Manufacturing Compliance – Things You Should Know

Manufacturing Compliance - Things You Should Know

You’ve most likely heard the word ‘compliance’ coasting around the workplace, yet it’s been at the front line of the workday since the very beginning on the manufacturing floor. Manufacturing compliance is fundamental for ensuring organizations fulfill the operational guidelines expected of them to keep working together and serving clients.  

Figure out how digitizing inside correspondences with your forefront labor force can keep your representatives refreshed on administrative news in a moment. As a mainstay of routine business activities, organizations should know the compliance conventions for their industry. It’s wise to have a thoroughly examined plan set up to ensure the business and its representatives are consistently on top of guideline changes.  

What is compliance in manufacturing?  

Before jumping into manufacturing, we first need to get what compliance is in any case. It’s a word that gets coasted around in many positions and considering current circumstances. Yet, it is a fundamental piece of your business activities, regardless of the industry you are in. As the term recommends, compliance is the demonstration of holding fast to an order—explicitly laws, guidelines, principles, arrangements, and moral practices. It can likewise be utilized to allude to the condition of meeting those orders, otherwise called being consistent.  

For manufacturing organizations, compliance comes in two structures: administrative compliance and corporate compliance. Organizations need to follow state, government, and worldwide laws and guidelines applicable to their tasks for organizational compliance. Conditions and industry bunches set up and implement these laws.  

For corporate compliance, organizations are liable for guaranteeing they are working legitimately while following their inside strategies and guidelines. Organizations and associations should know about what’s generally anticipated of them. They likewise should oversee what’s going on inside their organization to fulfill those assumptions (and assumptions they make themselves). Ensuring the organization is the main objective of compliance—shielding it from hazards like misrepresentation, misuse, segregation, squander, claims, monetary issues, and that’s only the tip of the iceberg.  

What are the fundamental spaces of compliance in manufacturing?  

The principal classes your manufacturing business should be worried about are as per the following:  

  • Anti-defilement  
  • Data insurance  
  • Employment law  
  • Export controls  
  • Fair contest  
  • Environment, wellbeing, and security  
  • IT wellbeing and security  
  • Product security  

Why Is Manufacturing Safety So Important?

Manufacturing security is about more than checking a couple of boxes or setting up “wellbeing first” signage. As a matter of first importance, fabricating security keeps individuals alive and safe. Assuming you and your laborers need to keep living—and on the off chance that you don’t need a super guilty conscience—you need to entirely focus on and put resources into a protected work environment.  

Manufacturing security is additionally attached to labor force efficiency: the fewer wounds and mishaps your representatives’ experience, the fewer disturbances your business faces. Third, fabricating wellbeing is a primary type of hazard on the board. Each perilous machine, conduct, and the cycle is an obligation that should be amended right away. The more dangers you have, and the more you stand by, the higher the cost you’ll pay when something turns out badly.  

Last, producing wellbeing is a legitimate necessity. To guarantee your association follows government and state laws and to ensure you don’t turn into the subject of a claim or criminal accusation, you need to make and keep a work environment liberated from dangers. Remember that manufacturing wellbeing and benefit go connected at the hip. Safe organizations perform better and stay in business longer than hazardous organizations—it’s a reality.  

Manufacturing Compliance: What Safety Rules Apply to the Industry?  

The principles above are only a modest bunch of the numerous security rules makers need to agree with. In addition, there’s a letter in order soup of administrative offices and industry standard-setting associations out there, each with their own standard sets and needs.  

There are various government laws concerning producing security. These laws are authorized by the Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC), the Food and Drug Administration (FDA), and the National Highway Traffic Safety Administration (NHTSA), among others. Contingent upon the state or states in which you work, you may likewise have to guarantee compliance with neighborhood laws that are by and large more rigid than government guidelines. OSHA State directs these laws Plans just as different parts of the public authority at state, province, and city levels. On top of all that, various global guidelines are administering the manufacturing business.  

Compliance further develops item quality and consistency.  

Government compliance guidelines can be utilized to set the bar for the nature of your items. When everybody in the organization knows the objective you should achieve, everybody will be pursuing that objective together. By remaining in compliance, your item quality will remain reliably high. Compliance can be utilized to empower your business to be the perfect example of best practices. While contenders might be leaned to compromise, you will enjoy a cutthroat benefit by keeping up with high adherence to guidelines.  

Nothing turns a company’s attention to its audit and improvement processes more rapidly than the threat of a heavy fine or an impending review. With a solid compliance program, you will be set up to survey your cycles before reviewing and making changes or discovering new regions to improve. Additionally, if your manufacturing business is agreeable by plan, you will be set up to develop changes in innovation, laws, or client assumptions. 

How Manufacturing Companies Can Create a Culture of Quality and Compliance? 

Following traditional methodologies and tools will not be a practical solution anymore. Instead, the growing challenges require companies to leap with next-generation technological solutions. 

A powerful and reliable enterprise quality management software like Qualityze EQMS can help. It enables organizations to streamline and standardize critical processes following compliance standards, preparing your quality teams for the competitive challenges. 

Qualityze helps manufacturing companies to take a proactive approach towards the risks to ensure product quality, security, and reliability. In addition, the intuitive interface and configurable workflows make quality management activities more straightforward and more accessible for the users.  

Built upon the world’s most secure and reliable platform, i.e., Salesforce.com, Qualityze enables your quality teams to manage end-to-end quality processes from anywhere around the globe. In addition, it comes with impressive in-built capabilities such as Centralized Database, Digital Signature, Dashboard, Reports, Audit Trail, Chatter, and much more. 

Related Articles: How A Centralized Database Makes a Difference?

To know more about Qualityze EQMS Suite and get a free demo scheduled, please get in touch with our customer success team today at 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.  

7 Common Compliance Issues Faced By Pharmaceutical Industry 

7 Common Compliance Issues Faced By Pharmaceutical Industry 

Do you worry about getting an FDA 483 letter

Your situation is not unique. Regulations in the pharma industry have never been more strict. According to FDA data, 3,344 observations were written to pharmaceutical firms last year. However, the best time to stay in compliance with cGMP for quality is before you feel the consequences of a failing inspection. 

The best way to ensure you don’t get a 483 is to focus on the most likely areas to cause the problem. 

Let’s look at the seven most common compliance issues and how you can handle them. 

7 Common Compliance Issues in the Pharmaceutical Industry (and How to Avoid Them) 

The US FDA releases an annual report summarizing observations from inspections by industry. The pharma industry in 2018 received 3,344 observations for 390 categories of noncompliance. Almost a third of these observations (39% of them) can be divided into just ten categories, thus illustrating the common challenges of pharmaceutical compliance. 

However, the results become even more apparent when you group the data into categories based on the top ten reasons. 

The four-and-a-half-dozen organizations received a 483-letter relating to noncompliance for creating or following procedures or problems with record-keeping. Additionally, 322 of the pharmaceutical companies had difficulty designing and implementing adequate controls, and 137 had trouble maintaining their products. 

Whenever a pharmaceutical startup or scale-up approaches market approval, it is customary to go through growing pains. A laboratory manager may discover that a batch of maintenance records was not reviewed the week before he went on vacation, for example, even though your means of doing things seem to be working. Fortunately, there is an easier way to handle an FDA inspection than simply hoping for the best. 

1. Lack of Clearly Defined Procedures and SOPs 

In a Standard Operating Procedure (SOP), clear steps are outlined for carrying out specific tasks in the workplace. Using an SOP simplifies communication and makes it easier to perform the necessary functions for the work to move forward. However, compliance issues tend to arise due to a lack of effective SOPs/Written Procedures. 

Various issues prevent creating and using SOPs, including complicated language, lack of standardization, and inadequate training. 

Related Articles: Workplace Productivity Depends on Employee’s Training and Development

2. Inadequate Maintenance Facilities 

During 2018, more than 2 percent of the FDA observations were for inadequate cleaning, sanitizing, and maintenance. Sanitizing, maintaining, and cleaning equipment and utensils appropriately must comply with the FDA Code of Federal Regulations. 

The company should clearly outline the methods for cleaning and maintaining hygienic conditions. For example: 

  • Providing clear instructions for cleaning. 
  • Indicating who is responsible. 
  • Planning your cleaning schedule. 
  • Providing the guidelines for maintaining the equipment properly. 
  • Ensuring regular inspections and protective measures for equipment. 

Additionally, it is essential to maintain cleaning activities logs and update them as often as other operational logs. 

3. Not properly utilizing data 

Real-time access to data allows companies to stay abreast of changes in compliance and improve performance. By doing this, an organization can minimize the effects of non-compliance effectively. Unfortunately, one of the key reasons that organizations cannot utilize the available data is outdated technology. 

Compiling data from legacy systems is challenging. Most legacy systems provide incorrect data, and integrating new data is a complex process. It further keeps pharma companies from compliance reporting. Organizations often lack adequate reporting systems. To solve this problem, they use manual reporting systems, but they are susceptible to error. Additionally, the long-term costs are high. Companies should prioritize compliance needs and failing to do so could have dire consequences. 

4. Inadequate laboratory control 

About 4% of all FDA observations in 2018 concerned failed laboratory controls. To maintain the laboratory data, it is necessary to monitor and maintain the laboratory controls. In addition, raw data can help determine many items, from instrument calibration to employee compliance to SOP adherence- which can prevent problems from arising. 

5. A lack of communication and collaboration 

A SOP without clarified roles and responsibilities creates ambiguity. The employee is better able to perform their duties and remain compliant with standards if they correctly understand what is expected of them. Moreover, providing compliance training at regular intervals keeps them prepared for the unforeseen challenges they may face in their tasks. It would be best if you equip them with tools so they can communicate, collaborate, and learn new skills. For example, you can utilize a next-generation training management software to manage employee training while giving them a centralized platform to communicate and collaborate. 

6. Participation among departments is low. 

Developing an SOP isn’t a linear process. You must update it to keep it current. It shouldn’t be the responsibility of one department to create and maintain these documents. To ensure that the SOPs remain relevant, departments that use them need to collaborate and update them as required. In addition to encouraging feedback, employees will offer suggestions for improvements. It will help maintain a culture of quality and continuous improvement. You may need a good Change Control Software to manage changes in processes, documents, facilities, and more. 

7. Faulty Product Review Records 

To avoid omissions, the review and investigation processes must be clearly defined. Several ways are available for organizations to become out of compliance with CFR 211.192, which include: 

  • Failure to perform a thorough log review 
  • Reviewing downtime, cleaning, and clearance logs is a must 
  • Process failures 
  • Lab workers can’t examine their records 
  • Lack of standardization 

An operational team and the quality control unit should use a single set of standards and standard operating procedures for batch record review to prevent any misunderstandings. 

It is unacceptable for a pharmaceutical company to receive a 483-letter due to its first FDA inspection. The 483 letter signifies that your organization is out of compliance, even if you have corrected the problem. The long-term costs of uncorrected quality and operational issues outweigh the cost of continuously following FDA best practices. 

The causes of noncompliance with cGMP are rarely willful. Typically, 483 observations are the result of oversights. This may be the case as the laboratory manager forgot to review maintenance records after a week on vacation. An older copy of the SOP may be used by lab employees who lost the updated document. A broken workflow or collaboration may result in noncompliance issues or simply human error. Fortunately, your quality management system can help you avoid many of these issues. 

The Qualityze Enterprise Quality Management System (eQMS) is a cloud-based eQMS built specifically for fast-growing startups and scale-ups, regardless of their industry focus.

Feel free to contact our customer success team by calling 1 877 207-8616 or by email at info@qualityze.com for more information or a free demo of Qualityze EQMS Suite. 

How to Comply with FDA 21 CFR Part 820? 

How to Comply with FDA 21 CFR Part 820?

In the world of compliance, there are a lot of stakes. Food and Drug Administration (FDA), the teacher, in this case, can provide you with the correct answers. 

It doesn’t mean that 21 CFR Part 820 will be easy to follow. There are different challenges. Companies that lead the medical device market don’t have all the knowledge—they are successful because they implement the knowledge. 

The internet is full of information. What makes a medical device company excel is its ability to grasp it all and execute, understanding the big picture (What does 21 CFR Part 820 cover? What is it for?) and the granular details (How is an approved supplier list compiled?). 

Through this in-depth and easy-to-understand guide, you will gain a comprehensive understanding of 21 CFR Part 820 as it explains the regulations step-by-step. Throughout the manual, you’ll find answers to several questions mentioned above and specific instructions on how to comply, as well as common errors manufacturers, make so that you can stay out of trouble. 

Before we dive into the details of adherence to the quality system regulation for medical devices, let’s review the basics of 21 CFR Part 820. 

A brief overview of 21 CFR 820 

Medical device manufacturers must adhere to the FDA’s (CGMP) regulations as part of their quality management system as outlined under 21 CFR Part 820. An enterprise quality management system ensures that medical device companies deliver safe, effective, and compliant products. 

To summarize, 21 CFR Part 820 regulates “every aspect of human-use devices, including their design, manufacture, packaging, labeling, storage, installation, and maintenance,” as well as their facilities and designs. 

What is the FDA’s 21 CFR PART 820 requirements for quality systems? (And how to comply with them?) 

FDA’s 21 CFR PART 820 requirements for quality systems are divided into multiple subparts, including: 

1. 21 CFR Part 820 Subpart B—Quality System Requirements 

The 21 CFR Subpart B has three primary sections. Section one discusses management responsibilities, which include creating policies, resources, performing reviews, and planning. Quality audits are covered in the second section, while compliance with regulatory requirements is dealt with in the third section.  

The only way to comply with all three sections is to have quality management software that manages quality documents, conducts regular audits so you can improve continuously, and helps train employees on compliance best practices. Furthermore, it will help you create a culture of quality where quality is everyone’s responsibility. Such a culture encourages quality teams to manage quality and compliance risks proactively. 

2. 21 CFR Part 820 Subpart C—Design Controls 

21 CFR Part 820 Subpart C includes the requirements for the design process, including – planning, designing, review, verification, validation, change management, and maintaining design history records. The most common mistake observed in the designing processes is that organizations delay creating design controls. This further keeps them from collecting the relevant data. 

To comply with the requirements of the design process, organizations should identify the pattern of critical processes and create workflows accordingly. It will help them collect the necessary data on time to further utilize for planning and decision making. A QMS can, however, allow you to configure workflows based on your business requirements. 

3. 21 CFR Part 820 Subpart D—Document Controls 

21 CFR Part 820 Subpart D relates to document controls that quality managers use to manage documents throughout the product lifecycle for medical devices. Document control includes establishing procedures for creating controlled documents, reviews, approvals, distribution, and change management. The inability to manage controlled documents can put businesses at compliance risk. 

The best escape here is an electronic document management system to simplify document control processes for you. The software will help your teams to manage documentation-related processes proactively while ensuring organization-wide distribution of the same documents on time. In addition, you can easily find a DMS that supports digital signatures for meeting compliance. 

4. 21 CFR Part 820 Subpart E—Purchasing Controls 

Controls for purchasing are discussed in 21 CFR Part 820 Subpart E. It guides about evaluating suppliers, contractors, and consultants, as well as obtaining purchasing records. The most overlooked mistake companies make is not assessing their suppliers appropriately. Subpart E outlines the requirements for supplier qualifications that need to be evaluated precisely before the onboarding process. 

Therefore, companies should take supplier quality management more seriously. They can implement Supplier Quality Management Software that helps them to streamline all the supplier-related processes, including selection, onboarding, and auditing. Using the software, you can also create and update your approved supplier list at regular intervals to ensure you are doing business with suitable suppliers. 

5. 21 CFR Part 820 Subpart F—Identification and Traceability 

A crucial part of 21 CFR 820 is Subpart F, which describes identification and traceability. In the context of identification, it means avoiding product “mistakes”; in the context of traceability, it means tracing defects back to their source. Unfortunately, medical device companies often find it challenging to create a closed-loop quality system due to decentralized and disparate systems that impact traceability. 

The best solution here is an integrated quality management solution that can help medical device companies to create a closed-loop quality system. It will help them identify and manage inconsistencies in the system efficiently. Also, the software with a centralized platform will improve traceability of the quality issues to resolve them as soon as possible. 

6. 21 CFR Part 820 Subpart G—Production and Process Controls 

The 21 CFR part 820 subpart G focuses on production and process controls. These controls include inspection, gauging, testing equipment (calibration and maintenance), and process validation. The key challenge here is creating a validated system for inspection, calibration, and maintenance processes so you can deliver the best quality products every single time. 

If creating validated processes and systems sounds like a tedious job, you must upgrade to next-generation quality management software that can help you create repeatable processes for inspection, calibration, and maintenance. It will help ensure quality at every stage of production without any hassles. To put it simply, you can standardize the production and process controls with the suitable QMS. 

Related Article: How Cloud QMS Simplifies Process Validation?

7. 21 CFR Part 820 Subpart H—Acceptance Activities 

Under part 820, subpart H, acceptance activities are described. This includes acceptance of the receiving, in-process, and completed devices, as well as the regulations for approval. The mistake that companies make here is not having a standardized inspection management system in place. A formalized system can help identify the nonconforming materials as well as material reinspection needs. 

Inspections can be very challenging to manage manually. It would be best to implement Inspection Management Software to streamline all the inspection-related processes. The software will help you generate reports quickly to identify trends and make informed decisions. Inspection management software automatically stores all the relevant information for quick future reference. 

8. 21 CFR Part 820 Subpart I—Nonconforming Product 

Part 820 of the 21 CFR relates to nonconforming products. The process includes the control of nonconforming products through review, disposition, and rework. The medical devise companies often face challenges at setting up adequate procedures to manage product and process nonconformances. It becomes important to identify nonconformances and resolve them in a timely manner. 

At this point, companies would find a nonconformance management software useful. The software will help streamline nonconformance workflow to properly contain, dispose, investigate, and resolve defects and deviations. The next generation nonconformance management system also helps meeting compliance with applicable regulatory compliance. Handling nonconformances correctly can make a world of difference for your brand reputation. 

9. 21 CFR Part 820 Subpart J—Corrective and Preventive Action (CAPA) 

In Subpart J of 21 CFR Part 820, we talk about corrective and preventive action, also known as CAPA. CAPA is a method for addressing structural flaws in the manufacturing process of medical devices. The most common issue with managing CAPA’s is categorizing events since all the quality issues cannot be dealt with as CAPA. 

For a holistic approach towards quality issues, medical device companies can use powerful CAPA management software. The software can help perform a risk assessment and analysis to identify root causes and develop an effective action plan accordingly. Using the software, you need not worry about documentation since it automatically records all the CAPA details. 

10. 21 CFR Part 820 Subpart K—Labeling and Packaging Control 

Part 820 Subpart K of the 21 CFR lays out requirements for labeling and packaging. It covers labels, inspection, storage, and operations. But, unfortunately, the most common mistake companies make is applying blanket rules for labeling the devices. And, this could lead to severe consequences, especially when a device requires sterilization. 

Companies should highlight the critical information on labels as prescribed in the FDA guidelines for proper packaging and labeling. In addition, the companies can educate and train their staff on the importance of correct labeling and packaging to avoid issues. Finally, it is essential to understand that the importance of labeling may vary from device to device. 

11. 21 CFR Part 820 Subpart L—Handling, Storage, Distribution, and Installation 

Part 820 Subpart L of the 21 CFR specifies the handling, storage, distribution, and installation of products. This includes protocols for compliant storage and distribution. The issues that arise in this area are common because of not defining the specifications clearly. Therefore, medical device companies need to define and document all the requirements to avoid conflicts later. 

The companies need to have a quality management system to store all the documents related to internal and external specifications. Software with a centralized platform can provide your quality teams easy access to all the information required, ensuring everyone is on the same page. 

12. 21 CFR Part 820 Subpart M—Records 

Specifically, the records requirements are found in 21 CFR Part 820 Subpart M. Here; you’ll find a set of general conditions, rules for quality system records, complaint files, and the frequently misunderstood device master record and device history record. It also covers the confidentiality and retention period of the documents. 

It would be best for medical device companies to have document management software that provides scalable storage and supports all the compliance-related functionalities such as digital signature, watermark, role-based access, audit trail, and much more. The software will also allow you to define the retention period of controlled documents without any hassles. 

13. 21 CFR Part 820 Subpart N—Servicing 

The 21 CFR Subpart N is concerned with device service. It includes maintaining instructions to perform and verify servicing of the devices, analyzing service reports, identifying reports that need to be filed as a complaint, and documenting all the reports. The most common mistake companies make is not maintaining enough records to verify service. 

The medical device companies can manage services-related documents, including specifications and procedures, using the right eQMS software. It will help them to perform compliance related report submissions efficiently. Also, it will help maintain consistent flow of information in and out of the organization. 

14. 21 CFR Part 820 Subpart O—Statistical Techniques 

Part 820 Subpart O of the 21 CFR covers statistics. Accordingly, manufacturers are expected to use compliant statistical techniques to determine, confirm, and maintain the processes and characteristics that are acceptable.  

Medical device companies can look for innovative techniques to manage and maintain the statistics. The new-age tools can simplify the statistic related processes. Make sure you choose the right one for your business requirements. 

From all the requirements mentioned above, it can be estimated that medical device companies need powerful enterprise quality management software that can help them manage all the critical processes in a closed-loop system. In addition, it will create a culture of quality and continuous improvement. However, it can be a little challenging to find the right solution to cater to growing business requirements. 

But we have got you covered! 

Experience Qualityze difference in managing all the quality-related challenges of medical device companies. 

To request a free demo or get more information, please get in touch with our customer success team today at 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you. 

Why is Quality Assurance Important in the Logistics Sector?

Why is Quality Assurance Important in the Logistics Sector?

Customer satisfaction is the goal of every organization striving to survive in this growing competitive environment. For this, a business needs to focus on finding new customers, retaining existing customers, and satisfying each customer with the best products or services that they seek from the company.  

Businesses should also understand that Logistics Quality Management is a critical practice for their survival and growth. Quality Assurance, Quality Control, Quality Management are all interlinked in their benefits of process improvement, productivity increase, customer satisfaction/loyalty increase, and more. 

Quality Management Software makes it easier to keep track of processes and provide measurable improvements in an organization’s overall quality of goods or services. Unfortunately, some managers do not use Quality Assurance Software because they are unaware of its importance. Instead, they get done using traditional manual methods, which are often ineffective or inefficient. 

An ISO 9001 software can help management fulfil their mission more effectively by keeping them updated on each process followed under Quality Management in Logistics. Furthermore, quality management software helps manage quality control and quality assurance. Both functions are essential for any industry, especially in the Transport and Logistics sector, where Quality Control and Quality Management can be linked together and make a huge difference. 

Role of Quality Control 

Quality control provides tangible, initial evidence that quality assurance is being followed correctly, and quality control logs help quality managers in quality management. Quality control ensures that the required standards for quality are met consistently, and you can track it all back to one place, which helps managers with informed decision-making. 

Many logistics companies had seen a significant increase in customer satisfaction and loyalty when they implemented quality management software. A few examples of such companies include: 

  1. FedEx Logistics – The Logistics Department of FedEx uses Quality Assurance methods to ensure the safety and accuracy of handling packages routed through their logistics network. 
  2. Mercedes Benz – They use Quality Assurance techniques to prepare cars for shipment after production. Quality Assurance provides many benefits to companies like Mercedes Benz, who export vehicles to other countries for business reasons and use Quality Assurance methods to protect their global reputation. In addition, these Quality Control Techniques help them in Quality Management Systems (QMS), which they implement over their Logistics Sector. 

Many Quality Management Software providers are now available online. Managers can select what best suits their needs and pay monthly or yearly depending on customized software packages required by an organization.  

Related Article: Here Are the Biggest Challenges of Logistics (And How You Can Handle Them?)

The manual procedures require managers to ensure that quality assurance policies/procedures are implemented successfully with quality control guidelines. If they fail, it won’t be long before the company sees declining market shares and increased customer complaints due to poor quality. On the contrary, quality management software ensures that quality controls are accessible, consistent, and accurate. 

One of the main benefits of quality management in the logistics sector is the efficient monitoring of quality controls. It further helps increase process efficiency, profitability, and customer satisfaction. By utilizing software against manual quality control methods, you are doing your company a favor. 

The quality control & management software helps keep everyone accountable for their roles, so each department works towards achieving improvement goals required by top management. So, you will be able to increase productivity and achieve cost reduction. In addition, you will be able to eliminate redundant processes or procedures that follow duplication in work practices. This is known as 5S Quality Control.  

Quality assurance also includes inspections, as you can reduce expenses accrued towards the inspection. In addition, integrated quality management software allows conducting quality inspections efficiently because it tracks everything, even Quality Control Documents, Quality Management Systems (QMS) related data, and Quality Assurance policies/procedures required by top management. 

Related Articles: Importance of EQMS in the Logistics Industry

By implementing the right software, you can stay ahead of your competition since you know exactly what goes through in the background of your quality control procedures. However, some managers still prefer manual methods when quality management software has proven that automated systems produce better results. The software also increases quality control over the Logistics Sector, which is a big plus for companies that have just started reaping the benefits of quality assurance or those who want to stay ahead of their competitors by keeping quality assurance standards high enough. 

Utilizing software helps assure that the data quality engineers, and auditors use is accurate, relevant, and up to date. In addition, the users can update quality standards in software required by top management daily, ensuring quality results. Quality control experts usually collect data related to operations like: 

  1. Number of Shipments Accepted and Rejected 
  2. Details of quality inspections conducted 
  3. Quality checks on incoming raw materials/components 
  4. Quality tests on finished goods 

Quality assurance policies/procedures can be documented directly into quality management software to help employees follow them as they work. The software allows quality engineers to produce quality inspection documents, Statistical Process Control (SPC) Charts, Quality Plans, Declarations of Conformity (DoC), Protocols for product testing, methods according to international standards, etc. It’s a complete package where data is collected automatically without any human intervention. You can also integrate quality management software with the existing system to leverage more control and confidence in managing your quality data, processes, and systems. 

Moreover, using automated systems like quality management software to carry out quality tasks saves your employees time since they can do more in less time, overall affecting company efficiency. This ensures that the company becomes efficient and productive because employees are given opportunities to improve their performance through Continuous Improvement activities driven by the Quality department’s continuous improvement process utilizing innovative ideas from people who have hands-on knowledge about Quality Centers, Logistics processes, and Quality Assurance.  

Quality Department’s ongoing improvement process typically improves Quality System (QMS) procedures and Quality Control Centers, constantly making Quality Inspections and Quality Assurance tasks more effective and reliable. This brings automated Quality systems close to the widely used Six Sigma Quality methodology, one of the most popular in the Quality Management segment. 

Quality Assurance procedures commonly involve: 

  1. Documenting Quality Procedures 
  2. Executing quality tests on incoming components 
  3. Inspecting Manufacturing Processes like- Production quality planning, control, monitoring, and reporting 
  4. SPC, Test Plans, etc. 

Quality Management software will help you maintain transparency because everything necessary will be kept under one roof, like managing processes, improving efficiency, and measuring performance. Once you automate all these processes, it helps you gain more accurate quality assurance reports, and quality control reports required for the smooth running of a business. In addition, new strategies for improvement can be formulated by the management and implemented with the help of a powerful Quality Management Software like Qualityze eQMS Suite. 

Conclusion: 

Quality Assurance makes quality control much more manageable and effective because it provides an entire system designed to track every step in the process to identify any flaws or loopholes immediately and perform quality control procedures about those steps that require special attention or treatment by management. Quality Assurance also ensures that risks related to compliance with government regulations such as health standards, environmental standards, etc. 

11 Essential Elements of A Quality Management System

11 Essential Elements of A Quality Management System

Although quality issues may seem insignificant, their effects on your brand reputation and relationships with customers, stakeholders, and suppliers are significant. It is therefore crucial that you prioritize quality management in your organization.  

This post will discuss the 11 steps of quality management in the business environment that will give you more confidence to achieve new excellence levels and prevent potentially dangerous mistakes. 

Quality Management System: 11 Essential Elements 

There have been countless approaches to quality management over the years. Quality management is a system that is based on concepts developed in medieval European guilds. These concepts have been refined and enhanced over the centuries. The quality management system (QMS) model has been adapted to manage eleven essential elements that constitute the framework for quality. Those elements are: 

1. Organizational Changes 

Any organization should focus on developing a culture of quality to manage changes efficiently. Whether it’s about changing policies, SOPs, processes, or facilities, there is a need for a standardized change management system that supports organizational changes without impacting ongoing operations. 

2. Employee Training and Engagement 

Businesses are most successful when they have highly skilled staff members. Also, employee training, motivation, and engagement are essential components of quality management. Therefore, make sure you use a comprehensive training management system to maintain your employees’ competency for all assigned tasks. 

3. Equipment Calibration and Maintenance 

Equipment in the production units must be calibrated and maintained regularly to ensure its safety. However, it can be daunting when you must manage calibration and maintenance activities manually. Therefore, it would be ideal for implementing calibration and maintenance management software to manage equipment-related activities efficiently. 

4. Inventory and Supplier Quality Management 

Supplier quality management is key to ensuring consistent, high-quality raw materials and supplies. Also, inventory activities must ensure that materials and supplies are stored correctly and protected from damage. For this, you can use powerful supplier quality management software that can help streamline all your supplier-related activities, including supplier qualification, selection, onboarding, audits, and much more. 

5. Process Control 

Appropriate process controls play a significant role in delivering consistent quality results. QC processes include the following in process control: 

  • Assortment/Classification 
  • Process Management 
  • Verification of the Methods Used 
  • Process Evaluation and Validation 

You can dramatically boost your internal efficiency using design control software if you struggle with process control. For validation, make sure you choose a software with digital signature capability. It will help meeting compliance as well.  

6. Documents and Records 

The concept of document management is fundamentally about managing information, and these two categories overlap significantly. Documents like standard operating procedures (SOPs) create uniformity for each process. Documents should be kept up-to-date, accurate, and securely stored on a centralized platform. Identifying the right document management software should be a top priority for any company looking to grow. 

A business produces a great deal of information, including QC test results, maintenance reports, and more. Therefore, they must ensure that all the information can only be accessed by those with the appropriate privileges, such as quality managers. For this, you can easily find cloud-based document management solutions that come with role-based access. 

7. Nonconformance Management 

“Nonconformance” means anything that goes wrong or is not conforming to the specified requirements. These issues can be detected by QMS software and investigated to determine the root cause and prevent recurrences. Alternatively, you can integrate a nonconformance management software with your existing QMS to identify, record, and manage defects and deviations. A software will also help you categorize quality based on their risk severity and rate of occurrence so you can focus on the major, moderate, and low level risks accordingly.  

8. Risk Assessment 

An assessment of risk involves comparing process performance to internal or external metrics, such as industry benchmarks. A quality manager, an internal auditor, or an external inspector typically conducts assessments. It will help if you will utilize CAPA management software for streamlining risk assessment and management processes. A robust software will also help your quality teams take a proactive approach towards quality issues to prevent catastrophic results. 

Related Articles: Risk Assessment Vs Risk Management: How Are they Different?

9. Audits & Process Improvement 

A quality management system should continually improve business processes. An effective QMS will include QC as well as CAPA (occurrence management). Furthermore, we recommend that you invest in audit management software to recognize and automate significant improvements to internal processes. The right audit management software will help you quickly analyze the quality trends to make informed business decisions while eliminating all the inconsistencies from your quality system. It also drives continuous improvements. 

10. Excellent Customer Service 

The goal of every business is to offer excellent customer service. Therefore, the quality management system should maximize customer satisfaction by consistently delivering high-quality products and other services. In addition, businesses should understand their customers’ needs and use feedback/complaints from them to improve. So, it would be best to use a complaints management system to track customer complaints and respond to them in time. 

11. Facilities and Safety 

An organization’s safety, security, and cleanliness depend on well-defined procedures and standards. It includes physical security, safety procedures, and ergonomics. An organization must have a well-defined set of policies in place covering all the aspects of security and hygiene. A suitable quality management software can help you create and circulate all the quality related documents across the organization efficiently. It further ensures that all your quality teams are on the same page, regardless of their geographical locations. 

The Role of Software in Quality Management 

According to ISO, quality management is the coordination of activities that a company undertakes to control and direct quality. 

A QMS must include all 11 critical elements for consistently high-quality operations and ensure that these elements work together. If your QMS lacks several aspects, such as document control or physical security, it can easily collapse. A QMS that complies with all the basics but fails to coordinate between them by considering quality trends or root causes will put your business at risk. 

Creating and maintaining a QMS is easier because ISO standards don’t require software. But a paper-based quality process can be challenging to maintain because of poor visibility and human intervention. Rather than building a QMS from scratch, you can use software to reduce the amount of work needed. 

Utilizing the right quality management software can save you money, efforts, and time to invest in core-business activities by streamlining and standardizing your core processes. Furthermore, you can create a closed loop quality system to manage things more effectively and efficiently. 

With Qualityze’s cloud based QMS, businesses can ensure their quality management processes meet ISO and FDA guidelines. In it, you will find all the essentials for creating solid quality baselines for all kinds of businesses- Big, Small, or Medium.  

Qualityze EQMS is built on the most powerful and secure platform, i.e., Salesforce.com to ensure maximum flexibility, security, and scalability to manage your quality processes. It comes with amazing in-built capabilities such as Reports, Dashboards, Audit Trails, Digital Signature, Chatter, and much more. Check out more about our solution here. 

Alternatively, you can 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. 

Consumer Goods: Benefits of Automating Quality Management

Benefits of Automating Quality Management in Consumer Goods Industry

Product recalls, lack of traceability, and data integrity issues can affect the business’s bottom line especially if you are manufacturing consumer goods. You must implement proper quality controls in place to ensure consistent quality products and processes. You can utilize a next-generation quality management software to align your key processes with the quality objectives. 

Consumer Packaged Goods is one of the most competitive sectors where customers can switch to any brand, based on the quality and cost expectations. However, the demand of the consumer goods stays consistent. Delivering the right quality to the customers on the right time can help maintain customer loyalty for a longer term. 

To ensure continued success and profitability, it is critical for consumer goods manufacturers to streamline and standardize the quality processes in accordance with industry-proven best practices. Relying on manual processes can be overwhelming. It would be best to implement a next-generation enterprise quality management software.  

Automating quality management processes for consumer goods industry can drive multiple benefits, including: 

A better reputation for the brand 

Gaining customer loyalty is the key to improving the brand’s reputation in any industry, including consumer goods. Customer confidence and trust in your brand can be shattered by just one quality failure. In addition, you must have confidence in the processes you use. To gain the confidence the consumer goods industry needs, quality management software streamlines and standardizes the company’s functions based on customer and compliance requirements. QMSs also enable businesses to drive continuous improvements that contribute to an improved bottom line, better customer experience, and improved brand reputation. 

Reduction in Quality-Related Costs 

Despite the constantly changing buying behavior of customers and the ever-evolving challenges faced by consumer goods companies, minimizing quality costs has always been among the top-quality objectives. Quality management software provides a closed-loop quality management system for managing product quality and processes efficiently. It decreases defects and nonconformances, which in turn reduces resource wastage. In addition to saving on infrastructure costs, cloud-based quality management solutions can also reduce other overhead expenses for consumer goods companies. 

Streamlined Business Processes 

The consumer goods industry needs to follow best practices and processes to meet changing customer expectations and comply with increasing compliance pressures. A quality management system that aligns the critical functions of the business with quality objectives is the only way to achieve this. Additionally, a QMS may assist organizations in improving their business processes by building a culture of quality and continuous improvement. As a result of improved business processes, products are better, which translates to more significant market share and customer satisfaction.

A Better Supplier Process 

It is common for consumer goods companies to work with many suppliers to provide the best products at the right time. The challenge lies in managing the records of many suppliers, including SLAs, invoices, and many other documents, and evaluating their performance regularly. Performing these processes manually isn’t efficient anymore. Using quality management software can help businesses manage all the processes related to suppliers, including selection, documentation, audits, and more. In other words, a QMS enables companies to take a proactive stance toward improving their suppliers’ processes and relationships. 

Improved Decision Making 

The increasing compliance and regulatory requirements have made traceability and visibility of business processes and information increasingly important. To address these complex challenges, consumer products companies require data analysis tools that help them analyze available data, reduce operational risk, resolve adverse events, reduce product recalls, deliver compliant products on schedule, and avoid noncompliance. With advanced reporting and analytics tools, the next-generation quality management software enables organizations to meet all their quality goals in a hassle-free manner. 

Low product defect rates 

Consumer goods businesses cannot reduce product recalls and nonconformances through manual processes and systems. Instead, a proactive risk management approach is needed.  Consumer goods companies can manage risk more effectively using a quality manage 

ment system, which results in fewer defects, recalls, nonconformances, and noncompliance. In addition, you can conduct regular quality audits through a robust QMS to continuously improving quality. 

Increased Organizational Effectiveness 

QMSs help to establish important operational goals while providing a means of tracking your organization’s progress on reaching these goals. The advanced quality management software often comes with dashboard functionality that provides instant insights into the overall performance and task progress. 

Enhanced Customer Satisfaction 

Customers are the lifeblood of any business; incorporating their feedback into your QMS results in greater customer satisfaction. you can also integrate the customer complaints management system with QMS to manage reported issues more effectively and efficiently. 

Improved Compliance 

A quality management software integrates compliance into documentation, measurement and reporting systems, and internal auditing systems, thereby easing some pressure to meet key standards and regulations. Credit goes to the new-age technology, you can leverage integration capability to have better control on data and processes.  

Better Organizational Culture 

To understand what is expected from your quality team, a quality management system establishes, communicates, and aligns operational activities with organizational goals and priorities. It enables you to establish a culture of quality wherein everyone is responsible for maintaining highest standards of quality. 

Controlled Documentation 

A quality management system will document critical processes and objectives to ensure knowledge and information is shared throughout the organization. However, you can also integrate a cloud-based document management solution for improved document control, version control, and audit trail. You can easily find the document management solution that supports electronic signature for meeting compliance with regulatory standards such as FDA Part 11. 

But you can leverage all the above-mentioned benefits only when you choose the right quality management software for your business needs. One of the highly recommended EQMS software for Consumer Goods Industry is Qualityze EQMS Suite. 

Qualityze EQMS Suite is an integrated, cloud-based solution that enables consumer goods companies to gain more visibility into the data collected so they can proactively:   

  1. Cut down the operational costs   
  2. Ensure quality product delivery timely and consistently.   
  3. Prevent defects and deviations by driving continuous improvements   
  4. Ensure better traceability and flexibility to manage quality processes.   
  5. Collect and work data to make informed business decisions, and much more.   

Built upon the world’s most secure and reliable platform, Salesforce.com, Qualityze enables your quality teams to manage key processes from anywhere across the globe.   

With the Qualityze Enterprise Quality Management Solution, you can adopt industry best practices and easily configure predefined workflow templates that enable you to meet quality, compliance, and regulatory requirements. For a total QMS solution, Qualityze’s integrated design ties all processes together. It comes with amazing functionalities such as Email Approval, Centralized Database, Dashboards, Advanced Reporting, Audit Trail, and much more. 

Related Article: How A Centralized Database Makes a Difference?

Conclusion 

To meet customer demands, manufacturers must take measures and implement workflows. Digital tools such as advanced quality management software, which automates workflows, can help manufacturing companies improve their product traceability and maintain quality data.   

For more information, please get in touch with our customer success team at +1-877-207-8616 or email us at info@qualityze.com, and we will be there for you. 

Does PDCA Cycle Encourage Continuous Improvements?

Does PDCA Cycle Encourage Continuous Improvements? 

“Strive for continuous improvement, instead of perfection.” – Kim Collins 

And continuous Improvements requires organizations to implement changes often.  

We will firstly understand the term Continuous Improvements before discussing the tools and techniques that are useful for it. 

A Brief Introduction to Continuous Improvements 

Continual improvement refers to creating products, services, and processes incrementally or in a way that is a breakthrough from one generation to the next. For Continuous Improvement, there are several techniques, and within the same company, many different approaches are employed, as different approaches are better suited to specific uses. 

Through CI Processes, companies are continually improving the quality of their products, services, or processes. 

What are the Objectives of Continuous Improvements? 

Continuous Improvements basically aim for: 

  • Increasing employee engagement and collaboration 
  • Process tracking and systematization 
  • Minimizing variation 
  • Reducing defect rates 
  • Speeding up cycle times 

What Drives Continuous Improvements? 

There are numerous sources that can trigger the CI processes in any organization, including: 

  1. Regular Audits 
  2. Changing Compliance Requirements 
  3. Growing Customer Expectations  
  4. Customer Complaints 
  5. Document Changes 
  6. Technological Upgrades, and much more. 

Related Article: Leverage the value of customer complaints for continuous improvements

What are the Benefits of CI Processes? 

Previously, we discussed Continuous Improvement’s objectives, so let’s explore the reasons and how the right processes can lead to exponential productivity gains. Over time you will add substantial value to your services or products if you have a process in place. Continuous improvement processes offer the following benefits: 

1. Consistency and Iteration 

Consistency and iteration are the most significant benefits of continuous improvement. Innovative approaches, such as iterative approaches, are beneficial for supporting rapid changes. In an iterative process, discovering risks and problems is more effortless. In addition, learning occurs when you iterate, so you’ll continually improve. 

2. Better flexibility 

An organization’s improvement process provides flexibility. For example, innovative companies, such as Tesla, Google, or Haier, are always conscious of their environmental impact. Thus, they can adapt quickly and stay ahead. 

As a paradox, flexibility brings stability. Stability is critical in ever-changing markets. It’s easy to get messy without a steady base. On the other hand, flexible organizations are highly resilient and stable in crises and rapid change. You’re usually fragile if you’re not agile. 

3. Better-quality products 

In any continuous improvement process, identifying opportunities for improvement is one of the critical objectives. It improves planning and reduces defect rates. Gradual improvement leads to significantly improved quality over time. 

4. Greater productivity and efficiency

Establishing a process is also a great way to improve productivity. It eliminates redundant work, reduces errors, and raises efficiency. 

5. Cost Savings 

It might not be easy to reduce costs. Continual improvement, however, comes with the added benefit of pointing out inefficiencies that you can eliminate. For example, it might be possible to automate redundant tasks, to ensure accuracy or consistency in work, and so forth.

6. Waste Reduction 

Continual improvement processes focus on preventing and removing waste to maximize efficiency. Different companies might have additional waste to eliminate. Materials, labor, vast surpluses, and other resources that are not valuable to your company are most frequently targeted. 

So, what’s the best way to achieve Continuous Improvements? 

The Deming Cycle is among the most common approaches to Continuous Improvement (of quality) in Lean manufacturing. There are other names for the process, such as Deming Wheel, Shewhart Cycle, and Continuous Improvement Spiral. Typically, the Deming Cycle involves four steps that are carried out repeatedly to achieve continuous improvement. These are PLAN, DO, CHECK (STUDY), and ACT. 

Walter A. Shewhart introduced the idea of Plan, Do and See in the 1920s. Deming modified Shewhart’s cycle into PLAN, DO, CHECK, and ACT. Deming cycles are like Kaizen thinking and Just-in-Time (JIT) manufacturing. PDCA illustrates theory-experiment-evaluation-do-check (like Bacon’s Scientific Method). 

PDCA also comes in another version called OPDCA. This new “O” stands for observation, which also relates to grasping the current condition. There is a strong emphasis on observation and the current state throughout the literature on Lean manufacturing/Toyota Production System, making sense when you take the whole picture into account. 

Deming Cycles offer numerous benefits across a wide range of corporate functions. These include: 

  • Managing daily routines for individuals and teams 
  • Identifying and solving problems 
  • Planning and management 
  • Continuous improvement 
  • Supplier Management 
  • Management of human resources 
  • Development of new products 
  • Testing new processes 

PDCA Cycle: The Four Phases 

PDCA cycle is a systematic way of solving problems and implementing solutions. Let us take a closer look at each stage: 

Plan 

Start by identifying and understanding the opportunity or problem you are facing. For example, possibly your marketing campaign should improve efficiency, or perhaps your finished product isn’t reaching the exemplary standards. First, invest time in reviewing the available information. Then, develop a solid implementation plan by generating and screening ideas. 

As much as possible, be specific with your success criteria. They will be addressed further in the Check phase. 

Do 

A small-scale pilot project is a safe way to test a potential solution. Taking this approach will allow you to determine whether your proposed changes achieve the desired result – and if they don’t, how little disruption will they cause. For example, you could conduct a trial within a department, a limited geographic region, or even within a specific demographic. 

Gather data on the success of the pilot project. In the next stage, you’ll need it. 

Check 

To determine whether your idea was successful in Step 1, examine the results of your pilot project with what you expected in Step 1. 

 If it is successful, proceed to Step 4. Otherwise, proceed to Step 1. 

The Do and Check phases can be repeated after making more changes. But if you fail, go back to Step 1. 

Act 

Implementing your solution takes place here. However, remember that PDCA/PDSA is a loop rather than a discrete process. The improved process or product becomes the new standard, but you are always looking for ways to improve it. 

When to Use a PDCA Cycle? 

All types of organizations can benefit from a PDCA/PDSA framework. You can use it to improve any process or product by dividing it into smaller steps or phases and then figuring out how to improve each. 

Specifically, it can set you up for success in implementing Total Quality Management and Six Sigma initiatives. However, PDCA/PDSA cycles can take considerably longer to complete than a gung-ho, straightforward implementation. 

Related Article: Difference between Quality Management System and Total Quality Management

It is not suitable for a problem that needs immediate attention might not suit this method. In addition, it requires significant buy-in from team members and often does not provide the opportunity for radical innovation – What your organization needs. 

In addition to driving continuous improvements, you must implement the PDCA cycle whenever: 

  • Implementing a new improvement project 
  • Improving the design of a process, product, or service 
  • Determining a repetitive work process 
  • Collecting and analyzing data to verify and prioritize problems 
  • Implementing the change 

Now that you know how helpful PDCA cycle is to continually improve, you should automate the cycle processes with the help of right quality management software. 

One of the reliable eQMS Solutions you can pick is Qualityze EQMS Suite. 

By integrating Qualityze Enterprise Quality Management Software Solution with your organization’s organizational culture, you can align all critical processes with quality objectives, compliance regulations, and customer needs. It will simplify the journey of change and continuous improvements for you and your team members. 

To know more about Qualityze EQMS Suite and request a free demo, please contact our customer success team today on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you. 

Why Should You Implement A Powerful Inspection Management System?

Why Should You Implement A Powerful Inspection Management System? 

Managing quality is more than just hiring the right people. It involves streamlining the critical processes such as inspections that can save your business from avoidable risks.  But managing ongoing results, continuous assessments, and inspections take substantial work time and effort. 

Since the quality of raw materials directly impact the quality of the product you deliver, you need to perform regular inspections at different stages of production. Therefore, you must have a powerful inspection management system in place to simplify the entire process, 

Implementing the right inspection management software to manage, monitor, and track material quality would be best. 

What Exactly Does an Inspection Management Software do? 

A reliable Inspection Management software enables you to define, approve, and control incoming inspection plans. Clearly define the characteristics that need to be examined, including attributes (pass/fail), variables (nominal and tolerance), and checklist items. You can also reference current drawings and standard operating procedures (SOPs) by integrating your existing document management system

How to Choose the Right Inspection Management Software? 

Choosing the right inspection management software is challenging, especially when you have plenty of options available online. So before making the final purchase decision, make sure your inspection management software helps you to: 

Mitigate Supplier-Related Risks 

The Inspection Management solution you choose should help you focus on critical suppliers to reduce risk and cost of quality. Ask these questions: 

1) Whether the solution allows you to define a sampling system? 
2) Is it possible to use skip lot logic and switching rules? 
3) Whether the solution allows you to define the acceptance quality limits (AQL). 

Related Article: A Quick Guide to Understand AQL for Inspections

With all those capabilities in-built, Inspection Management software simplifies it to monitor and control your incoming inspection requirements. The system should allow you to track which suppliers pass or fail to receive inspections and automatically reduce or tighten inspection accordingly. In addition, it will help you monitor your high-risk suppliers and materials efficiently and fetch the data you need to optimize your supplier base. 

You’ll also reduce the overall cost of quality by streamlining inspections for low-risk suppliers as and when they are needed. 

Control Incoming Quality Requirements 

The application should provide you with the capabilities of defining, approving, and controlling incoming inspection plans. Ensure you can outline Inspection-specific characteristics, such as attributes (pass/fail), variables (nominal/tolerance), and checklist items.  

Streamline Supplier Inspections 

When an inspection is due, you can be confident that your inspectors measure the correct characteristics for each product. Choose the Inspection Management software that automatically displays the current inspection plan, related documents, and sampling plan for each lot to be inspected. It helps you to ensure compliance and control while maintaining an efficient incoming inspection process. 

You can easily find next-generation inspection management software with personalized dashboards and email notifications to give your inspectors quick access to incoming lots that are awaiting inspection. It further simplifies data entry by automatically displaying the number of samples to be taken based on both the pre-defined sampling plan and previous inspection results. As a result, inspectors can quickly see which characteristics need to be inspected and record results for each sample. 

Integrate with Existing Business Systems 

Detecting raw materials that do not meet quality standards can help you avoid the costly and hazardous effects of manufacturing products with defective parts. That’s why you need an Inspection Management solution that seamlessly integrates with your existing ERP system to obtain receipt information and triggers the incoming inspection process. 

The integration capabilities help streamline your investigation and resolution process for incoming quality defects, late/early deliveries, or over/short lot quantities. For example, when a lot fails delivery checks or incoming inspection, the system automatically generates a defect record. In addition, it allows you to address supplier defects before their materials enter your manufacturing process. 

Monitor Delivery and Inspection Trends 

Inspection Management’s reporting capabilities take the guesswork out of managing your supplier base. For example, you can utilize trend reports to identify high-risk suppliers and products so that you can make informed, impactful quality decisions. In addition, when provided with capabilities like automatic scheduling and email notifications, you can keep your team updated on incoming quality trends and data. 

Keep Inspection Records and Data Secure 

The biggest concern that businesses have is the safety of their data. Unfortunately, you can only automate your inspection management process with the confidence that your data is protected. The advanced inspection management solutions provide role-based security, password authentication, and a complete audit trail. These features help you facilitate IT and industry compliance with requirements for electronic signature and electronic records, such as FDA 21 CFR Part 11 and EU Annex 11

In addition to the capabilities mentioned above, you can consider the inspection management solution’s cost-effectiveness, flexibility, and reliability.  

What are the benefits of Implementing the Right Inspection Management Solution? 

There are multiple benefits of implementing the right inspection management solution, including: 

  • Proper Training Control 
  • Faster Audits 
  • Streamlined Compliance 
  • Improved Decision Making 
  • Better Risk Management 
  • Increased Employee Engagement 
  • Enhanced Customer Service 
  • Improved Business Relationships 
  • Lower Product Recalls 
  • Accelerated Production Cycles 
  • Increased Brand Reputation 

Read more here: 11 Reasons You Must Upgrade to an Inspection Management Software

Best Inspection Management Software: A Quick Recommendation 

Now that you know implementing a powerful inspection management software is beneficial for your business in every aspect, you may want to get started with your inspection management software as early as possible. The only stumbling block you have now is research for the solution having the capabilities mentioned above.  

But we have got you covered with a quick recommendation. 

You can simplify managing incoming quality with Qualityze Inspection Management Software.  

It streamlines incoming inspections and makes sure you inspect the right product from the right supplier at the right time with our risk-based workflow. It is a one-stop solution to manage inspection practices at single or multiple sites with global visibility into incoming quality. 

Qualityze Inspection Management utilizes standard processes to help you: 

  • Create a sampling plan, inspection standards, inspection types, and purchase orders 
  • Perform Inspections 
  • Verify Samples’ Variables and Attributes 
  • Implement a severity-based sampling plan to ensure more stringent inspections 
  • Generate an NC for samples that fail inspection criteria 
  • Identify materials that require re-inspection 
  • Integrate with ERP systems for Purchase Order information 

StartUs Insights Recognizes Qualityze Inspection Management Solution Among Top 5 Inspection Solutions for Process Industries. To read full article click here.

Qualityze’s closed-loop, industry-leading cloud platform delivers process integration like no other solution. The electronic signatures, audit trails, validation packs, and electronic reporting of Qualityze give you control and confidence. As a result, we provide Next-Generation solutions for your business success, regardless of whether you want to automate just a single process or optimize your complete quality management system. 

If you have any questions about Qualityze Inspection Management, you can reach out to our customer success team directly by calling +1-877-207-8616 or emailing info@qualityze.com. Our team will assist you at your earliest convenience.       

Pareto Chart Analysis: When & How to Use It?

Pareto Chart Analysis: When & How to Use It? 

Pareto chart commonly referred to as quality improvement tool, is based on the Pareto Principle that 80% of outcomes can be predicted based on 20% of inputs. It works well for setting priorities and driving continuous improvements by providing insights on the frequency of the quality issues and their root cause. 

By using Pareto Chart, you can: 

  • Identify problems/issues according to their cause or details, such as: 
  • Information such as defect type, place, position, approach, process, and time. 
  • Cause such as tools utilized, project execution, client communications, resources, etc. 
  • Find out what causes the most problems and what makes them worse. 
  • Select a problem or cause of a quality issue to focus on first. 
  • Chart the improvement before and after to understand the effectiveness of the solution. 

Pareto charts reflect the theory that the few most significant defects account for most of the overall problem. Thus, Pareto charts help find the systemic flaws that contribute most to the cumulative effect of the issues. 

What is the Purpose of the Pareto Chart? 

With the Pareto chart, you can highlight critical elements of a (typically large) set of factors. For instance, in quality control, a Pareto chart may often represent the source of the most defects, the most frequently occurring defect type, or the most frequent basis for customer complaints, among others. 

The Pareto Chart analysis is used in industries including lean manufacturing, automobiles, food and beverage, and more to focus on core improvement areas. 

Pareto Chart Analysis: When to Perform It? 

You can use the Pareto Chart Analysis, especially when you want to: 

  • Analyze the frequency of problems in a specific process 
  • You want to focus on the most prominent issue or cause out of many 
  • Have a closer look at the highlights of root causes 
  • Communicate your findings 

Pareto Chart Analysis: How to Perform It 

Next, we will see how to perform a Pareto analysis: 

Identify and list your problems 

Identify all the issues you need to resolve and make a list. Gather feedback from team members and clients, where possible. You could do it through surveys, formal complaints, or helpdesk logs. 

Identify the Root Causes for Each Problem 

To solve each problem, you must first identify its root cause. A combination of a 5 Whys analysis, Cause-Effect Analysis, and Root Cause Analysis is a valuable tool. 

Related Article: Explain the Five-Why Analysis to Determine Root Cause(s)?

Assign Scores to your problems based on the severity 

Now, rate the importance of each of the problems you listed. It usually depends on what you are looking to solve. 

Organize your problems together 

You can group problems by a common cause you identified in Step 3 by utilizing the root cause analysis. For example, three of your problems are caused by an inadequate calibration of tools. In that case, these three problems can be grouped. 

Calculate the total score for each group 

Sum up the scores for each group you identified. Once again, it would be best to prioritize the groups with the highest scores, and those with the lowest scores should be the lowest. 

Be proactive 

Now is the time to act! If you solve the highest-scoring problem first, you will likely reap the most significant rewards. So, think of innovative solutions to your highest scoring problem first. 

It might not be worth making a fuss over the lowest-scoring problems, especially if they are expensive to fix. Instead of wasting energy and resources on unimportant things, use Pareto Analysis! 

Pareto Chart Analysis: Benefits to Expect 

The concept of the Pareto Chart affects numerous business and economic factors, including financial performance, process improvements, and customer retention. However, the real benefits come in the form of its ability to help companies identify their most significant assets and maximize their value.  

Some of the benefits of using Pareto Chart Analysis: 

  1. Improved Decision Making: By identifying the immediate causes for change, businesses can prepare their departments and team members to adapt and deal with the changes quickly. 
  2. Overall Improvement of Organization: Allows management to prioritize tasks and solve problems more efficiently by focusing on the most critical aspects of the job. 
  3. Better Problem Solving: Locates the root causes of problems and understands how to take better action. 
  4. Resource Reallocation: You can reallocate resources using productivity and time management tools to achieve business objectives efficiently and effectively. 
  5. Market Optimization: Research top-performing products and create marketing campaigns for specific audiences. 

Example of Pareto Chart Analysis 

An example could be an error that caused due to a part being made that does not fit into a machine assembly as expected:  

pareto chart

In the above example, the scores are assigned, out of 10, based on severity. The highest scoring cause will be managed on priority, while similar scoring can be grouped and worked together. 

Unfortunately, without a tool to capture, detect, and eliminate such problems, such work is cumbersome, labor-intensive, and prone to mistakes. However, you can manage such root cause analysis using advanced CAPA Management Software like Qualityze CAPA Management. 

Qualityze CAPA Management solution is specifically designed to manage systemic issues and prevent recurrence in the future effectively. 

Quality tools like Pareto Chart Analysis, which are built-in as a part of the Qualityze CAPA Management module, help you perform root cause analysis quickly and efficiently. In addition, CAPA Management Software’s intuitive user interface and configurable workflows make the transition from traditional CAPA processes to a powerful tool simple. 

You can also integrate Qualityze CAPA Management with existing business applications to identify, manage, investigate, and eliminate quality problems using different root cause analysis tools with confidence and accuracy. 

Key Observations 

Using Pareto Analysis, you can evaluate and prioritize various problems or tasks by comparing the benefits of each. 

It represents the Pareto Principle (also known as the 80/20 Rule) – the theory that 80 percent of problems are caused by just 20 percent of causes. 

It is necessary to list all of the problems you face and the root causes before using Pareto Analysis. Then, once you have identified each issue, you should score it according to its severity (the scoring system you rely on will depend on what kinds of problems you are trying to handle). 

For each cause, group problems by score. This will allow you to identify the issues that will have the most prominent benefits if resolved. 

Finally, use the information you have collected to prioritize your workload so that you can devote more time to improving the issues that matter most and less time to problems that do not. 

However, you can make the best of this technique by integrating it with an advanced CAPA management System.

If you 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. 

Advantages and Disadvantages of Instructor-Led Training 

Advantages and Disadvantages of Instructor-Led Training 

The importance of training for organizational success cannot be overstated. Employees and employers both benefit from it. With the proper training, an employee will become more productive and efficient. 

In addition to increasing employee competency, it prepares them for more significant roles and responsibilities. Furthermore, it enhances their knowledge and skills to manage competitive challenges more effectively and efficiently. Training is generally categorized into two forms: Document-Based Training and Instructor-Led Training. 

Though Instructor-Led Training is the primary form of learning for many organizations, it has certain limitations that compel organizations to find new and innovative training management solutions.  

Related Article: 3 Benefits of Training Management Solution

In this post, we will dig deeper into the advantages and disadvantages of instructor-led training.  

To begin with, what is Instructor-Led Training ? 

It refers to classes led by an instructor rather than self-paced, on-demand ones. Integrated learning with technology is an example of synchronous learning, in which learning takes place in real-time.  

Different types of ILT are available, including:  

  • Face to face training delivered in person 
  • Virtual live training conducted online using webinar applications or other virtual facilities 
  • Private classes tailored to fit the needs of the customer 
  • Public courses open to any interested individuals 

Is ILT a good fit for my company? 

An instructor-led training course can significantly benefit companies that wish to customize their customer and employee training based on the quality and compliance requirements. 

What Are the Advantages of ILT? 

Instructor-led training has several advantages: 

1. It provides an opportunity for open dialogue 

ILT facilitates open dialogue. An ILT provides learners with opportunities for collaboration through open discussions and engagement activities that enrich learning.  
Furthermore, instructors can read the body language of the class and alter direction according to the learners’ needs at the moment. 

2. It connects people to learn 

Students will build organic relationships in the classroom by attending the training for a few minutes or several days.  
Participants can rely on these relationships that form before, during, or after their training to build a learning network.  

3. It offers flexibility 

A great advantage of ILT is its flexibility. Instructors can provide additional clarification on the participants’ requests. 
Also, the instructors can observe whether learners understand a concept or struggle with it during a session.  

4. It has no distractions 

In general, 49% of learners are distracted by digital tools for reasons other than learning.  
Thanks to ILT, learners can concentrate more easily. In addition, participants will retain more information if instructors create an engaging learning environment.  

5. A fun and interactive experience 

The activities that participants can complete with ILT make the course engaging and interactive.  
It is best to learn from others to help participants retain information over time and build stronger relationships with colleagues. 

What Are the Disadvantages of ILT? 

Instructor-led training has several disadvantages: 

1. It Costs a lot

ILT has the disadvantage of being expensive. Consider these factors before planning an ILT: 

  • Booking a rental space 
  • Instructor Fee 
  • The cost of travel (flights, gas, accommodations, meals, etc.) 
  • The cost of equipment 

2. It requires you to take time off from work

It takes time away from work regardless of whether you are traveling across the country or staying local. ILT Programs may have sessions that range from a few hours to a few days or even weeks.  

3. It trains fewer people at once

It is ideal to have a smaller number of participants for ILT sessions so that they can be engaging and interactive. It will probably take an instructor multiple sessions to cover all learners.
Moreover, maintaining training consistency becomes a challenge when instructors try to recreate the same session a number of times. 

Related Article: Employee Training Management System: 7 Critical Features you Should Look for

But what if you could escape the disadvantages of Instructor Led Training and can still leverage all its benefits to train your teams especially when they are working remotely? 

Yes, that is possible! 

How? 

You just need to find the right Cloud-based Training Management Software that can fit your business and compliance training needs. 

One of the most reliable training solutions is Qualityze Training Management. 

Qualityze training management is a cloud-based, intuitive, and comprehensive solution designed to manage, execute, and maintain your organization’s training programs. It allows you to organize all the training essentials your company’s training team requires, including certifications, qualifications, and training records in a central repository, to remain compliant with internal and external requirements.  

You can create specific training requirements by setting up relevant job functions for a department, business unit, process, location, site, and individual. Qualityze Training Management is seamlessly integrated with Document Management System to define training requirements of SOPs, procedures further, and work instructions. In addition, utilize refresher training options and define pre-requisites to enhance training requirements.  

Qualityze Training Management comes with two types of training processes, document-based training, or instructor-led training. The Document-based training can be Read and Sign off or have employees go through a Read and Sign Off with Assessments. Additionally, employees can be added individually or through Job functions.  

The instructor-led training allows creating the creation of courses where the employee can enroll, withdraw, perform an assessment, get manager approval, and many more. As the instructor, you can create multiple course sessions, manage the start date, end date, roaster list, attendance of the participants, and assessments.  

Enhanced dashboard capability allows you to monitor the progress of your training and your direct reports, real-time.  

Qualityze Training Management is a comprehensive solution to streamline the training programs for your employees to increase their efficiency and productivity. Combined with powerful analytics and reporting capability, you can perform trend analysis and gap assessment to proactively respond to training requirements that drive continuous improvement and regulatory compliance. 

After all, managing and maintaining employee training records is one of the key parts of quality programs of any company – big or small. 

Still Thinking? 

Do you want to start building your ILT? Would you like to know more about other functionalities a cloud-based training management solution can offer? Please contact our customer success team directly at +1-877-207-8616 or email us at info@qualityze.com, and we will be there for you.