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Quality event management systems (QEM systems) are essential to ensure that products coming out of your facility are safe and effective, and they also help you identify opportunities for improvement. However, many companies mistake these systems for purely paperwork exercises. In reality, QEM is a data-driven approach that utilizes statistical analysis to understand what works in your manufacturing processes and what doesn’t—all while keeping an eye on critical quality issues such as CAPA (corrective and preventive actions).

Quality event management system (QEM Systems)

Quality event management systems (QEM systems) help companies manage quality events. They’re an important part of the corrective and preventive actions (CAPA) process, contributing to an organization’s ability to identify and reduce risk. A CAPA approach involves identifying the root cause of problems through a systematic analysis, taking action based on that analysis, then evaluating whether those actions were effective.

From this perspective, it can be helpful to think about QEM systems as the “cause” in a CAPA framework: they allow you not just to track and document your quality issues after they happen but also provide tools for analyzing them in order to prevent similar issues from occurring again in future products or services.

capa-v1

Qualification and validation

If you’re in charge of a company that needs to comply with regulations, then you’ll want to make sure that your quality event management system is up to snuff. QEM systems are an essential part of any CAPA plan and help you track your products from beginning to end. If a quality event occurs, you can use the QEM system’s reporting tools to collect information about it and determine how best to correct or prevent it from happening again.

It may seem intimidating at first but once you organize all your documentation, there are many benefits that come along with using a CAPA plan:

How does CAPA connect to QEM systems?

CAPA is a system for managing the process of identifying, evaluating, and correcting problems in a product or process. It’s a key part of quality management systems and is not a one-and-done process. You can’t just fix your issues once and then walk away feeling satisfied with yourself. CAPA is an ongoing effort to continuously improve your organization’s performance, quality, and safety. To keep those improvements happening, you need to keep improving your QMS as well!

Not a one-and-done process

CAPA is a continual process and not a one-and-done process. In other words, it’s not about fixing an issue once and then moving on to the next thing. Instead, it’s about identifying problems in your business so that you can fix them before they become bigger problems.

It’s also important to remember that CAPAs don’t just happen during a crisis. They’re something that should be done at regular intervals (like every quarter) so that you can identify potential issues before they become full-blown problems.

QEM systems can greatly streamline the CAPA processes

Quality event management systems (QEM systems) are used to manage quality events, which are issues that occur at any point in the production process. The CAPA process is a way of identifying, analyzing, and fixing problems. Once a problem has been identified and fixed, it can be determined whether to continue using the same method or change course completely by implementing corrective actions.

This process creates a culture of quality where employees know that the management respects, appreciates, and values their work. This helps prevent future errors from occurring because employees take pride in their work and want to do everything possible not only for their own benefit but also for the good of their organization as well as those around them who may rely on its services or products down the road.

Conclusion

These terms may seem complicated, but they’re just a part of any good QEM system. By creating a quality event management system that incorporates CAPA and qualification and validation, you can streamline your process for managing errors and mistakes at events. You can also reduce the risks that these errors might cause by using CAPA to prevent them from happening in the first place. While these systems are not perfect—they do take time to implement—they offer an extremely valuable service if used correctly.

 

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What is Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR)?

If you are wondering why you need Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) and how it helps, this is the article you want to read.

Getting IATF 16949 certification is not easy. Especially when you are new to the business and don’t even have ISO 9001:2015. As per the standard process, suppliers have to meet IATF 16949:2016 requirements in order to register. For small companies (low-tier suppliers) that don’t have that much time or resources, it becomes a bottleneck. Also remember IATF 16949:2016 is not a standalone quality management standard, therefore the supplier will have to meet ISO 9001:2015 too.

That is where Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) comes into the picture. MAQMSR is an interim step towards IATF 16949:2016 certification but with MAQMSR the supplier can register. So The supplier will eventually need to meet IATF 16949:2016 requirements anyway but while meeting that, the supplier will be able to register too. The entire requirement can be seen here as published by IATF.

What are the steps of IATF 16949:2016 with the interim step of Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR)?

There are mainly four steps, which are

  1. ISO 9001:2015 certification through 3rd party audits – If you already have ISO 9001:2015 certification, you can skip this step, or else you will have to meet this. We recommend using quality management software for this which will make your process a lot smoother and more efficient. For e.g. you might need to show your audit trail, with a QMS in place, it’s just a click away. If you think you can’t bear the cost, a QMS doesn’t cost much considering the value it brings. For e.g. Isolocity QMS costs only $199/month/admin user and if you want to add a production user, you just have to pay another $29/production user/month. That’s it, no activation fee, no SOP fee, no training fee, and no hidden fee. Talk to us to know more.
  2. ISO 9001:2015 certification + compliance to Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers through 2nd party audits – If you manage to clear this step, you will be able to register. It works on the principles of ISO 9001:2015 itself and 46 clauses and sub-clauses. All details can be found here.
  3. ISO 9001:2015 certification + compliance to IATF 16949® through 2nd party audits – This is the initiation of  IATF certification. Isolocity can help you here too as our software is IATF 16949 compliant.
  4. IATF 16949® certification through third-party audits with a Certification Body – This is the final step towards IATF certification. For the third-party audit, you need to make sure you have a document management system in place, make sure your system is effective, and follow all the processes with the proper control measures.

ISO 9001 vs MAQMSR vs IATF 6949 Clauses

Though MAQMSR and IATF are developed on the fundamentals of ISO 9001:2015, they all have their individual clauses which are to be fulfilled. ISO 9001:2015 has around 66 clauses and sub-clauses where as MAQMSR has another 46 clauses and subclasses. For IATF the number of clauses are 107 including clauses for MAQMSR.

Minimum-Automotive-Quality-Management-System-Requirements-for-Sub-Tier-Suppliers(MAQMSR)-vs-IATF-vs-ISO-9001

Conclusion

Before you start planning for your MAQMSR, you should always ask your customer and only proceed if they nod. If you need any help, feel free to get in touch with us. For more clarity on pricing, check our dynamic calculator.

Snapshot of MJBizCon 2022

If you are a cannabis industry enthusiast, you would know about MJBizCon, one of the largest (and oldest too) cannabis business tradeshows in the world. The economic turmoil in the USA and the world could not stop 1400+ exhibitors from attending the MJBizCon 2022 in Las Vegas. When they entered the tradeshow, they were up for a shock as they had never seen such a big expo in the 11-year history of MJBizcon, spanning 280,000 square feet on two floors in Las Vegas Convention Center’s South Hall.

MJBizCon 2022 Highlights

This year we have seen many ups and downs in the cannabis industry. For e.g. New countries like Germany entering the legalization process of medical and recreational cannabis is a major event. Similarly, New York giving adult-use conditional cannabis licenses to cultivators, processors, and retailers is also a positive move. In contrast, the drop in wholesale cannabis prices has impacted the cannabis industry. As a result, like other industries, we have also observed many cannabis companies implementing cost-cutting measures.

In a time like this, MJBizCon is definitely a breath of fresh air. Moreover from a business perspective, setting up international trade partnerships is the foundation of scaling up a business, which is why businesses from across the world attended MJBizCon 2022.

This year Isolocity was fortunate enough to participate in MJBizCon 2022 tradeshow. In brief, MJBizCon 2022  was an action-packed event for Isolocity.

The floor space was mainly divided into four parts,

  1. Cultivators
  2. Processors, Labs, and distributors
  3. Retailers
  4. Other business services

Many speakers delivered interesting talks about various aspects of the cannabis industry. But Dr. Bernhard Babel’s talk on German Legalization was enlightening and stood out. He provided some insights on what the German producers are preparing for with the pending recreational market.

MJBiz CEO Chris Walsh talk on “State of the Industry and Predictions for 2023” was also intriguing. Chris warned about the possible growth of the New York illicit cannabis market after the Adult-use cannabis launch. He also touched on the topic of Canadian cannabis and said that the Canadian cannabis inventory will see a spike in 2023 but might fall in 2024.

MJBizCon 2022 – Isolocity Highlights

We were excited to meet some of our existing clients, partners, and friends. First, we met our client Xtra Labs, who recently achieved ISO 9001 certification using Isolocity.

The first annual partner meeting by Elevated Signals was fun where industry experts exchanged ideas on the evolution of the cannabis industry.

Elevated-Signals-AGM

Isolocity sponsored a great event at Top Golf with our partners over at ATG Pharma. During this event, we were reminded that like quality standards, safety standards exist for very specific reasons.

TopGolf

It was a pleasure to meet some of our Australian clients in person for the first time. Big congratulations to Green Farmers on their acquisition of Apollogreen.

Green-Farmers

Look out for our MJBizCon interview with Dutchie where we discussed our integration with their track and trace system – those slippers are like gold at the end of a busy week!

The week was topped off with a great dinner with ASTM, a group full of compliance enthusiasts.

ASTM-Dinner

We loved every bit of MJBizCon 2022, especially meeting clients and partners face to face is always nice. We look forward to another productive MJBizCon next year.

 

 

Quality management systems (QMS) and manufacturing execution systems (MES) are often used together in an effort to improve efficiency, productivity, & quality. While these two systems serve very different purposes, they can be integrated to improve outcomes even more. Today we’ll explore the differences between QMS and MES as well as how they can be integrated for better results.

MES vs QMS –  first difference is what they measure

It’s important to note that the first difference between QMS and MES is what they measure. The term “quality” is all about planning, while “performance” is about doing. A QMS focuses on establishing a large, enterprise-wide system that manages quality in accordance with a company’s standards. But an MES focuses on implementing systems that provide real-time reporting and production data.

MES works closely with its counterpart, but it doesn’t need to be as complex because it doesn’t have the same scope of responsibility. Instead of managing an entire company’s quality assurance efforts across multiple departments and locations, it simply provides insight into how individual employees are performing on their jobs today. When used together—MES feeding data into the larger picture represented by QMS—both systems can create a clear picture of overall performance at any given time.

 

MES-QMS

Image source: Elevated Signals

QMS focuses on the processes of a business while MES focuses on what’s happening at the shop floor level

In a nutshell, quality management systems (QMS) focus on the processes of a business. This is not to be confused with quality control (QC), which is an important part of both MES and QMS.

MES, on the other hand, focuses on what’s happening at the shop floor level. It records every detail that happens in manufacturing and tracks its progress through production lines to ensure consistency and accuracy across an entire operation.

QMS focuses on planning, while MES focuses on doing

QMS, or quality management system, focuses on the overall system. It’s an overarching method that takes into account all of the steps involved in manufacturing a product. MES, or manufacturing execution systems, is more granular and specific to the individual processes within your company.

The main difference between QMS and MES is that one focuses on planning and the other focuses on doing. If you want to know what needs to be done for quality control standards across multiple departments during production, then QMS is for you. For example, if your company produces tires for cars but has no way of tracking whether they’re being made safely or efficiently enough (or at all), then implementing a QMS would allow employees throughout each step of production.

QMS are large, enterprise systems that help ensure consistency and accuracy across an entire operation

A QMS is a collection of policies, procedures, and practices that help an organization achieve its quality objectives. A QMS can be applied to any process or product, from the manufacturing floor to customer service.

In a sense, it’s a framework for integrating all your quality activities into one cohesive program. It also ensures consistency throughout your operation as well as accuracy in all aspects of your business—from design to production to delivery.

While there are many aspects of an effective QMS, some key components include:

  • A clear mission statement describing the purpose of the company;
  • A set of objectives describing what you hope to achieve;
  • A set of performance standards against which you will measure success;
  • An overview of how your company intends on achieving these goals;

MES focuses on specific issues or problems in order to improve processes for better outcomes and results

  • MES is a tool for improving processes.
  • MES focuses on specific issues or problems in order to improve processes for better outcomes and results.
  • MES can be used to solve problems, improve quality, reduce costs, reduce waste and increase efficiency.

Integrating these two systems can improve productivity and quality

Integrating these two systems can help improve productivity and quality.

In order to integrate MES and QMS, you will need to:

  • Map the systems together so that they work together seamlessly. This means that every piece of data that is collected in one system is also accessible by the other system.
  • Use automation tools to make sure all the processes run smoothly, even when you have multiple shifts or locations working at once (and often with different teams).
  • Choose software designed specifically for your needs so that it’s easier to use and understand—and less likely to cause confusion or frustration among employees who are using it every day on the job site!

Isolocity QMS has integration with Elevated Signals, an MES platform. Therefore the data can easily flow between these two platforms. Check this article for more information on this – Isolocity and Elevated Signals Integration.

Conclusion

There are plenty of benefits to integrating these systems. Not only will you get a more accurate picture of what’s happening in your plants, but also have the ability to provide better feedback to workers and managers. This can help them make better decisions going forward so that they can do their jobs more efficiently or even automate processes that have been manual up until now!

Quality management architecture (QMA) is the way you organize your quality management system. QMA helps you to gain better control over your processes and to identify areas for improvement. This article provides a complete guide to quality management architectures, covering their purpose, characteristics, levels, and content.

Purpose of quality management architecture (QMA)

Quality management architecture (QMA) is a way to organize your quality management system. It provides a framework for organizing your quality management system and making sure that you are doing the right things at the right time, in the right order, with minimal rework and waste. QMA can be used both to develop new products or services and to improve existing ones.

Characteristics of quality management architecture

Quality management architecture (QMA) is a structured approach to designing, implementing, and managing a quality management system. It’s not the same as quality assurance or quality control – it’s a way of organizing your QMS so you can gain better control over both the process and results of your projects.

QMA is an architecture, not a process or procedure; it looks at how all aspects of your QMS interact with each other in order to deliver consistent results every time.

The levels in quality management architecture

The quality management architecture is a way to organize your quality management system to gain better control. It’s not just a series of tools, it’s a structured approach that provides you with clear direction and helps you make important decisions.

The levels in QMA include:

Level 1:

Awareness of the need for quality. This level involves understanding why quality management is important and what it means for your organization.

At this level, you will also have to finalize all the stakeholders relevant to quality management including the leadership team, managers, and executives. You also need to finalize the related processes, i.e. processes that will impact the quality of the end product. At this stage, you also need to figure out related compliance, i.e. ISO 9001. 

Level 2:

Basic elements of quality management are in place but they aren’t integrated into broader processes or activities within the organization yet. At this level, you should have defined goals and objectives, and key performance indicators (KPIs) that will help measure progress toward these goals.

Assign responsibilities for each stakeholder for carrying out actions on behalf of these KPIs—and then put all these things into writing so everyone knows what needs doing!  You also have to decide code of conduct for the quality management process.

After freeing all these details, you will be able to narrow down the scope of the quality management process. One of the common mistakes most people do, they keep all this information in a decentralized fashion. All these details should be documented properly and should be kept in a central repository. 

Level 3:

This is the last leg of the quality management architecture. At this level, you will have to detail everything.

So starting from routine services and projects (training,  quality planning, etc) to records and reports (Inspection reports, Audit records), compliance requirements (what are the requirements as per ISO 9001:2015, FDA, etc) to the analysis of the economical aspect (what will be the cost of a QMS, the penalty of any failure, etc), you will have to detail out everything.

Once all these are done, we would encourage you to go for quality management software. There are many companies that manage quality management manually, but we recommend software. If you think of the long run (which as a business you should), this will help you save a lot of money. And the last step of level 3 would be going live. 

Quality-management-architecture (QMA)

 

Quality management architecture is a way to organize your quality management system to gain better control.

Quality management architecture (QMA) is a way of organizing your quality management system to gain better control. You can use it to:

  • Create a shared language for quality assurance throughout your organization. This helps people communicate about their work and will make it easier for everyone to understand the purpose of each step in the process.
  • Identify gaps in your current culture and make improvements as needed. For example, if your team has trouble communicating with each other or working together, QMA requires you all to sit down together regularly so that these issues can be addressed early on before they become bigger problems later down the line.

Conclusion

There are many ways to organize a quality management system. Some organizations choose to use the quality management architecture model and others choose another model. The important thing is that you find the model that works best for your organization and then commit yourself to use it consistently in all aspects of your business. If you do this, then you will be able to improve the quality of your products or services while reducing waste and costs at the same time!

Questions? Feel free to reach out to us.

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Quality management solution is critical to the success of any business. It helps ensure compliance with industry regulations and standards, reduces costs, minimizes risks, and increases revenue. There are many different types of quality management solutions available in the market that can help you automate your quality management processes.  So you can become more efficient while still maintaining compliance standards according to ISO 9001 guidelines.

To improve your quality management process and ensure ISO 9001 compliance, it’s important to consider some critical factors when choosing the right solution for your business. Working in a highly regulated environment often means that you have to maintain strict quality management procedures. At the same time, because you are running a business, you would have to consider various other factors too.

In this article, we will only be talking about factors that are measurable. This guide is built on the hypothesis that you would be doing your due diligence before finalizing your quality management solution vendor, i.e. checking their reputations, ratings, and reviews.

1. Scalable enterprise-level quality management solutions

At the time of getting a quality management solution vendor, keep a vision for at least 5 years and see if the solution is flexible enough to scale it to that length. Some of the questions you would want to ask are,

  • Pricing – If your company or team grows by 10% YoY, what would be the additional recurring cost? Some quality management solutions keep their entry cost at a lower level but as you move along, it gets costlier. So you would want to know all the hidden costs/variable costs as you grow and scale. For e.g. at Isolocity as you increase the number of users, the solution actually gets more affordable. With 2 admin users, we charge $199/month but as you add one more admin user, the cost goes down to $184/month. As you keep adding admin users, the cost gets reduced and for 30 or more admin users, we charge only $117/month instead of $199/month. For 30 admin users, that’s a massive saving of almost $30,000 in a year.
  • Integrations – As you grow, you would be using an increasing number of tools and therefore integrations become an important factor. You would want to choose a quality management solution that offers such integrations, which should ideally come with an open API too. At Isolocity, we integrate with a lot of tools and we also provide an open API.

2. Offerings and features should be the end of the story without any bias

  • Offerings – You should not consider an electronic quality management solution if you are only looking for an online repository. The electronic quality management solution should come up with a good UI, have all the necessary modules of a standard QMS, should have a nice reporting mechanism, should help you automate all the tasks that involve labor. Unless you have experienced these elements, you would never know what you are missing. For e.g. instead of doing equipment maintenance manually, you can set up your equipment and add any applicable templates, and then on the due date, the owner will automatically have an action item in their database which opens an inspection.
  • Bias – So at the time of choosing an electronic quality management solution, try and understand all the advanced level features they have which can be used by your organization and then don’t compare those features with your current process, rather compare those features with another electronic quality management solution without any bias (brand name bias, somebody I know from the company bias, etc).

3. Compliance and in-house expertise in quality management solutions

  • Compliance – Compliance is another critical factor when choosing your quality management solution. You should know if the solution has been validated by any third party. For e.g. Isolocity is GMP-validated by a third party. You should also know if the software is compliant with CFR Part 11, SOC2, etc.
  • In-house expertise – As you will be using the software on a daily basis, it is important the vendor has some in-house experts who can help you when needed. Ideally, your quality management solution vendor should have an in-house expert trained in compliance with quality and is aware of the standard being employed. For e.g. Isolocity has in-house GMP and ISO 9001 experts.

Conclusion

Along with all these factors, there might be some other elements specific to your organization or industry. For e.g, if the quality management solution provider has expertise in your industry or has clients similar to your company. But we think the above three factors are the most important and this should give you a direction towards the right course. If you need any help, feel free to reach out to us.

Introduction

How to prepare employees for ISO audit is the most common question we come across. The ISO audit is a critical part of your business’s international standards strategy. It’s an opportunity for your organization to demonstrate that it meets the requirements set by the International Organization for Standardization (ISO) and other regulatory authorities.

An audit is a process of checking the quality of operations. It focuses on the management system, which is designed to ensure that all activities are performed in accordance with defined standards. This can be applied not only to companies but also to any organization that performs certain tasks or carries out some sort of activity.

When it comes to auditing, there are two main types: internal and external audits. Internal auditors check whether employees comply with existing regulations and policies within a company by testing them on their knowledge thereof; they also check whether employees have been properly trained for their jobs and if they have sufficient working conditions (i.e., do they work remotely). External auditors set up their own procedures when carrying out an external audit; they look at records left behind by previous employees and make sure those records were completed correctly before being sent away from the office (for example, if an employee checks off “completed” on this form then signs off saying it’s okay).

But preparing employees for this kind of event can be a challenge, especially if many of them have never experienced an audit before. Here are three tips for making sure everyone knows what to expect during an audit:

The right time for an ISO audit 

The question, of how to prepare employees for ISO audit is directly related to the question, of how ready the organization is.

The first step in preparing for an ISO audit is to make sure your company is ready. This includes ensuring that you have the documentation necessary, your employees know what to expect, and they’re properly trained so they can answer questions correctly and in a timely manner.

You should also take into consideration any recent changes or developments at your company that may impact the audit process. For example: if one of your products has recently been recalled due to safety concerns or if you’ve recently implemented new processes or procedures related to product quality management, these details could affect how an auditor assesses risk factors associated with internal controls over financial reporting (ICFR).

In turn, this might require auditors to ask more pointed questions about those topics during the actual audit itself—so it makes sense for employees who work on these issues on a regular basis to be familiar with them ahead of time!

Once everything is ready and everyone knows what’s expected of them during the audit process itself (i.e., when someone from their department will be called on by an auditor), training can begin! 

Employees should know what to expect during an ISO audit

Employees should know what to expect during an ISO audit. The audit team will arrive at a predetermined time, so all employees—including those who were not present at the initial meeting with the auditors—should be prepared to answer questions about their roles and responsibilities, including any new or expanded responsibilities that have taken place since the previous audit.

Employees should also be prepared to provide documents that support their answers during the audit as well as document changes in procedures or policies. They should also be able to discuss how these changes affect areas like quality management, environmental management, and occupational health & safety.

Employees should be able to provide a trail of any changes. This is easier if the company has Quality Management Software that comes with an Audit trail. But if not, employees should have documents that show the trail.

Audit-Trail

 

Employees should also be aware of all the policies related to their work, e.g. the Quality policy. Employees should know the basic elements and should also have clarity on how it is in sync with the operation they are involved with.

Here are some questions which can be asked during an audit;

  1. What is the document control procedure in your area (Related to Document Control)
  2. Show me the action item X and show me if the effectiveness was documented (Related to CAPA)
  3. What are the findings of the last internal audit? Are any of them past the due date?

 

Closing meeting with the audit team

A closing meeting is a review of the audit to ensure that all issues have been addressed and that there’s no need for another meeting with the audit team. It should be held within 24 hours of the end of an audit, or as soon as possible afterwards.

The team leader should attend, along with other key stakeholders such as representatives from QA, HR and finance. The closing meeting should cover:

  • A summary of what was discussed during each session (reviewing notes if necessary). Any items that were missed can be added to an action plan for future audits.
  • A summary of any changes made after the audit started. These may include new policies or procedures implemented by your company since then – make sure these are included in any documentation provided by your company to customers in case they ask about them later on down the line!
  • An agreement on how long it will take before conducting another ISO certification process

The team leader should be prepared for the closing meeting with all the line items mentioned above.

Conclusion

We hope this article has provided you with some insight into what to expect during an ISO audit. Remember that the most important thing is to have a prepared team that knows all of the right questions to ask and can answer them confidently. If you follow these tips and keep up with your own training programs, then passing an ISO audit should be no problem at all!

Introduction

 

It’s easy to think that document and data control is only important to large businesses, but it’s actually something that every organization should consider. Document and data control procedure involves identifying, storing, maintaining, and disposing of documents in a way that allows you to find them when you need them. It also ensures that everyone has access to the latest version of these important documents. It is also an essential part of good project management and is a common requirement for ISO 9001 certification.

 

Questions to ask for document and data control procedure

 

document-and-data-control-questions

 

A document and data control system ensure that everyone has access to the latest version of important documents.

 

A document and data control system is designed to keep track of changes to important documents and provide access to the latest version. This makes it possible for any member of your organization, regardless of their role or location, to access the same version of a document.

Whether you’re trying to get everyone on the same page about a new product launch or make sure that financial documents are up-to-date before sending them off for auditing purposes, a document control system can help make sure that everyone has access to the most recent versions of critical information at all times.

 

Document-Revision

 

 

Not having a document and data control procedure can be detrimental to projects and businesses.

 

Without adequate document and data control, you run the risk of:

  • losing important documents
  • delivering inaccurate or incomplete information to clients and stakeholders
  • wasting time looking for documents that should be easily accessible

As Isolocity is cloud-based software, even if you delete your document from your personal system, you can access the same from our cloud. In case you commit a mistake and delete the file from the software as well, don’t worry, we keep a backup for that as well.

 

document-backup

Without the right systems in place to handle documents and data, it can be difficult to keep track of changes.

 

Document and data control are essential for business success. Without the right systems in place to handle documents, it can be difficult to keep track of changes or ensure that you have the latest version of important documents.

When you have good document control, you’re able to:

  • Know who has access to what files, when they were last accessed and by whom (if applicable). This helps keep your company secure by ensuring nothing sensitive is shared unnecessarily.
  • Know where all versions of a file are kept, who has them, and whether they are up-to-date with the latest changes (if applicable). This keeps your team focused on what’s important – saving time trying to figure out which version of a file is current.

document-and-data-control-approval

Using cloud-based software allows you to collaborate with others

 

Cloud-based software has become a popular option for document and data control because it allows you to collaborate with others. The ability to store, share and access documents from anywhere is just one of the many advantages of cloud computing.

Here are some more benefits:

  • You can save money on hardware by using cloud-based solutions instead of purchasing new servers or extra storage devices for your office space.
  • Because this type of software keeps all files in one place, you’ll have fewer duplicate copies floating around your company – saving time as well as storage space!

If you don’t have document control in place, it’s time to start.

 

You may not think of document control as a priority for your business. Or, you might know it’s important but don’t have a system in place to manage documents. Either way, it’s time to start!

Document control is an essential part of any business’s operations and will help you meet ISO 9001 requirements, so if that’s something that interests you or your company, then read on for more information about how document control software can help your company keep track of changes made during the course of day-to-day operations.

The first step towards implementing document control is choosing the right cloud-based software. This type of program provides several features including:

  • Track changes made to documents by employees (or departments) at any point in time;
  • Assign tasks such as approval signatures or file storage locations;
  • Verify whether all required approvals have been received prior to submitting documents for printing/copying/faxing;

 

Conclusion

 

Document and data control is a vital part of running a successful business. If you’re not sure where to start, we can help. Our cloud-based software helps you manage your documents effectively so that everyone has access to the latest version of important documents at all times. It also allows users to collaborate on projects and tasks—and it works with any device! Whether you need help managing your documents or just want someone else to handle them for you, we offer flexible solutions that fit your needs perfectly. Contact us today if this sounds like something worth exploring further!

 

Introduction

A manager can easily get bogged down in day-to-day operations and lose sight of the big picture. Taking time to plan for QMS training for employees not only benefits all individuals but also strengthens your company culture.

Define the objective of the QMS training for employees 

You should define the objective of your QMS training for employees. In other words, you will need to clearly state why you are conducting training and what are the objectives that it has to achieve. For example:

  • This training is designed to improve employee skill levels in QMS-related areas
  • The outcome of this training is for all employees (including management) to understand how ISO standards affect business performance

Identify the desired outcome

Once you have established the scope of your training program, it’s time to identify the desired outcomes. What is it that you want your employees to know or be able to do?

Once you’ve identified the desired outcome, determine what employees will need to learn in order for them to achieve that outcome. This may involve reviewing existing policies and procedures and making changes accordingly. The next step is deciding who will deliver the training: You or someone else? If another individual will be conducting some or all of your training sessions, then consider how you’ll document that person’s performance as well as how they’ll deliver each part of their presentation (through video recording or written notes). Lastly—and this is most important—be sure not only to consider what methods will be used but also how those methods can best measure success once completed.

If the training will be done through Quality Management Software, like Isolocity, the entire program can be done through the software without any hassle.

adding-a-new-training-program-status-quality-management-software

 

Determine what employees need to learn from the QMS training

The first step in determining whether or not to invest in quality management training for your employees is to determine what they need to learn. What are their objectives? How can you ensure that they meet those objectives? What do the employees themselves think it will take for them to be successful at their jobs, and how can you help them get there?

If you have an employee who is struggling with a particular area of his or her work, you may need to provide some kind of additional training. On the other hand, if every single team member is performing well and meeting expectations, then this may not be necessary at all.

The second step is identifying desired outcomes: What specifically do we want our team members (or employee) to be able to accomplish as a result of receiving this training? Are there any specific tasks we would like them to do differently than before we began offering these lessons? Will this course help our company become more profitable overall by increasing sales or cutting costs? If so, how much money might that mean for us over time if implemented correctly?

Training-Type

Decide who will deliver the QMS training for employees

Training should be delivered by someone who knows the software. Training should be delivered by someone who is not the manager or direct supervisor of the employee receiving training. This makes it easier for an employee to ask questions without feeling as though they are being questioned, or that they need their manager’s permission in order to ask them.

Training should also not be delivered by a direct supervisor because they may seem biased and give information that may not be accurate or useful based on their preferences and prejudices.

If you have Quality Management Software in place, the training module can be automated. The trainer will only have to create the training on the software once and all employees will be able to access the same online, thus saving time for the trainer.

Consider how you will document the QMS training for employees

The purpose of documenting training is to ensure that employees are consistently trained, effectively trained, and successfully trained. There are several ways you can accomplish this:

  • Create a checklist of the skills each employee must demonstrate in order to be considered fully trained
  • Take notes during training sessions (this will help you remember what was said)
  • Create a video recording of classes so that they can be reviewed later

But the best option would be to use software for this. So apart from automating all these aspects, you have broader visibility of the progress as well as future reference.

training-activities-v1

 

Choose a method for presenting the materials

Once you’ve selected the materials you want to use, you’ll need to decide how best to present them. The following methods are commonly used in training:

  • Lectures—A lecture is typically a teacher-led discussion of a subject. It can take many forms, including video lectures and PowerPoint presentations.
  • Discussions—Discussions allow participants to explore and debate topics with each other in small groups or as a whole class.
  • Group Work—Participants work together on an activity designed by the trainer or facilitator. This may include exercises, projects, or simulations that help participants better understand the material being covered in training sessions.
  • Individual Work—Participants complete workbooks or self-directed learning activities during training sessions (typically at their own pace).  This method allows for more flexibility than group work but requires more discipline from participants due to less structure from teachers/trainers

Considering most employees are working remotely now, cloud-based software can be a preferred method for training.

Identify ways to measure the success of the training

The training should also be measurable, in terms of results, time, cost and quality. The first step is to identify the desired outcome (what you want your employees to do differently after they’ve completed the training). For example:

  • Do you want them to improve their customer service?
  • Are you hoping they will be better able to complete work tasks?
  • Do you wish for their safety practices and overall health habits to improve?

Here is the training workflow for Isolocity

  1. Create employee groups
  2. Create training types
  3. Create a training program
  4. Create a training activity
  5. Add employee groups to the training activity

Check out our knowledge base article for all the steps.

Here is the training checklist glossary for Isolocity software

 

Training Checklist Glossary

Form ElementExplanation 
Yes/No This will provide the user with the option to select yes or no to the question provided.
Date Field This will allow the user to select a date.
Checkbox This is a single checkbox where users that users can select
Checkbox Group These are multiple checkboxes that will allow users to check off more than more items.
Radio Group This is a multiple-choice field that will allow users to only select one item.
Rich Text Editor This is a text box.
Select This is a drop-down menu where users can select one item from the list.
Text Field This is a text box.

Differences between departments, teams, and employee groups

 

DepartmentsTeamsEmployee Groups
The manager of the department will be required to sign off on various reports (i.e., CAPA modules) with which the department is associated.Teams can be used if your company has multiple locations.Employee Groups are created based on which employees receive specific training.
Departments can also be selected in an Approval Matrix where the department manager or authorized signers will be responsible for approving that document stage.Each team is like a fresh new database.This allows you to send out training to multiple users at one time.
 Each team will have its own data that is not transferred between teams
The Employee Groups can be assigned in the “Employee Manager.”
One user can be part of multiple teams and can switch between them from the same login.One user can be a part of multiple employee groups.

Conclusion

Your employees are an important part of your business. They need to know how to use the right tools and how they can contribute to your overall success. We hope this section was helpful in teaching you how to do QMS training for employees. If you want to know more about Isolocity’s training module, get in touch with us for a free demo. 

 

We are one of the top-rated Quality Management Software on Capterra. rate us here.

Introduction

When we think of a 21 CFR 820 Nonconforming Product, the first thing that comes to mind is a consumer who has been injured by a defective product. But did you know that many nonconforming products are not defective? The term “nonconformance” refers to any deviation from the requirements of 21 CFR 820.

This means that with every shipment that arrives at your warehouse, there’s a chance it will be rejected because it doesn’t meet your standards or specifications. When this happens, how should you handle these items? How can you ensure they don’t make their way into the marketplace?

What is a 21 CFR 820 Nonconforming Product? 

  • Nonconforming Product: A nonconforming product is any product that is not in compliance with the requirements of the product specification.
  • Defective Product: A defective product is one that was manufactured in a way that violates safety standards or fails to perform its intended purpose.
  • Substandard Product: A substandard product is something that doesn’t meet standard quality levels for its intended use.

Nonconformity can occur during all stages of production: design process; pre-production inspection; production process; post-production inspection; packaging/storage; shipping/delivery; installation

Process flow for 21 CFR 820 Nonconforming Product

21-CFR-820-Nonconforming-Product-Flow

21 CFR 820 Nonconforming Product

What is the classification of a 21 CFR 820 Nonconforming Product?

As with any regulatory term, there are a lot of ways to define a nonconforming product. But the most common one is a categorization based on risk level and how much testing needs to be done before the product can be sold. This classification system is called 21 CFR 820:

  • Class I (lowest risk) – No testing is required

  • Class II – Acceptable reportable products that require no more than visual examination only (e.g., toys)

  • Class III (medium risk) – Acceptable reportable products that require some additional testing or evaluation prior to sale (e.g., detergents)

  • Class IV through X (highest risk) – Highly toxic and carcinogenic substances such as radioactive materials used in medicine or research labs

Who is responsible for disposing and handling nonconforming products?

When it comes to disposing and handling nonconforming products, the manufacturer of the product is responsible for ensuring that it does not cause harm to humans or the environment. The distributor and importer of said product are also responsible for ensuring that no damage occurs.

If you are a manufacturer, distributor, or importer who has been issued with a recall due to a violation of 21 CFR 820, you must ensure that all products within your control are returned to your company for proper disposal. If this cannot be done immediately because there is not enough time before the deadline set by FDA, you may request an extension from federal regulators so as not to put consumers at risk unnecessarily.

How should the nonconforming product be segregated?

You should keep the nonconforming product separate from the rest of your products. You can do this by keeping it in a designated area, or by putting it into a designated container that is not used for other products.

When should a nonconforming product be rejected?

As a manufacturer, you must reject a nonconforming product if:

  • It presents a health or safety hazard.
  • It does not meet legal requirements.
  • It violates regulations.
  • It is in violation of contract specifications.

How to handle rejected products to prevent their entry into the market

  • Destroy rejected products.
  • Dispose of rejected products appropriately.
  • Document the disposition of rejected products according to applicable requirements (e.g., Federal Food, Drug, and Cosmetic Act).
  • Segregate rejected products from the nonrejected products until disposal is complete or further processing is required by law or regulation.
  • Track all actions taken with respect to the disposition of a rejected lot as appropriate for your facility (e.g., print labels; place them into shipping containers). Test all remaining inventory against specifications at least annually (or more often if necessary) to ensure that no other subpar lots exist within your inventory system and are not entering into commerce.*

What proactive actions can companies take to address nonconformance?

Let’s look at some examples of what companies can do to address nonconformance.

  • Talk with your customers and ask them what they think your company could be doing better right now, or where they think the biggest problems lie in their experience with your products or services. Use surveys, focus groups, interviews, etc., depending on how large or small of a number of people you want to talk to
  • Look at data from past products/projects and identify trends that suggest there may be issues with quality (e.g., if every product that’s been shipped has been returned due to defects).

3 regulations related to 21 CFR 820.90

  • 21 CFR 820.1: The FDA’s general rules for the regulation of drugs and biological products, including a description of the requirements applicable to each type of product, the conditions under which they may be distributed in interstate commerce, and their labeling.
  • 21 CFR 820.20: General requirements for drug production quality, including procedures to prevent contamination of starting material with microorganisms (including viruses). This also covers environmental monitoring; quality control unit; written standard operating procedures; reporting (including deviation reports); corrective action plans; complaint handling systems; and training records for personnel involved in manufacturing operations.
  • 21 CFR 820.90: Medical devices that are not tested or cleared by the FDA must be labeled with all required information about the device’s performance characteristics or limitations as well as any restrictions on use or warnings about potential adverse events.

Keep in mind that when it comes to 21 CFR 820, your action regarding nonconforming products can impact your company.

Keep in mind that when it comes to 21 CFR 820, your action regarding nonconforming products can impact your company. For example, if you choose to not follow the requirements of 21 CFR 820.100 and a product is recalled as a result of an inspection by FDA or another regulatory agency, you could find yourself facing civil or criminal penalties. It’s important for you to understand what your options are in terms of nonconforming product reporting.

We have also come across this PDF from the FDA website, check this out, it is very helpful.

Conclusion

The bottom line is that when it comes to 21 CFR 820, your actions play an important role in determining the future of your company. If you need help with Nonconforming products, Isolocity can definitely help. Get in touch with us and we will give you a live demo of how our software can help.