectiveness review task or executing a change request. In simple words, you can control all the document related activities in a compliant and standardized manner as specified in the regulatory requirements for controlled documents.

Advanced Security Controls

Data security is another essential aspect if you want to comply with FDA 21 CFR Part 11. It requires you to have proper security controls in place for your controlled documents and business-critical information. The traditional document management systems are not safe enough to store any sort of confidential information related to your business or customers. That’s where the advanced document management software has a competitive edge.

You can leverage the better data security controls with E-signature, password authentication, and role-based security that next-generation document management software offers. Would you still prefer the traditional document management systems that are more vulnerable to the security threats?

E- Signature

The requirements regarding the use of electronic signatures are clearly defined in Part 11. It says, “A digital signature is an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.”

The FDA allows and recommends electronic signatures to be used on electronic documents in place of ‘wet signatures’ on paper documents to streamline and standardize the business activities. To be compliant, the electronic records must include the printed name of the signer, the date/time it was signed, and the electronic signature’s intention.

A good Enterprise Quality Management Software provides administrators more control and visibility on the use of electronic signatures across the quality systems. The software also allows you to enable and disable electronic signature requests for different roles where signatures play a guard against fraud.

Integration Controls

Integration controls are also a critical requirement if you are looking for next-generation quality management software since a single document needs to be accessed at multiple locations for multiple reasons. Your document management software shall seamlessly integrate with all the existing quality systems to provide your QC teams more control over the documents and information being shared across the organization.

With advanced integration controls, you can create a closed-loop system to manage your quality processes and data.

Minimum Training Requirements

Part 11 clearly defines that all the system users should undergo the necessary training required to perform their assigned tasks and projects. With the cloud-based and intuitive eQMS, the users can efficiently produce, manage, and track the controlled documents with minimal assistance and training requirements. 

Suppose you are among the medical device manufacturers who wish to enter the competitive and lucrative US market. In that case, you must implement the eQMS, which is specifically designed to deal with all the regulatory challenges without any critical training requirements. It will undoubtedly transform the complicated process of document management into a simpler one.

And the truth is that it will be a worthy investment for multiple reasons because the eQMS will deal with the quality and compliance challenges and bring in the new tools and technologies to accelerate the document management processes, ensuring minimal to zero errors.

The single stop solution that meets all the requirements mentioned above to help you manage and maintain regulatory requirements for proper documentation is Qualityze Document Management Software.

Qualityze Document Management is a cloud-based, intuitive software that helps enterprises create critical documents such as SOPs, Training collaterals, and more using the standardized document type templates to ensure a consistent flow of information. It comes with configurable workflows so you can add or remove the form fields as desired.

You can also utilize its advanced security controls to enable security at the document, user, and or group level through multi-level profile-based access controls, ensuring that only authorized people can access the controlled records. It also supports watermark capability to demonstrate validity, credibility, and reliability of the printed information to meet compliance requirements for controlled documents.

Moreover, it seamlessly integrates with Change Management and Training Management to make the document, change, and training management processes much simpler and straightforward.

If you also want to establish and maintain an effective document management system to meet the compliance and business requirements, get in touch with the Qualityze Customer Success team today on 1-877-207-8616 or write to us on info@qualityze.com, and we will be right there for you.