The Internet is flooded with information on quality management systems. While many of them are genuine resources, there are some circulating inappropriate information, myths, and partially correct information that often misguides people.

In fact, people overlook all the benefits and their business needs for an advanced quality management system without even realizing that it’s holding them back from gaining a competitive edge. This post is intended to debunk all the myths about quality management systems and help business owners to make an informed decision regarding EQMS implementation.

Some of the common myths are:

QMS requires intensive paperwork and documentation

Many business owners believe that they will need to do extensive paperwork and documentation if they will implement an ISO certified quality management software. However, this works counterproductive. A company producing an excess of documentation will only increase complexities for the organization as well as customers to retrieve required data and information.

Such organizations need to understand that even the most popular regulatory authority i.e. ISO majorly requires six documented procedures to streamline, standardize, and structure organization’s processes. This further induces the confidence and trustworthiness of the organization for its respective audience.

The misbeliefs about documentation often keep many organizations to reap the maximum advantages of a quality management system and maintain compliance.

QMS is not a value-addition for an organization

Some organizations adopt a quality management system just to keep their customers. They don’t understand the value it adds to the organization in terms of improved performance and profitability. One of the main reasons could be the lack of clarity on the purpose that organizations want to fulfill with QMS.

The fact is quality management system is a value-addition for any organization to reduce the chance of quality issues while saving time, money, and resources. A QMS helps to establish a disciplined process and clear communication across the organization to ensure standard procedures that not only increase ROI but also increase the brand value for the customers.

The myth about zero value addition from the quality management system holds the organization back from the improved bottom line.

QMS just increase cost-burdens on the organization’s budget

Investing in quality management software may sound like cost-burdens to the organizational budget especially if you cannot implement best practices for everyday tasks. It will simply be of no or very minimal value for the organization to achieve operational excellence.

However, the investment in a quality management system will be a total worth if it is implemented appropriately. It will help the organization to take a proactive approach for quality issues so as to prevent expensive product recalls. It is much better than managing the consequences of a problem that could take your customers and brand reputation away.

Therefore, the cost for the organization might increase a bit with an investment in the quality management system, but it is totally worth to avoid expensive recalls and rework.

QMS makes our organization processes rigid and regressive

Organizations tend to experience rigid and regressive processes only when it is structured so. It’s not the quality management system that binds an organization from being flexible and innovative with their everyday processes. It’s more about the way they align their processes with quality objectives.

A quality management system enables an organization to be more flexible and innovative by providing them a structure that truly aligns with their quality objectives without compromising on standards and compliance. You can also go for a cloud EQMS that leverages configurable workflows for more flexibility and ease.

So, make sure the processes align well with the objectives you want to achieve. This will enable complete flexibility and innovation in the QMS implemented.

QMS certification is not something our organization doesn’t need

It is not defined as a mandatory regulatory requirement to adopt a quality management system and get certified. This is the reason many organizations don’t realize the need for quality management systems. They often tend to ignore multiple benefits they can reap with a QMS implementation and certification.

A QMS is referred to as the collection of industry best practices that enable any organization to ensure consistent quality and compliance. And, acquiring a certificate verifies the successful implementation of industry best practices and proven approaches in the organization. It also helps the organization to gain customer confidence and enhanced market reach.

A certified QMS also makes your organization future-ready since standards are likely to get stringent and important. So, don’t let your organization lag and get certified QMS today.

QMS is more like a distraction for our business processes

This myth is made to look like a fact by many organizations that tend to use a quality management system on an on-and-off basis. They consider it an activity or process that should be conducted at regular intervals of time like an audit.

Organizations need to understand that implementing a quality management system and complying with industry best practices daily helps to create a standardized flow of processes. Having such an approach helps to achieve many benefits that are beyond any costs like customer loyalty.

So, don’t let your QMS become a distraction for the business processes. Rather, use it to create a culture of quality and continuous improvements.

QMS neither makes sense nor guarantees product quality

Nothing can work as a perfect formula to guarantee product quality. But following industry best practices and methodologies through a closed-loop quality management system ensures a proactive approach to manage problems and consistency of the product quality. It can improve the business success rate as well.

Don’t be among the organizations that consider quality management systems just a fad to last for a few more years. Consider it as a quality base for your organization’s long-term success. It will become staple with the increasing prominence of the quality management systems.

Don’t expect to guarantee, streamline and standardize your processes using a QMS to ensure greater consistency and lower product quality issues.

QMS is not required in case of customer audits and inspections

An audit or inspection conducted by one customer doesn’t necessarily ensure enough confidence as the implementation of a quality management system and certification does. It is not likely to make all your customers equally happy and satisfied.

On the other hand, being audited by the certification bodies ensure that you are following best practices daily regardless of the type of customer you are delivering your product and services to. Moreover, not every customer may qualify to perform an audit. A certified QMS implementation will ensure consistency and confidence.

A certified quality system is likely to increase every customer’s confidence in you and your products.

QMS is for the organization that doesn’t have any other certification

This is also among the myths that are turned into truth by many organizations. There are certain organizations that have gained certifications from different regulatory bodies such as GLP, GMP, FDA, UL, etc.

Gaining any of them or all of them doesn’t mean you shouldn’t have a quality management system in the organization. Adopting the right QMS is more like a comprehensive approach to attain quality rather than focusing on a process or system.

A quality management system helps to ensure that all the processes including CAPA, complaints management, training management, etc. are standardized throughout the organization and everyone is on the same page.

Unfollow these Myths in 2020 for Accelerated Growth and Quality Improvements

Don’t let any of the above-mentioned myths to block your business success. Explore all the possibilities and opportunities that 2020 holds for your business with the implementation of the right quality management system in your organization.

Change of Approach that your Organization Needs

Your organization needs a standardized approach to streamline all the quality processes while mitigating the risks and achieve operational excellence. This is possible only when you will get the quality management system that suits your business needs. The right system will help you make a proactive approach towards quality issues so that you can achieve quality objectives at the specified time.

The Bottom Line

Simply put, a quality management system helps to prevent quality issues while ensuring consistency – in products and process quality. Implementing EQMS and gaining certifications improves outcomes, lowers the quality costs, and increase confidence.
If you want to know more and explore the right quality management system for your business needs, get in touch with the Qualityze team. You will get your queries resolved and make an informed selection of the right EQMS.

The current Coronavirus Crisis has left no industry untouched. It has shaken businesses to their core and drastically changed customer behavior.

The novelty of the virus is complicating the situation, making people think about the implications that lie ahead. Evidence of what lies ahead, are the changes businesses are already making to adapt to the way they work.

Whether you are monitoring travel or public event cancellations as key indicators, – the bottom line of every business is being impacted. It’s all due to the fear of Coronavirus that business and supply chains are being severely impacted.

Cloud Solutions Help Businesses Survive the Corona Pandemic

Cloud based solutions emerged as an immediate help to businesses to maintain stable operations and support a large mobile and remote workforce.

Adapting to these new business realities, the new reality of having most of your workforce working from home, is the new business requirement. Qualityze supports this new reality with its Next-Generation Quality Management solution.

The Qualityze EQMS Suite enables you to manage your quality processes with the same “business as usual” ease and efficiency as you had prior to the crisis. Additionally, you can remotely create new Standard Operating Procedures (SOP), notices, and guidelines to keep your workforce trained and informed against the corona virus using the Qualityze Document Management module from the confinement of your home.

Make informed decisions concerning:

• Employees required to be on-site
• Procedures to protect the on-site employees
• Guidelines for late shift check-in’s or absence
• Requirements for working remotely

Secure cloud-based platforms like Salesforce.com have enabled the availability of flexible, scalable, and secure solutions to a whole new level in recent years. Leveraging these cloud-based solutions such as Qualityze EQMS can enable you to manage your quality processes from anywhere in the world.

Commitment to quality is something we all strive to achieve – in business and our personal lives – for now, and the future.

Cloud is the New Business Landscape

Working remotely is not only changing the way business used to work; it’s also helping businesses realize their ability to proactively manage a crisis, so they have minimal impact on their day-to-day operations. While many companies may still be discussing the value of Cloud-based solutions, todays current events have made it evident these systems are the future.

Businesses that had already shifted to cloud-based solutions are experiencing greater ease and flexibility in managing their operations. They can collaborate and communicate with their teams working remotely from anywhere in the world without worrying about providing employees access to company business applications.

Cloud solutions not only help businesses escape inconsistencies due to current scenarios; they can keep business-critical data safe from disaster.

The cloud has proven to be a reliable partner for business. It has enabled our economies retain the ability to function by minimizing their dependence on the physical locations to conduct business.

As companies look forward to keeping their productivity undisturbed, employees safe, and having a backup plan for when disaster strikes, Qualityze is set to help you explore its cloud solution as your insurance against any crisis.

While companies are trying to cope up with the quality management principles, process-level improvement is the one that requires continuous efforts.

The term process improvement itself implies making processes better and efficient with the time. It may be due to any change. Most importantly, it involves breaking down complex processes into easily manageable workflows. It requires organizations to be proactive towards process-level challenges.

The process level improvements may vary from organization to organization, including:

1. Change in the approach
2. Change in the methodology
3. Improvement in terms of eliminating unnecessary processes
4. Improvement in terms of process categorization
5. Addition of sub-processes
6. Revision in the way operations are managed
7. Implementation of new practices and tools

Why is Process Improvement critical for business success?

Businesses need to do things in a better and improved way to be successful. They are likely to lag if they are not paying attention to the process-level improvements since it could lead to unsatisfied customers, disengaged employees, and unnecessary delays in product delivery.

As Idowu Koyenikan rightly quoted that
“If you quit on the process, you are quitting on the result.”

If you are not focusing on process-level improvements, you may end up facing several problems such as:

1. Customer complaints regarding inferior quality product or service
2. Dissatisfaction among the team members
3. Redundancy of the work or incomplete tasks
4. Increased costs of quality
5. Wastage of resources
6. Unnecessary delays in the production or time to market.

What types of processes should be improved?

Can you name any particular process that needs no improvements? Every process needs some or other strategic improvement for better results or outcomes. And, the process can be both formal and informal.

The critical point to remember is that no matters how many different processes there are – the one thing they have in common is the ability to improve and perform better.

Process Level Improvements: 5 Metrics that Matter

Ensuring process-level improvements can work wonders for 5 Metrics that matter for business growth. Let’s quickly have a look at those metrics:

1. Efficiency and Productivity

   Maintaining a consistency in the process-level improvements helps to keep the inefficiencies minimum and productivity maximum. The advanced quality management systems come with analytics to help you evaluate the process performance metrics. It often helps you to identify the areas that require significant improvements for better outcomes.

   The simple and straightforward rule here is – Improve processes to improve productivity and efficiency in your organization.

2. Time-to-Market and Competitive Advantage

   When you will make improvements at the process level; you are likely to decrease the product time-to-market. It will give you a competitive advantage. You will also gain customer loyalty with quality deliverables on time. Also, process-level improvements can help organizations to be more proactive in managing operational issues and maintain excellence.

   Achieve a continuous flow of value to your customers by aligning the process-level improvements with your quality objectives. It is a real improvement deal that every organization needs to make.

3. Product Quality

   If you are unable to identify your product’s quality improvements; it’s probably because your processes are not sufficient enough. You must evaluate your process performance regularly to determine the slightest of changes that could bring a world of difference in outcomes. Only then you will be able to make your processes powerful enough to manage the issues related to integration, performance, security, and much more to ensure product quality.

   To put simply, process-level improvements can lead to the higher quality product when managed and maintained regularly.

4. Customer Satisfaction

   Aligning the everyday processes with quality goals help you deliver the right product to your customers on time, ensuring higher levels of satisfaction and loyalty. Always remembers happy customers are the most valuable asset for a business since they are likely to return for more. If you can retain your customers, you are likely to experience remarkable growth for your business revenue.

   So, improving your processes can help the product quality that will eventually increase happy customers and revenue.

5. Employee Satisfaction

   Inefficient processes are one of the most substantial reasons to make your employees dissatisfied. No-one likes to be a part of a system that could fail anytime due to inefficiencies. It’s more likely to kill their interest in the work. Make sure your business process is not weak to keep your employees’ morale boosted.

   Therefore, process level improvements are essential to keep your employees motivated and engaged.

Streamlining Process Level Improvements

The commitment and plans for process-level improvements won’t work unless you are putting them in action. The best practices you need to implement right away for ensuring continuous improvements in the processes are:

1. It will help if you create a detailed plan for the process, considering every vital step so as to head for practical improvement.
2. You must analyze the process to understand the problems people may have and what alternatives may come your way
3. After analyzing the process, it’s time to actually redesign the process with significant improvements.
4. The next step calls for accommodating the resources required based on the redesigned process.
5. Is everything in place? Communicate the upcoming change to the affected team members and implement the same.
6. Lastly, you must review the process after making improvements to realize its effectiveness.

What if you can standardize the process level improvements? Sounds great, right? The increased emphasis on quality and continuous improvements is convincing enough to invest in the next-generation quality management software like Qualityze to maintain the consistency in quality and process improvements.

To summarize:

Companies need to realize the significance of process-level improvements for their quality objectives. It should be an ongoing endeavor for every company to comply not only with the regulatory requirements but also with the customer requirements for improved satisfaction.

If you want to understand more about the process level improvements and their significance in your quality management processes, get in touch with the Qualityze customer success team, and we will right there for you.

Driving continuous improvement in your organization wouldn’t be possible unless you have set some quality objectives. Even ISO 9001:2000 requires an organization to identify and document its quality objectives before heading to process-level improvements.

Well defined and managed quality objectives can significantly improve organizational effectiveness and overall performance. These objectives provide the organization a clear vision to every individual in the organization about the purpose they need to serve and to enable them to unleash the potential of the QMS.

Quality Objectives and Quality Management System

Firstly, you need to understand that there are different types of quality objectives ranging from senior management to the production department. The main objective in every single case is to encourage a culture of continual improvement through a well-defined quality management system since it helps you identify the loopholes in the existing process and improve accordingly.

The next-generation quality management systems also help you to regularly monitor and track the performance of quality objectives that are set based on the S.M.A.R.T approach (we will discuss later in the post)

Don’t keep the quality objectives limited to product quality. The objectives, rather, should reflect the goals that the organization set. They should be designed such that they drive continual improvement in every aspect.

In this digital and ever-changing phase of the economy, you cannot expect better results without doing something different from your competitors. Your quality objectives should be strategic and visionary so that it becomes easy for your teams to work towards the specific targets.

Another important reminder here is to keep the employee’s engagement and contribution rate high. You should communicate with them as and when required for the specific improvements as that can affect the ultimate goal of customer satisfaction. An effective QMS can help you fill the communication gap as well.

How to Set Quality Objectives?

As well understand that setting quality objectives is the first step in implementing a quality management system, it is important to set objectives using SMART philosophy. SMART stands for Specific, Measurable, Attainable, Relevant, and Time-Oriented. Make sure each objective is:

• Specific – All the objectives should be clearly defined to ensure that every team member is on the same page.
• Measurable – Any objective that you identify should be measurable in terms of size or degree it may impact.
• Attainable – The objectives you set should be within the organization’s capacity. There should be proper measures and methodologies established to meet the quality objectives.
• Relevant – Relevancy is also an important factor to be considered when it comes to setting quality objectives.They, rather, should be aligned with the strategic goals of the organization in terms of meeting statuary or customer requirements.
• Time-Oriented – Every objective should be time-bound. There should be a proper mechanism to access the time within which an objective can be met.

One important thing to make a note here is – Setting objectives requires active participation from the top management as they are likely to set relevant goals concerning the products and services conformance. Some of the most common examples of quality objectives are:

• Improved customer retention by 5% every year.
• Increased team productivity by 2% next quarter.
• Maintain consistency in product quality by 98%. Etc.

How to Implement Quality Objectives?

Once you have identified all the quality objectives, the next immediate step you need to perform is the effective implementation of those objectives. Here are the steps you need to follow:

Documentation

Make sure you document all the quality objectives identified and agreed to meet. Earlier there was a quality manual to refer to, but it is not required now. The updated standards in ISO 9001:2015 requires an organization to document everything for through validation and verification purpose especially during a regulatory visit. The best option you can go for is an electronic document management software that will help you record all the important data and activities like nonconformances, and the action plan implemented. You can also record the results for an evidence-backed decision-making process.

Also, keeping the quality objectives documented will help you give quick guidance to your team towards the organizational goals.

Communicate with Team

Once the quality objectives are identified and documented, make sure you communicate those objectives clearly to your team. There are various ways to establish smoother communication including awareness sessions, the establishment of a centralized platform wherein your team can collaborate and communicate. There are many quality management software that enables organizations to foster a culture of clear communication to avoid any hassles or quality risks due to miscommunication among the teams.

Also, communicating the objectives and their respective strategies to the team ensures that the entire organization is going in the right direction.

Establish Evaluation Methodology

For measuring the quality objectives, you should establish proper mechanisms for every team, department, and function. These evaluation mechanisms should be planned at regular intervals so to evaluate the need for updates or upgrades in the quality objectives. The tracking also helps you ensure compliance since you maintain an audit trail for every action performed and its respective outcome.

In short, you cannot afford to invest your time, money, and resources on the quality objectives that cannot drive the culture of continuous improvement.

Review the Objectives

Once you have set the quality objectives, you need to continuously evaluate them as well as the mechanisms established to record the on-going performance of those objectives. There are two ways to review the quality objectives, one is through the management review, and the other one is internal audits. This will help you to keep a check on process quality if the workflow is managed and maintained properly.

However, you can implement an audit management software to ensure a timely review of the quality objectives as well as the mechanisms set to evaluate their performance regularly.

Address the Risks

It is quite often a case that your organization fails meeting quality objectives due to some or other reasons. You can expect a process or workflow to generate the same results for every quality objective you set. There could be a need for process change or improvements to improve the performance of quality objectives. For this, you need a powerful quality management software that enables you to configure different workflows as per the need of the hour while helping you identify the improvements to make your existing processes better and aligned to organizational goals.

Maintaining and managing the performance of quality objectives is one of the important functions that a quality management system needs to serve. Also, it helps in making the process highly effective and efficient than before.

So, are you ready to make your process and product quality better?

Whether you call them complicated or the basic guidelines, quality standards are critical for every industry to ensure that they are meeting the minimum requirements. However, these requirements may not always fulfil customer expectations that are growing expedite especially when it comes to the automotive industry.

Quality Management in the Automotive Industry has become quite challenging in recent years due to the trends, personalized experiences, and other next-generation features that have evolved. In addition to all these factors, environmental changes have also contributed to set new guidelines and performance metrics for the automobiles under quality standards.

Any automotive manufacturer, to comply with quality standards, must have a clear understanding of the benefits that they can reap and the processes they need to streamline, standardize, and automate.

Such a huge emphasis on quality is not required just to stay ahead of your competitors, it is rather about fulfilling the basic requirements such as safety to ensure safe rides for your customers. Further, when we talk about quality, “Quality Standards” and “Quality Management System” are the two most common terms that are used interchangeably.

Quality Standards

Quality standards refer to the controlled documents such as specifications, guidelines, instructions, etc. that can be used to conduct the business in a certain manner. For example- defining product specifications, process workflows, and general work instructions.

Quality Management System

Quality Management System can be referred to as a tool that companies use to streamline and standardize their processes to meet industry-specific quality standards without any hassles. Simply put, Quality Management System is a means to attain quality standards.

Quality Standard for Automotive Industry

ISO IATF 16949 (previously ISO/TS 16949) is the most commonly used International Standards for automotive quality management, designed to standardize the assessment criteria and certification system globally.
IATF 16949:2016 is not a standalone identity, it should be implemented along with ISO 9001:2015 for establishing an effective quality management system in the automobiles industry. Before heading to further discussion, you should understand the basic differences between ISO 9001 and IATF 16949.

• You may not find all the ISO 9001 updates in the newly released IATF 16949 standards for automotive.
• ISO 9001:2015 emphasizes on the replacement of documented procedures with the digitized documents and electronic signatures while IATF 16949 still keeps the paper documents mandatory.
• ISO 9001 doesn’t require companies to have a quality manual on-site while IATF 16949 mandates one to ensure consistency of processes.
• ISO 9001 no more requires a management representative. It mandates to encourage a culture of collaboration and participation throughout the quality management starting from leadership while IATF has still maintained the legacy of a management representative.

Automotive Industry Trends That Fostered Change in Quality Standards

The trends of the automotive industry that led to amendments in the quality standards include:

• Need for improved safety especially related to carbon print due to poisonous emissions
• Evolving new technologies for a more facilitated environment.
• Keeping quality costs to a minimum even with the complex supply chains.
• New policies for transparency and good governance to avoid expensive product recalls.
• Increasing demand for vehicles while maintaining a competitive environment.

Benefits of Implementing Quality Standard for Automotive Company

The automotive industry requires stringent quality standards with specialized ISO standards and certification to keep the quality standards high especially with respect to the safety risks to the vehicle owner. A quality management system is something that the automotive industry cannot afford to miss. There are many other benefits of implementing quality standards and quality management system in the automotive companies that include:

Faster Time-to-Market Cycles

With increase transparency of the quality processes, it becomes easy for automotive manufacturers to watch the performance trends and make significant improvements to reduce the time to market. Effective quality management software for the automotive industry is the best solution to manage the quality issues that may slow down the time-to-market cycles by limiting the potential of available resources.

Reduce Quality Costs

The absence of a robust quality management solution may increase your quality costs significantly since there will be no proper system and process to manage the scrap materials, recalls, etc. It will further result in process delays and a blemished bottom line. On the other hand, keeping quality checked and assured will help you eliminate all sorts of overhead expenses that arise due to quality issues including the product recalls.

Improved Product Quality

Having the right quality management solution in place, you can ensure a proactive approach for quality issues to manage and resolve them before the product reaches to the customer and leads to the bigger troubles including life risks. A quality management system also helps you to make evidence-based decisions with their in-built analytics and reporting tools. Most importantly, continuous improvements in product quality are one of the basic guidelines by ISO.

Meeting Compliance Standards

Managing compliance risks in the automotive industry is not easy since the existing systems for quality management are not centralized. But, a compliance-friendly solution like Qualityze can make it easy for automotive companies to manage compliance issues systematically with its configurable workflows.

Improves Customer Experience

When you will have a quality control process in place, you can keep your customers happy and satisfied by delivering the quality as expected. The things like product recall that hurt an automotive company’s image the most can be reduced to a minimum. Then, you can enjoy more loyalty, more sales, and an impressive brand image.

In the end, we can say that in the highly competitive environment of the industry like automotive, it may become challenging for you to maintain quality levels. You must take advantage of technological innovation such as quality management software to manage quality, compliance, and other operational issues in a fully compliant manner.

The next-generation Quality Management Software like Qualityze eQMS is a single solution for all your quality management needs. It enables you to keep a track of suppliers as well as the component quality so that you will associate with the quality suppliers.

Additionally, it allows building effective training programs for certain activities to make your employees competent for the jobs assigned. From identifying and tracking nonconformances to resolving issues using CAPA, document change control management to customer complaints management, and training management to supplier and audit management, you can manage all the important functions through one solution.

So, are you ready to revolutionize the way quality management was conducted in the automobile industry by leveraging the innovation to survive through competitiveness?

The quality and compliance standards are continuously getting stringent for every industry including nutraceuticals. They are not as regulated as the drugs are. They rather fall under different food categories. However, you may find different legal definitions for the nutraceuticals based on the variable state laws. For example, you can refer to the FSSAI regulations for nutraceuticals pdf for the products manufactured in India and USFDA defined the U.S. regulations for manufacture and sale of nutraceuticals and dietary supplements.

What are Nutraceuticals?

Nutraceuticals are the enriched food products that not only serve the purpose of diet supplements but also offer medical benefits such as assisting in the treatment and preventing from the disease.

Nutraceuticals are the combination of Nutrition and Pharmaceutical, but they are not tested to the extent of pharmaceuticals. In fact, the regulatory requirements for the manufacturing of nutraceuticals are different. They are also referred to as dietary supplements and used up to 50-70% in the developing countries.

The significance of the nutraceuticals has expanded now in terms of health betterment and lowered the number of diseases as well as costs of healthcare.

Components of USFDA Guidance Document for Nutraceuticals

The guidance document released by the FDA for nutraceuticals contains the following components:

Current Good Manufacturing Practice (CGMP)

The CGMP guidelines for the nutraceuticals are defined for all the areas of the production. CGMP includes the sanitation standards that a company needs to follow in its processing and storage locations while guiding it the process of implementation for the process and production control systems to maintain a consistent flow of quality for every batch.

Warning Letters & Safety Alerts

Similarly, like CGMP guidelines, there are certain warning letters and safety alerts that shall be specified by the manufacturers. They also need to provide all the information that backs up the safety component of the product for human consumption. The FDA requires all such information at the time of reviewing the findings to ensure they are consistently maintained and make an informed decision on approval of the product to be further distributed in the market and being sold.

Labeling and Regulation

Providing correct information on product labeling is one of the critical requirements defined under regulations for the nutraceuticals. The manufacturers need to continuously demonstrate compliance for the FDA requirements. Nutraceuticals aka dietary supplements are intended to serve health benefits to buyers, and this must be reflected through package labeling. The labeling information should also include the claims that if the supplement’s dosage is taken in a higher amount than what is prescribed, it may induce risks.

The FDA strictly recommends the labeling and regulation for information to make consumers aware of the safe consumption limits for the particular dietary supplements they take. Hence, nutraceutical manufacturers need to follow the guidelines of labeling for consumer’s health as well as their regulatory benefits.

Correspondence, Statements, and Agreements Related to Policy

This FDA regulation for the nutraceuticals implies that nutraceuticals manufacturers must upgrade the relevant information about the products, safety consumptions, and much more as soon as new statements or agreements issued by the regulatory. It involves informing consumers about the new ingredients being introduced, new policies to state the nutritional facts that make dietary supplements different from the other beverages, and their improved health significance.

Health Claims

With the consumers getting more aware of what they eat in the name of natural health foods and functional foods, it has become important for companies to do bountiful of research to develop the improved quality food products. Most of research results into new findings and health claims that should be included in labeling to communicate all the critical information to the consumers. This makes them even more aware of the nutraceutical products they are investing in.

Qualified Health Claims

Qualified health claims are the ones that are backed by some scientific evidence, but do not necessarily meet the standard requirements that one needs for an authorized health claim. Nutraceuticals manufacturers must ensure that these claims are not misleading by providing their information through disclaimer or any other valid communicating label. This also ensures that consumers understand the scientific evidence required for qualified health claims.

Adverse Events Reporting

The manufacturers who adhere to all the compliance requirements specified by FDA must follow a practice of creating and maintaining the records of all systems, processes, and events including the ones that may adversely affect them to meet compliance. A well-defined record-tracking and reporting system help nutraceutical manufacturers to demonstrate that they have an established set of processes and procedures to manage the adverse events tactfully.

General Compliance and Inspection Information for Industry

The general compliance and inspection information is required to ensure that a consistent approach is implemented for maintaining the environmental regulatory framework. This is intended for the entire nutraceutical industry to demonstrate the regulated processes that every company needs to follow so that they market only the safe health and dietary supplements to the consumers.

Codex Activities

Codex standards and guidelines are formulated by the committees that apply to all the countries listed as members. The main purpose of defining CODEX activities is to protect consumer’s health and ensure good practices in international trade with the development of food standards. However, CODEX standards are voluntary. All the countries listed as members are not strictly required to adopt them.

This post was quite a brief on regulatory aspects of nutraceuticals. You can find out more details on the other resources available in ppt and pdf formats. Make sure you search specifically for the region you want to implement regulations for.

For example- if your manufacturers operate from India, you need to check for the resources like regulatory aspects of nutraceutical products in India pdf. For detailed information, you can also explore the history of food and nutraceutical regulations. This doesn’t imply that the implementation of regulated processes is easy. You need a compliant quality management software for nutraceuticals that can help you form a closed-loop system to ensure quality and compliance.

A Quick Help

Qualityze is one of the top-ranked quality management software you need to keep your processes streamlined and compliant. It is a cloud-driven solution that comes with configurable workflow, advanced features, and amazing in-build capabilities. This global capable solution assists you in the validation and verification process too.

You must test this solution for your nutraceuticals quality requirements by requesting a free demo today and you will get 1-week free trial. This will help you make an informed decision and figure out the configurations you might need to implement Qualityze.

Summary

Every industry including nutraceuticals must follow regulated processes to deliver FDA compliant products to the market. You can ensure regulated processes with the help of a powerful eQMS like Qualityze that can capture, record, and manage all the adverse events accurately and timely.

The continuous evolution of technology has led to many innovations and revolutions for the manufacturing industry including the most talked-about one i.e. Industry 4.0. The era of digitization has brought so many exciting changes for the manufacturing companies with cutting-edge quality management solutions.

But there are still many manufacturing issues that need to be resolved with the intervention of technology. The most common challenges that manufacturing industry is facing today includes:

Lack of a Competent Workforce

Lack of the competent workforce doesn’t imply that you don’t have good people in your organization. You may have the best people in your organization but may not be competent enough to perform the roles and responsibilities assigned to them. This requires effective training programs to be implemented so that your employees can work more efficiently.

Firstly, you need to identify the need for training programs for different departments so that you can introduce the right training programs. Then, you need a training management software to manage all your training related tasks including registration, enrollments, program creation, examination, performance evaluation, issuing certificate, etc.

Manufacturing companies should emphasize on improving the workforce competency to unleash the maximum potential from the available resources.

Lack of Safety Measures

Manufacturing can be an extremely dangerous industry at times. It is significantly important for manufacturers to comply with health and safety standards to avoid non-fatal injuries and illnesses at the workplace. A major part of these injuries is linked with lifting heavy objects that should be safely lifted with the help of trucks and trolleys.

The manufacturing companies should have an audit management system in place to know where they lack in terms of employees’ and customers’ safety and take right corrective measures to deal with the compliance and quality issues of the existing processes.

Therefore, manufacturing companies should have a regulated audit management system to identify improvement opportunities, especially for safety measures.

Lack of Awareness on Digital Transformation

Even though there has been a regular discussion about the digital transformations for the manufacturing industries, there are still a huge number of manufacturers who are not utilizing the latest technologies like Cloud, IoT, AI, etc. to maintain their competitive edge. They are ignoring the potential of such technologies for improved safety, compliance, efficiency, and cost-effectiveness in the production.

Manufacturers should create a strategy wherein they have to define the systems and processes to collect, analyze, and manage the business-critical data in such a way that it improves their decision-making process.

The focus on new and improved technologies will help manufacturers to stay smart and proactive for the upcoming business challenges and changes for continued success. So, manufacturers, take the smart way to success before it’s too late.

Lack of Inventory and Supplier Quality Management

Though managing supplier’s quality and inventory is a common challenge for all the manufacturers, they cannot rely on traditional methods to track and manage supplier quality. it’s time they need to realize the importance of a supplier quality management system for improved performance of their suppliers.

Manufacturers cannot afford delayed supply of goods and components as this can hamper both the production cycles and brand reputation. Once there is efficient management and tracking of supplier quality, manufacturers can also streamline the other processes like inventory keeping for the raw products, finished products, and the products that are still in the production.

Make sure you manage your supplier quality right to keep your production quality high, which will help you to maintain the balance of quality and quantity of the deliverables.

Lack of Effective Tools for Risk Management

Managing risk is yet another important aspect for the sustainability of any business including manufacturing. Effective risk management requires you to consider and evaluate different aspects, which is time-consuming if executed manually. The use of next-generation CAPA management software is a smart move to identify potential risks and manage them.

CAPA Management Software brings dual benefits for manufacturers. They cannot only identify the potential risks but can also manage the quality issues that have already occurred to prevent their recurrences. It is indeed one of the most effective risk management tools for manufacturers.

A powerful risk management tool can drive continuous improvement in product and process quality.

Lack of Appropriate Documentation

Documentation is one of the commonly ignored yet significant processes. There are still many manufacturers who prefer paper-based documentation systems that hold them back in the era of digital transformation. Even the ISO recommends the use of digitized documents and electronic signatures.

Manufacturers need to adopt an electronic document management system to store, manage, and share the controlled documents securely. There are some document management systems like Qualityze that come with role-based access to ensure that only authorized can access and retrieve the documents.

An electronic system will help maintain an appropriate log of documentation including the different versions that get created over time.

Lack of Balance in Continual Improvement Activities

Maintaining balance in continual improvement activities often requires manufacturers to perform regular audits that help them to identify new improvement opportunities. An audit management system in place will help manufacturers to establish a consistency of process and product improvements.

Audit software enables organizations to scheduling audits and their follow-ups well-in-advanced to not to miss any deadline. So, manufacturers can rely on audit management software for managing end-to-end audit processes without any hassles and strike the balance in continual improvement activities.

Regular Audits = Regular Improvements (or Continual Improvements)

What if all these challenges can be managed easily with a single solution? Yes, just one solution and you are sorted. All you need to do is invest in a powerful Enterprise Quality Management System like Qualityze. It will help you standardize, streamline, and support all your quality management processes with its high-end built-in capabilities.

Qualityze is an EQMS suite that comprises eight different solutions including Nonconformance Management, CAPA Management, Document Management, Change Management, Audit Management, Supplier Quality Management, Training Management, and Complaints Management to enable your quality teams managing the end-to-end quality processes from anywhere around the globe.

Since the era of digitization demands for a flexible, scalable, reliable, and secure solution, Qualityze eQMS makes a perfect choice for the manufacturing companies to cope up with all the demands.

Why follow words when you can experience Qualityze difference anytime, anywhere by requesting a free demo today? Get in touch with our customer success team at 1-877-207-8616 or write to us at info@qualityze.com and we will be right there for you.

The increased emphasis on “Quality” has made it mandatory for organizations to have a structured, streamlined, and standardized quality management system that can help them manage all the quality processes while mitigating operational risks. However, not every quality management solution is suitable for achieving total quality management and business objectives.

What? Aren’t quality management solutions and total quality management the same? Many of you might be wondering that, right.

Well, they are not the same. There are some fine differences between the two that you need to understand. Only then you will be able to choose appropriate tools and solutions to drive the cycle of continuous improvement.

Let’s quickly have a look at the definitions of Quality Management System and Total Quality Management

Quality Management System

It refers to the collection of business processes, policies, and procedures to ensure that the organization is meeting all the customer and compliance requirements. achieving the ultimate goal of customer satisfaction. The quality system guides an organization the right way to achieve, manage, and maintain the quality expectations set by customers and the regulatory standards.

QMS is a must for every organization since it serves as a tool for your quality team to drive the quality improvements smoothly.

Total Quality Management

It refers to the well-defined approach towards organizational productivity and development. It focusses on improving the quality of organizational deliverables – be it goods and services while maintaining the cycle of continual improvement for the internal processes. A total quality management approach covers internal priorities as well as statuary requirements.

Industries Using Total Quality Management

Initially introduced for the manufacturing industries, total quality management has proven its potential for different industries nowadays including pharmaceuticals, life sciences, etc. since it focuses on comprehensive change.

The total quality management approach is not suitable for organization-level processes, but also the department level processes as well. Such an aligned approach helps to ensure that the entire organization is making efforts in the direction of goals, continuously improving the functions and workflows in each area.

However, implementing the TQM approach couldn’t be possible without an effective QMS. It won’t be wrong to say that the Quality Management System is a much-needed tool to ensure total quality management in an organization.

How QMS Helps Achieving TQM?

TQM is all about the involvement of all the employees working at the different levels to contribute to achieving business objectives including customer satisfaction. We will now look at the components of total quality management and how QMS helps to manage them.

Meeting Customer’s Quality Requirements

Since the idea of total quality management revolves around customer satisfaction, a powerful quality management system helps an organization to communicate the customer and compliance requirements to their employees. This ensures that the entire organization is working towards a common goal of customer satisfaction.

Additionally, a QMS can help to identify the right training needs, reestablish the existing processes, implement newly introduced standards to achieve customer satisfaction through quality products.

Focusing on Organizational Effectiveness

Though total quality management looks at the bigger picture for quality improvements, it needs consistency of quality processes to maintain customer satisfaction. You can maintain that consistency by using the right quality management software solution to streamline and standardize the quality processes.

A QMS can also help you manage the continual improvement cycle while keeping all the processes in a consistent workflow.

Process Improvement

In total quality management, the focus is on improving the quality of the processes. Instead of making only staff accountable, the organization can change the existing processes to produce an improved product. A comprehensive quality management solution not only helps to streamline and to improve the existing processes but also guides through the change management process.

A good QMS makes organization change-friendly especially when a change could mean a world of difference in product quality.

Employee Involvement

The total quality management approach is not about keeping employees under unnecessary pressure to get the work done, it is more about giving them opportunities to improve. For example- you can identify the right training programs to enhance your employee competency. A full-fledged QMS can help you manage training needs as well.

Also, their contribution should be appreciated regularly to maintain a culture of quality.

Making Quality Everyone’s Responsibility

For total quality management, everyone in the organization is held liable to maintain quality standards to meet customer’s as well as compliance requirements. A QMS plays a key role here since it helps to establish a compliant system for quality checks and assurance. You can also perform validation and verification through the approval feature of a QMS.

Hence, a quality management solution helps to make the quality of everyone’s responsibility.

Fact-Based Decision Making

When we talk about total quality management, it is very important to take all the data and information into analysis for informed decision-making. This cannot be done using traditional methods. You must have an electronic system to record and analyze all the data and information appropriately to make informed decisions.

Make sure you invest in an Enterprise Quality Management System that can serve all your needs from documentation to fact-based decision making.

Improved Collaboration and Communication

As we have already discussed that total quality management is the outcome of team efforts and quality is everyone’s responsibility, having a fine-tuned communication and collaboration among teams is very critical. A quality management system like Qualityze gives your employees a centralized platform to collaborate and communicate for all the important tasks and decisions.

You can get a cloud-based QMS for added flexibility.

Continuous Improvements

Total quality management focuses on waste reduction and improved efficiency to ensure that a quality product is produced right from the first time. It relies on continuous improvement to ensure a consistent product and process quality while resolving issues, which can be managed using a robust QMS.

Now that you understood how TQM and QMS complement each other for organizational productivity and effectiveness. Be sure that you choose the right quality management software to make the total quality management approach a success for your organization.

Though there are multiple options for quality management solutions to choose from, one of the highly recommended and reputed solutions is Qualityze eQMS. It is the next-generation system software, designed on the most powerful and secure cloud platform Salesforce.com.

Qualityze has an intuitive, configurable interface, to ease the way you manage your quality processes. It adheres to regulatory compliances to ensure the systemic adaptability of industry best practices in the organization. From document control to internal and external audit findings, training programs to customers’ complaints, Qualityze helps to create a centralized, automated system to help you manage every process with ease.

Also, you can leverage built-in capabilities like e-Signature, Configurable Workflows, detail audit Trails, and much more. Experience the difference with Qualityze eQMS today by requesting a free demo!

Any organization to comply with statuary requirements requires a regulated process for document change control especially the ones that belong to the pharmaceutical and medical device industry. These industries need a strategic approach to manage the changes in the controlled documents to ensure that every change made follows cGMP and relevant regulatory standards.

What are Controlled Documents?

Controlled documents are the ones that must undergo a regulated and defined process for review, approval, distribution, modification, storage, access, and even deletion. In simple words, a controlled document undergoes standardized processes to manage change and compliance.

ISO 9001:2015 also requires organizations to manage controlled documents for the effective functioning of the quality management system.

What is Document Change Control?

Document change control is all about establishing a streamlined process for transmitting critical information between the involved parties.

As per ISO, Document Change Control can be referred to as control on:

1. Approval of important documents based on adequacy before issuing them to the relevant parties.
2. Review and document updates as and when required. (It may include reapprovals as well)
3. Changes and revisions status of the controlled documents.
4. Availability of relevant and most recent versions of the documents at the time of use.
5. Legibility of the documents for easy identification.
6. Distribution of the external documents in the organization especially the one that comes from subcontractors or suppliers.
7. Unauthorized use of controlled documents.

However, the control procedures are applicable to documents as well as records. You must be wondering What’s the difference.

Well, documents include Quality manual, Quality procedures, Technical designs and drawings, Presentation, Recipe while records include Training certificates, Audit findings, Feedback questionnaire/survey, Meeting minutes, order receipt, etc.

Some organizations even have the document controllers to classify the specific documents that must be controlled. Their key role is managing the controlled documents using a set of industry best practices and processes.

What Document Change Control Process is Intended for?

Document change control helps organizations to keep consistency, quality, and compliance of the documents in check. A well-established control process helps to reduce the errors in the critical documents and avoid the inconsistent flow of information. This further ensures that the quality quotient of the end-product doesn’t get affected even if the person at duty changes.

Document change control also improves the reliability of a document, ensuring that it has already undergone a regulated process of review and approval. However, you can also prepare a document control checklist to ensure a compliant process.

How to establish a compliant document change control process?

The conventional change control processes may not be effective since the organizations are shifting to digital documentation. The best way to manage the new-age trend of digitized documents is an electronic document and change control management system.

Most of the document change control management solutions are designed to comply with FDA 21 CFR Part 11 quality standards for documentation including Electronic Signatures and comprehensive Audit Trails.

How a Document Change Control Software can help?

Investing in a specialized document change control management software can help you align the controlled document changes and upgrades with the quality objectives through:

Initiation and Documentation of Change

When you have a document change control management software in place, you can initiate and document the change requests systematically. It enables you to store every important information about the change request made including the date, type, justification, priority, the owner of the request and much more.

Documenting the details about change requests can serve as an easy reference for the future if the same request is investigated. It can be a source of evidence too to make informed business decisions.

Effective Review & Approval of Change

The change request cannot be processed until it is reviewed thoroughly and approved by the management. A change control software can help you perform different types of reviews including management review and analyze those review results before you approve any change request.

Reviewing and approving a change in the controlled documents is a critical function to be performed and requires utmost precision and accuracy that you can ensure with a change management software system.

Notification of Change to the Impacted Users

In addition to documentation, review, and approval of a change request, a change control management software solution also helps you to notify the change to the impacted users. It gives them enough time to identify best practices to implement the document change within the specified time without any hassles.

A software can help you inform all the impacted users at the same time to ensure no harm to the on-going processes and productivity of your team. This makes your team ready for the change and organizes their workflows accordingly.

Implementation of the Change

Keeping your quality teams and processes informed and aligned with the upcoming changes helps to reduce the change implementation cycle time significantly. A document change software also enables you to configure the workflows based on best practices of change implementation.

An effective software helps to track and to manage end-to-end change processes for multiple change requests at a time that cannot be efficiently done through manual practices of change management and implementation.

Automatic Creation, Revision, Expiration, and Archival of your Controlled Documents

Version control and archival of the controlled documents is one of the critical functions to be taken care of during the change management process, which may turn tedious with the traditional paper-based management systems. On the other hand, change management and control software can help you manage all the activities including automatic creation, revision control, expiration, and archival of your controlled documents.

A software helps you to ensure that your quality teams refer to the most recent version of the controlled documents by keeping control of revisions.

Ensuring Regulatory Compliance

The advanced document change control solutions are designed to comply with FDA 21 CFR Part 11 quality standards for documentation so that the organizations can leverage the electronic signature and audit trail. This ensures that only validated and verified information is circulated through the organization.

Hence, using software ensures regulatory compliance for your document change control processes.

A powerful change management software solution also gives you greater visibility into your change processes and reinforces benefits like:

• Reducing the time to implement a Change
• Getting Better Understanding of Growing Customer Needs
• Establishing Best Practices to Achieve Business Goals
• Defining Operational Workflows to meet Industry Regulations
• Attaining Excellence in Business Performance

Wouldn’t you like to standardize the change management processes across the organization to improve your product and quality processes?

So, get an effective change management software like Qualityze today. You can test its functionalities for free by requesting a free demo.

The cherry on the top: You will also get the 1-week product trial for free.

Audit Management Systems are vital for organizations to maintain a culture of continuous improvement while achieving business objectives. There has been a recent upgrade made to the International Standards for Auditing Management Systems to help organizations maintain a competitive edge in the marketplace.

The most recent version released in July announces the guidelines for all the aspects of the audit management systems from the basic principles of audit, audit management program, performing audits and managing the audit findings while setting out the guidelines for evaluation of the competency level for the people involved in the entire audit process.

There is an increased emphasis on risk-based audit processes in the new revision of auditing principles to drive continuous improvement more effectively. The new principles also talk about harmonizing the multiple systems available in a place with a standardized approach for the entire auditing process.

The current revision of the standard demonstrates the increasing number of standards for management systems include the recent revisions of commonly used standards such as ISO 9001 and ISO 14001. However, the new revision is still under the Committee Draft (CD) stage that gives all the countries involved freedom to comment on their opinions for the draft before it finally gets published.

“When the standard was last published in 2011, there were 11 management system standards, but that number has since grown significantly to 39, with 12 others in development.” Says Denise Robitaille, Chair of ISO/PC 302, the ISO project committee responsible for the revision. Reference link

This revision is intended to serve the needs of sector-specific standards for different organizations. Since one can easily find the management standards covering different aspects including environment, services, health and medical, information technology and more, there is a need for robust auditing processes for these systems to reflect the effectiveness of new standards being developed.

ISO 19011 is meant for all the organizations that need to conduct internal or external audits of a quality management systems they are using. It is suitable for a broad range of potential users, including auditors. If you are also implementing quality management system, you will have to conduct audits of management systems for regulatory and compliance purposes.

ISO 19011 also includes the guidelines to conduct the external audits, for certification and supplier quality check, to support the implementation of quality management systems. These guidelines are based on seven basic principles.

Principles of Auditing

The auditing of management systems is based on seven fundamental principles that make an audit management system effective tool to support the quality processes, controls, and policies. It guides the organization with critical information to act upon and improve its overall performance. Following these principles enable auditors to work independently since they can get more relevant audit findings.

The seven principles are briefly explained below:

Integrity

It is also referred to as the foundation of professionalism for auditors as well as the individuals involved in the audit program. They should perform all their duties with proper ethics, responsibility, and honesty. They should perform the audit activities for which they feel competent. Most importantly, they need to be unbiased in all their dealings and should be influenced while making any final call of judgment.

Fair Presentation

Auditors need to demonstrate all the audit activities and materials including reports, findings, and conclusions accurately. They should report every major and minor obstacle they experienced during the audit even if it is a difference of opinions between him/her and the audit team. The clear, timely, and truthful communication is the key to the successful auditing of the management system.

Due Professionalism

Auditors should exercise due care for the tasks they are performing since the audit clients and the other involved parties have shown trust and confidence in them. They should not compromise on professionalism when it comes to making judgments in different audit activities. The more they will exercise due professionalism, the more reasonable judgements they will be able to make.

Confidentiality

It might sound very cliché when we talk about the security of information, but it’s quite critical to care for. Auditors should, at not condition, disclose the information related to their duties including the errors and findings they encountered inappropriately for the personal gains. This is applicable to the audit client as well. All the information regarding auditee should be wisely handled as per the clause of confidential information that will remain between only among trusted parties for the safeguard of business.

No Dependency

Auditors need not involve any bias influences or conflicts when it comes to the audit activity. They should maintain the dependency only on the audit findings and conclusions to make a fair report. It is as important for small organizations as large to make a sincere effort to keep no bias and encourage fair audits for fair improvements.

Evidence-Based Approach

Auditors, to make their audit activity reliable, should make appropriate use of evidence. They should develop that habit of collecting evidence since an audit is conducted on limited resources for a limited time. Keeping the evidences for all the audit activities helps auditors to keep the confidence of audit clients in whatever conclusions they suggest.

Risk-Based Approach

Any audit activity should be performed only after considering all the potential risks and opportunities. Such an approach could bring a difference in all the activities from planning till the execution and reporting of events. Auditors can achieve the audit program objectives more efficiently with a risk-based approach since it can bring their focus on new opportunities.

These were just a few updates from the recent version of auditing standards.

The best part is Qualityze Audit Management System can stand the test of time and evolving standards without any difficulties. You can perform all your audit processes efficiently that require an ample amount of time in planning and executing the audit activities such as creating checklists, managing audit findings, and reducing audit cycle time and costs while fostering continuous improvement.

So, if you also want to standardize the audit management system across your organization to make the most of your audit findings, get Qualityze today to streamline your audit processes cycle the smart way!