Have you ever wondered how some life sciences organizations manage their quality process so well, while others just feel stuck in aligning their processes, right? On top of it, the quality issues in the pipeline are just increasing. 

You are not the only one facing this issue! 

We all want to drive a culture of quality, compliance, and excellence that reflects every product, process, and service. But, most importantly, the customers must have enough confidence in the brand for the product quality and safety to keep coming back and recommending it to others. 

The first step in achieving operational excellence in life sciences is implementing a comprehensive quality management system. 

Why does Lifesciences need a Quality Management System?

A quality management system is essential in defining what quality means to a life science company and aligning it with regulatory requirements and customer demands. 

An organization’s Quality Management System (QMS) helps it achieve compliance and consistently deliver high-quality products. The purpose and goals of an organization should be translated into policies and resources, which encourages all members of the organization to adopt standard operating procedures (SOPs).  

The QMS can help to improve compliance, profitability, and quality culture. However, certain core elements must be present for a life sciences company to reap the benefits of its quality management system truly. The core elements of quality management assist in determining quality objectives, ensuring compliance with all product development steps, and monitoring the opportunities for continuous improvement. 

Life Sciences: Five Considerations for Choosing the Right EQMS

Consider what your organization needs from a Quality Management System (EQMS) to determine which vendor and system are suitable for your organization. During the selection process, consider the following: 

1. Determine what your organization needs from an EQMS 

   It would be best to decide what quality processes you want to manage within the system. For example, would you manage only controlled documents or other critical functions like audits, training, CAPAs, and customer complaints? Starting out, you may only use auditing solutions, but as your business grows, quality management systems mustbe able to provide the support you need. You can make the best decision regarding the type of system you need if you consider all needs for the quality solution. 

2. Engage your employees in quality activities 

   Regardless of how an EQMS is implemented, it is vital to consider the requirements of all departments who will interact with the quality system, as well as your Quality Assurance Group. It is a good idea to create a cross-functional team for evaluating needs to gather all input and requirements from the various business units. You can either manage this in-house or have a third party handle it, but having the right people participate in the discussion early on is crucial. 

3. Make your choice between ready-to-use preconfigured or configurable systems that grow with your business 

   Suppose you want to determine which type of quality management software is the best fit for your organization. In that case, you need to consider two factors: whether your existing processes fit into a preconfigured, out-of-the-box system or a customized system tailored to your organization’s specifications is more suitable. 

   Your budget may be affected after discussing and analyzing the requirements you have. But, sometimes, your budget may also determine what kind of system you choose. 

4. Do not underestimate the budget factor for choosing your EQMS  

   Selecting the right EQMS vendor for your budget can be challenging since many EQMS vendors exist. In cases where budget limitations govern the selection of your EQMS, an off-the-shelf hosted solution might be more practical than implementing an on premise customized QMS. Understanding all company requirements and associated costs is crucial when implementing an off-the-shelf, cloud-based, or on-premises customized solution. The best system is the one that meets your current and future needs. 

5. Make sure you consider the validation process and its costs too 

   Most quality management software vendors provide you with a validation documentation package and template IT SOPs that You will need to use and implement the EQMS. However, vendors may charge additional fees for validation, or you may need to hire a third party. Perhaps this is a hidden cost that you were not aware of earlier. Make sure you know the requirements for having your EQMS system validated and what changes will need to be made. 

Some Other Considerations You Can Have 

In addition to the considerations listed above, you may list the other factors that are important for your organization. For example – you may need an EQMS that facilitates real–time collaboration and communication among teams working worldwide. Or you may need a system that can seamlessly integrate with your existing enterprise quality systems. This is especially important for regulated industries that require complete control on processes and data. 

Bonus Tip: Ask your vendor or quality solution provider if they have ever worked with regulated industries like yours. You will gain a better understanding of their credibility and accountability. You can consider looking at their customer testimonials too. 

After all the evaluation, if they are a great fit for your EQMS requirements, get a free product demo scheduled to experience the functionalities and capabilities in real time. It helps you make an informed purchase decision. 

We do understand the struggle of choosing the right Enterprise Quality Management Software for the Lifesciences industry, especially when the regulatory standards are getting stringent every day. We would like to make things a little easier for you with a quick recommendation. 

Now that you have already decided to upgrade to a next-generation Quality Management Software, you must give Qualityze EQMS Suite a thoughtful consideration. It is a cloud-based, intuitive, and configurable solution to pace up with your growing business needs today and tomorrow. It is built on the most powerful and secure cloud platform, i.e., Salesforce.com. It comes with impressive functionalities and features. You can integrate it with your existing quality systems too.  

You may be compromising the efficiency and effectiveness of your business by not prioritizing comprehensive document version control.

How come?

Version control prevents your employees and decision-makers from acting on outdated, incomplete, and missing information across departments and individuals; and this has substantial financial implications. Unfortunately, this problem is more common in organizations with manual or legacy systems than you might expect.

Effective version control helps maintain document integrity, increase productivity, and make the most of all the available data.

Version control: What does it mean?

Version control involves managing multiple versions of the same document, especially when a clear record needs to be kept of the process by which the document was created, developed, and modified over time. The document gets an identifier each time it is revised, so you can identify the latest version and differentiate it from drafts and final versions.

Version control is useful in a digital collaborative environment, where many people work on developing a document, tracking its changes, capturing decisions, and documenting the review process.

Often, version control is employed when developing essential documents, such as policies, procedures, and strategic plans, since these documents are reviewed and updated frequently, and knowing which version is in force at any given time is essential.

Version control: Why is it important?

Version control identifies the development of a policy, a new procedure, or standard guidelines. It allows you to archive and retains all the versions of the document. For example, the first draft was submitted to a group for comment. The current document that resulted from those comments. The subsequent versions which were passed back and forth for clarification, and the final draft, which was approved by the department head, signed off by the authority of IT is made public. With version control, you can also identify the changes made by different individuals at contrasting times on a document.

Identifying such versions and making them easily accessible facilitates understanding of how the document developed. In addition, it allows a review of previous versions to see when decisions were made regarding content. It is imperative when dealing with controlled documents like work instructions, SOPs, policies, and much more. There is no need to guess what procedure, form, or guidelines are in effect at any time. Older copies can be destroyed to avoid confusion and to save space.

Version control: What are the benefits?

Version control: What are the challenges?

Document version control is not easy to implement only because it has benefits. To effectively implement document version control, many businesses encounter the following roadblocks:

#1: Lack of mobile technology

The ability to control document versions effectively through mobile, multi-site, and remote means is critical to a multi-site operation’s effectiveness. This is more critical in the wake of a recent virus outbreak. Unfortunately, many companies run on systems designed for:

• Lack of device independence
• Lack of integration
• Lack of connectivity to Wi-Fi or the cloud
• Limited to an on-premises installation

Version control and its benefits are ultimately hindered by mobile agility, which is impossible.

#2: Use of outdated legacy systems

The legacy systems in many industries, such as utilities and manufacturing, are disconnected and largely manual. Even though most do not see this as a problem since these are simply “the ways they’ve always done it,” – these legacy systems can pose unique challenges in the era of COVID-19 and the onslaught of data the average business had to deal with in recent years. Furthermore, they can hinder efficient document management.

#3: The lack of standardization of EDMS

A lack of adoption is a significant obstacle to improving document version control – and it is a concern, especially if:

• The EDMS system lacks intuitive functionality.
• The system does not meet the needs of technicians and other users.
• There is a lack of adequate training.
• The system cannot be used on any device.

The lack of adoption of an EDMS system can make it ineffective, resulting in out-of-date, incomplete, and inconsistent documents, which is precisely what EDMS systems are intended to prevent.

#4: Lack of effective Standard Operating Procedures (SOPs).

It would be best if you have clear standard operating procedures (SOPs) that govern your version control practices for document version control to be effective. A consistent approach to information input, approvals, and documentation finalization ensures consistency. Organizations can also gain ISO certification with SOPs.

In most businesses, SOPs do not exist, and workflow processes are not transparent, which leads to inefficiencies and inconsistent results.

Version control: What are the Best-Practices?

Here are some of good practices you can implement to manage document versions:

Hiring an administrator

Maintaining your documents and EDMS system after implementation is made more accessible by an EDMS administrator. They may be responsible for:

• developing documents and keeping them up-to-date
• maintaining an EDMS
• measuring and managing KPIs
• preparing, distributing, and managing data-driven reports
• Training relevant personnel on advanced systems
• Ensuring compliance with regulatory standards

Your organization can also benefit from this person’s expertise by avoiding the mistakes above, saving you money, and improving output.

Maintain the history of documents

You must maintain a clear document history detailing when and who made the changes. Having a versioning capability allows you to know exactly where your document is at any given time and roll back to previous versions if necessary.

Secure your documents

The right electronic document management system allows you to “check out” an electronic document, thereby safeguarding it against further amendments. It protects documents from unauthorized modifications and prevents unnecessary revisions.

Use member controls to restrict changes

The team should have precise controls over who can access and edit and what each member can edit.

Set up workflows to manage document versions

You must create a standardized workflow for managing the different versions of the documents. The workflow also helps automate critical tasks for your team members, such as:

• Watermarking a document to identify its status or version
• Generating a PDF for every new document
• Adding a print stamp when the document is printed
• Electronically signing the document when necessary

This way, organizations can keep their master data current and coordinate their change processes across different work areas. In addition, this validates data and provides a complete audit trail that ensures regulatory compliance.

Make your documents accessible on any device

To make version control work, say goodbye to legacy systems and choose an EDMS like Qualityze that is easy to integrate and can be accessed and edited from a computer, tablet, or smartphone.

Ensure Your Document Security

To ensure your documents are always secure and private, install security features like encryption on your system. In addition, ensure you set up a backup plan, perhaps using the cloud – to avoid data loss.

Integrate with Your Existing IT Ecosystem

You must be able to connect your version control system to existing quality systems so you can gain better control of important documents.

Doesn’t all the activities mentioned above sound like too many administrative duties?

What if we tell you – you can implement all these best practices using a single solution?

That is true!

When you are frequently reported about quality events, and many of them are recurring, it becomes difficult to prioritize them. You may find it challenging to decide which quality events require a detailed investigation. And you end up investing time and resources in the issues that may need minimal attention.  

Okay, so many quality managers say that resolving every issue is critical to achieve product quality, safety, reliability, and compliance. I agree, but is every issue worth the same level of priority?  

Probably, not! 

It is all about their risk severity. If you categorize risks based on severity, you can change the quality management game forever. What I am about to tell you through this post is you can avoid CAPAs piling over and can still achieve compliance excellence with some minor changes in the way you manage CAPAs. 

Quick Read: What is the best way to evaluate and categorize risks? 

As we advance, we look at the key steps to avoid CAPA overload. This makes our compliance journey smooth and more efficient than ever. Even if your compliance journey is different from those of regulated industries, you will still gain valuable insights on best practices to implement and improve the existing CAPA system in your organization. 

What is CAPA? 

CAPA (Corrective Action Preventive Action) is a method of determining and fixing the root cause of the problems. Furthermore, it examines other possible issues and future use and checks the conditions and solutions. 

Good Manufacturing Practice (GMP) and ISO 13485 include Corrective and Preventive Action concepts. Therefore, a CAPA investigates discrepancies methodically to avoid their repetition. 

CAPA is effective only if errors are identified, and their occurrences are continuously investigated. 

What is CAPA Overload? 

An organization or its employees can find themselves in a CAPA overload situation when they have too many CAPA issues in the pipeline and fail to deliver timely solutions for the nonconformances. As a result, your CAPA system don’t function properly despite knowing that these improvements will increase your company’s efficiency and competitiveness. 

9 CAPA Pitfalls You Should Avoid at All Costs 

1. Passing Every Single Issue Through CAPA System

It is a common scenario to witness companies funneling down all the reported events through their CAPA system. But this only leads to CAPA overload, as we discussed earlier. In addition, with the overburdened systems, you find it challenging to prioritize issues passed through the CAPA process and root cause analysis. You must understand some quality events can be fixed with minor corrections. For this, you must understand the risk threshold of the quality issues. If the risk severity is higher, you must pass such nonconformances through the CAPA system on priority. You can develop a risk matrix or choose a CAPA management system with an in-built risk matrix. It will be much easier and more efficient to deal with quality issues afterward.

2. Lack of Training in CAPA-Related Tools

Another common concern is that people are unaware and trained on the CAPA-related tools such as root cause analysis, investigation, and much more. This is because people are used to the reactive approach. They correct the quality issues with immediate corrections and then forget about it unless they get repetitive complaints about the same.  You must first identify the tools that best suit your organization’s requirements. Then, train your employees to ensure best practices are in place. Finally, you can integrate training management software with your quality system to ensure that your staff is regularly trained on industry-proven best practices. This will further build a culture of quality and compliance within the organization. 

3. Not Identifying the Root Cause Effectively

We have just discussed how people perceive the idea of resolving quality issues. They look for a quick fix or correction to eliminate the problem. But the harm of the quality issues goes beyond that. They can have severe consequences regarding brand reputation, customer trust, and compliance. Just having a system in place may not help. The focus should be on the process. It would be best if you standardize the processes so that your employees get used to them over time. As they say, “Practice drives perfection.” So, document every best practice and have your employees follow it regularly. You may hear what works and what doesn’t for your employees. This kind of involvement is what it takes to achieve excellence in every aspect. 

4. Not Having the Right People Involved in CAPA Process

Suppose you have everything in place, including process, documents, systems, training, and best practices, but you are still stuck with repetitive issues. Doesn’t that sound overwhelming? It obviously does!  You must be wondering what’s wrong now. And the answer is People.  Yes, you read that right! You might not be involving the right people in your CAPA processes. So, you must create a cross-functional team with a person with process insights, a decision-maker, an auditor, a person who can lead and implement change (if required for mitigating risks), and so on, depending on your objectives.  

Having the right people is key to success in every CAPA process. 

5. Lack of Verification Methods

All the action plans implemented during a CAPA process must be effective enough to mitigate the issue and prevent its recurrence in the future. The best way to do that is to keep track of the same problem for a period and report similar occurrences. Then, if you do not re-encounter the same issue, it would be considered a successful CAPA implementation. But the regulatory bodies require objective evidence for the same.You must train your teams on verification methods and sequentially document every activity. The manual systems may take a longer time. It would be best to have a cloud-based CAPA Management system to document every detail of the CAPA, including their effectiveness review. The CAPA records stored in the software database can also be presented as evidence of best practices to the regulatory bodies. 

6. Lack of Traceability

Whenever a quality issue is reported, the focus is on resolving them. This makes the organization overlook the opportunities to improve or implement preventive actions to avoid similar problems in the future. It could be due to a lack of traceability. It is common for organizations that are working with disconnected systems. The organizations need an integrated solution wherein they can track all the data in one place, analyze it, and make intelligent decisions. That’s where cloud-based solutions can help. Such solutions offer greater flexibility, traceability, and security. The next-generation CAPA solutions are what the evolving businesses need to handle CAPAs more effectively and efficiently than ever. 

7. Improper Documentation

Regulations are stringent regarding documentation: if you cannot provide proof that corrective steps have been taken, it is impossible to prove them. The auditors also review documentation. Creating a form that verifies documented efforts to completion is the most efficient way to ensure documentation compliance.  Using forms, you must provide information about the investigation, the root cause analysis, the containment or correction, and the corrective action. CAPA forms are commonly used in many organizations, which incorporate a “mandatory” section that prevents the person filling out the form from moving on until all the necessary information has been entered. You can use Forms Management Software to create and manage records efficiently. Therefore, it is essential to ensure that documentation is complete and that someone verifies it. 

8. Not Having a Culture of Continous Improvements

Making improvements is all about changing how we manage quality for products, processes, systems, and documentation. And change is something people resist pretty often. It could be due to any number of reasons. So, you must identify those reasons and make people understand how change can bring better results for everyone, including customers, organizations, and even themselves. First, you need to make your employees aware of the purpose and scope of change that will be implemented. Then you can use a change management system to implement changes systematically. 

9. Absence of Standardized Complaints Management System 

Monitoring customer complaints and satisfaction data can also prove to be invaluable when it comes to justifying CAPAs. Despite this, many organizations have a standardized complaints management system in place. The complaints management system helps you efficiently track the quality issues identified by the customer and resolve them on time. This will further help maintain customer trust and loyalty. 

The Bottom Line 

In the early 1990s, the market was overwhelmed by an endless wave of quality systems. Since then, the need to implement them has only grown! 

It is not only a market demand to improve processes, reduce costs, and deliver the best product or service. It is vital to the existence of the company.  

In this post, we will discuss the importance of quality management systems in the success of a business. Moreover, we have assembled a list of the Top 10 Quality Management Software available in the market. So, you can choose the suitable QMS for your organizational needs and utilize it to transform the quality management game. 

What is a QMS? 

An enterprise-wide Quality Management System (QMS) consists of an established set of policies, procedures, and practices. This system directs and controls critical business activities. In addition to continual improvement in effectiveness and efficiency, the QMS aims to provide optimal performance at all times. 

A quality management system helps businesses to lower costs, improve performance, reduce waste, and provide a training baseline for new and existing employees. 

What Can Quality Management Systems Do? 

QMS improves your business’ operations and enables it to meet customer demands. ISO 9000 defines quality management as documentation of all business processes followed closely by people. This is the basis for many types of quality management systems. In either case, you can ensure compliance with the latest standards and regulations without outsourcing all your processes. An ISO certification enables your company to improve efficiency and reduce waste by implementing Total Quality Management (TQM). All aspects of your business can benefit from TQM, from the front desk to the production line. 

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

Nowadays, you can easily find powerful quality management software to assist you with total quality management. Some of the top-rated QMS are: 

1. Qualityze 
2. Qualio 
3. MasterControl 
4. ComplianceQuest 
5. ETQ 
6. Sparta Systems 
7. SmartSolve 
8. Intellect QMS 
9. IQS 
10. isoTracker 

1. Qualityze

Qualityze offers a suite of next-generation Quality Management Software Solutions to help businesses manage end-to-end quality from anywhere. It is built on the most powerful and secure cloud platform, i.e., Salesforce.com. It provides required flexibility, scalability, and security to manage business critical data and processes efficiently. It comes with amazing in-built capabilities to reduce overall process cycle time. The solution provider also offers data migration and validation services. In addition, the solutions are specifically designed to meet FDA, ISO, and GxP regulations. 

Qualio is a cloud-based quality management solution that comes with robust tools and features to simplify the development, production, and distribution of quality products. It is specifically designed to meet the regulatory requirements with a flexible pricing model. It can accommodate growing needs of the business. Some of the cons with this solution is that it does not supports multi-user ownership for drafting the documents and its complex database schema that makes is challenging for users to import. 

What to Expect: 

1. Added security, powerful administration, and metrics with cloud-based platform. 
2. Integration challenges with third-party systems like ERP and CRM. 
3. Useful for companies working towards ISO certification. 
4. A versatile software with a higher cost. 
5. A little complex interface that may requires users to undergo training for smother user-adoption and limited document size. 

3. MasterControl

MasterControl’s software platform enables companies to improve quality management, such as employee training management, change control and audits, and more. It keeps quality in check from conception to delivery. MasterControl’s extensive portfolio spans the entire product development lifecycle and is a perfect enterprise solution for global organizations. In addition, you may be suitable for implementing and customizing it if you need a complex, highly configurable QMS. 

What to Expect: 

1. Good connectivity among different modules and processes. 
2. An issue with search speed since it supports exact match search. 
3. A challenging user interface with robust features. 
4. Some compatibility issues may arise, depending on the browser you use 
5. Better collaboration and administration. 

4. ComplianceQuest 

ComplianceQuest is a powerful EQMS solution, enabling life sciences and manufacturing firms to streamline product and process innovation, reduce risk, and drive continuous improvement. Our EQMS offers a wide range of solutions, including document, inspection, nonconformance, change management, and many more. Because of this, it is suitable for a wide variety of industries, from highly regulated ones like Life Sciences and Food and Beverage to general and specialized ones such as Automotive, A&D, Oil & Gas, Hi-Tech, and CPG. 

What to Expect: 

1. Advanced reporting capabilities. 
2. Automated and efficient workflows. 
3. Higher costs. 
4. You cannot conduct impact assessment for document or DCR changes. 
5. A delay in deployment because the out of the box setup did not meet FDA and ISO regulatory requirements. 

5. ETQ 

ETQ, a leader in quality, compliance, and health & safety software, is trusted by global brands across industries such as manufacturing and life sciences, food and beverage, and electronics. It features a wide range of features such as document control, supplier quality, audit management, risk management, advanced analytics, and non-compliance/corrective actions to drive business excellence. The software is suitable for quality-focused companies of all sizes and across dozens of industries, including manufacturing, life sciences, food and beverage, electronics, automotive, chemicals, and consumer goods. 

What to Expect: 

1. Great customer service and technical support. 
2. Flexible design for managing workflows. 
3. Some features are complex, and it often crashes. 
4. The interface is not so interactive. 
5. Unclear error messages that may confuse the non-IT users. 

6. Sparta Systems

The TrackWise eQMS product from Sparta Systems is designed for companies with strict GMP requirements. Vendors position their product as a comprehensive QMS solution that allows organizations to become more visible and efficient than ever. Enterprise organizations can use this solution to integrate with a complex ecosystem of systems including ERP, CRM, LIMS, and MES applications. 

What to Expect: 

1. Systematic way to track approval workflows. 
2. Possibility to generate KPIs. 
3. Improved efficiency when it comes to managing tasks. 
4. A little delay in customer service due to limited query manager (Reported by a user on Capterra). 
5. It is expensive and very extensive to train developers and administrators. 

7. SmartSolve

Pilgrim, an IQVIA company, offers SmartSolve, an EQMS software solution that manages compliance, risk, quality, and supply chain processes in the life sciences sector. It provides workflows, documents, and process management and is built under the ISO 9001 standard. Software is rated as pretty good. However, some people have experienced some inherent programming bugs while some reported that their implementation teams often create new bugs when fixing old bugs, in lieu of rushing things. 

What to Expect: 

1. A cumbersome interface with lots of different functionalities 
2. Administrative controls and advanced project management features. 
3. A comprehensive solution for managing risks and quality. 
4. A reliable EQMS to meet compliance requirements. 
5. Some inherent bugs and lengthy implementation cycle. 

8. Intellect QMS

Intellect QMS is designed to improve quality operations and reduce overall quality costs. With our no-code compliance platform, Intellect QMS’s easy-to-use, fast-to-implement, highly flexible, and best-in-class customer support is all available out-of-the-box. You can integrate it with additional business applications. Also, you can meet compliance, enhance audit metrics, improve throughput, reduce the turnaround time, lower quality costs, and reduce returns, defects, and more. Most Intellect’s customers are midmarket companies. It works with startups to Fortune 100 companies. 

What to Expect: 

1. Good in terms of configurability and customer service. 
2. Inconsistencies with the documentation package, execution, and documentation effort. 
3. Some of the FRS, URS, and Guides are not even accurate. (Reported by Capterra user) 
4. Smooth implementation. 
5. Heavy user configuration to configure OOB workflows and configurations to reflect typical QMS workflows for the pharma/med device industry. 

9. IQS 

IQS CAQ helps businesses meet quality requirements. A module is available for each task, as well as standalone usage. For example, a manufacturing company may use these deployments for shipping or receiving goods, planning tests, acquiring data, and planning feasibility. Companies with many suppliers will benefit from advanced quality planning, supplier evaluations, and supply chain quality center modules. High-quality manufacturers will benefit from this module. The several modules of software deal with quality assurance. 

What to Expect: 

1. Higher control of supply chain operations. 
2. Standalone modules for different tasks. 
3. Compatibility issues may arise due to lack of deployment and support options. 
4. Lower inspection costs. 
5. No user reviews on Capterra Yet. 

10. isoTracker

ISO Tracker is a cloud-based Quality Management System designed specifically for small to medium-sized businesses. It has modules for document control, complaints management, auditing, non-conformance management, risk management, and training. In addition, the software includes a capability for Corrective and Preventive action (CAPA). It enables you to demonstrate compliance with ISO 9001, ISO 14001, ISO 45001, ISO 22000, and other quality management standards. A wide range of industries can use it, including healthcare, manufacturing, logistics, engineering, food and beverage, medical products, manufacturing, electronics, chemical, packaging, technology, consulting, and biotechnology. 

What to Expect: 

1. Very good customer support. 
2. Robust user controls for accessibility.
3. Setting it up is quite intensive and confusing because of the category bundles in the solution (as per the Capterra Review). 
4. Lack of root cause investigations in the internal CAPAs. 
5. Incapability to copy folders. 

Every organization should have a quality assurance program. Logistics companies should ensure quality assurance when implementing next-generation technologies to protect their sophisticated processes. Also, they must be able to see the entire operations process, from A to Z, to be more efficient and profitable. For this purpose, they need robust and compliant quality management software.

Logistics have become an increasingly critical point of contact between sellers and buyers as e-commerce and virtual marketplaces gain popularity. Beyond its increasing significance in the B2C segment, logistics’ traditional role in B2B value chains is growing at unprecedented rates.

Logistics operators are an integral part of any supply chain. Transferring raw materials from various sources to manufacturing facilities and finished goods to multiple warehouses includes transportation. It then plays a role in moving the goods to different channel partners, outlets, and end customers.

The product must be delivered on time to the right place without damage, all of which need well-designed coordination. That is where quality assurance is crucial to ensuring that best practices are followed when moving a product from one place to another.

But that does not mean that you do not need a quality management system in your organization. You must understand quality assurance is just a part of the quality management spectrum that includes many other things such as quality control, risk assessment, and more. It becomes important to understand the operations of the logistics industry to develop quality assurance programs and strategies.

Managing Logistics Involves Complex Operations.

There are many points of origin and destinations associated with logistics operations. Some of these activities include:

• planning logistics networks,
• transport management,
• vehicle management,
• inventory management, materials handling, order fulfillment,
• packaging and assembly,
• Managing suppliers and third parties’ vendors.

Logistics processes are often more complex when handled by a third-party vendor.

Quality assurance and management are crucial to all these activities running smoothly. Logistics providers enhance a manufacturer’s reputation for quality, on-time deliveries, and within budget based on their dependability.

Quality Assurance: A look from the ISO perspective.

As per ISO, Quality Assurance can be defined as: “A coordinated set of actions assures that a product, process, or service will fulfill the quality requirements.”

Businesses that implement a quality management system for quality assurance demonstrate their ability to conform to specified quality management system requirements. The function of quality assurance is to support quality improvement, identify and address the risks and opportunities associated with an organization’s context and objectives, and guarantee that customers’ requirements are met while complying with regulatory and legal regulations.

Related Article: Why is Quality Assurance Important in the Logistics Sector?

There are several aspects of quality assurance, such as:

• External audits by an independent company
• Document control and management (GxP documents, SOPs, specs, and work instructions) so Logistics Value Chain personnel can access the required information promptly.
• The logistics value chain should employ adequate training for all employees to discharge their tasks, follow processes, and adhere to SOPs.
• Take corrective action when quality events occur.
• Analyze trends, determine root causes, and prevent them from occurring again.
• Reducing delivery delays and lowering costs.

Improving Logistics Management Quality through Automation

As a result of strategically integrating quality assurance, quality control, and quality management, logistics quality management system provides the following advantages:

• Increased efficiency.
• Higher productivity.
• Better customer service.
• Cost savings.
• Timely deliveries.

Manual systems inevitably fail due to the complexity and multiple points of contact associated with logistics operations. It results in confusion and delays. By automating quality management in logistics, tracking and monitoring can become smoother and more efficient, minimizing events.

Logistics operators can manage quality control and quality assurance with Qualityze EQMS Suite, a cloud-based Enterprise Quality Management System. It helps you meet compliance requirements. As an integrated system, it assists organizations in gathering, sharing, and managing safety and quality information and is compliant with the following regulations:

• ISO 9001:2015
• ISO 14001
• ISO 18001/45001
• ISO 13485
• FDA

Among the next-generation capabilities of Qualityze EQMS for logistics is:

Analysis and Reporting: Streamline performance tracking and reporting by capturing metadata. Clients, regulatory agencies, and the board can generate reports with full transparency using the intuitive dashboards in the solution. It allows you to lower insurance costs and enhance your safety program.

Integrate and Eliminate Redundancy: Ensure your quality and safety programs continuously improve by collecting data from all sources and reporting the results.

Assuring Quality Throughout the Lifecycle: Managing the audit lifecycle by providing checklists and online or offline resources to your auditors, so they can complete their work and produce the audit report at the click of a button. It also simplifies the management of external and third-party audits.

The Reporting of Quality Events and Deviations: Improving safety culture and awareness through proactive and reactive reporting of quality events. Ensure the employees have the authority to collect, review, and report information relating to adverse events, failed controls, barriers, and near misses. Encourage employees to share experiences. Auto-report adverse events to regulatory agencies.

Corrective/Preventative Actions: It provides an efficient means to take immediate corrective action in an incident and prevent further occurrences.

Root Cause Analysis: It allows your teams to identify the root cause and take appropriate action to resolve them. The system allows you to assign and manage investigators, standardize their workflow, and keep track of their progress, activities, and results.

Digital Signature Validation: Qualityze EQMS Suite helps users to control and validate the data using in-built digital signature capability. It ensures that only authorized users have access to the business-critical data. Moreover, it becomes easy to track the details of a record/activity. For example – who has performed the audit, when, and what are the tools used.

Quick Notifications and Alerts: The software allows users to schedule their tasks well in advance, so get the task notification before they are due. It helps save penalties and fines too especially when it comes to permit renewals, declaration reports, compliance forms, and much more.

The Bottom Line:

Logistics play a significant role in facilitating any supply chain, regardless of the industry. The quality monitoring market is also experiencing massive changes as increasingly disruptive solutions emerge, notably software as a service. Keeping up with this can be frustrating, but it is ultimately good for the industry. Innovative solutions make it easier to establish continuous communication channels and end-to-end visibility across all supply chain aspects.

The introduction of innovative technologies can be challenging. Logistic companies should ensure that the implementation process goes smoothly and that the technology they adopt is effective. In this situation, there is an absolute need for quality assurance to make sure the supply chain does not fall into madness and is functioning as optimally as possible. But Qualityze EQMS Suite simplifies it all. Learn more about it here: Qualityze

You can learn more about the Qualityze EQMS Suite and how it can help you improve productivity, quality, and safety in your logistics processes by contacting our customer success team on +1-877-207-8616 or write to us at info@qualityze.com. We will get back to you at the earliest.

In today’s market, companies that wish to remain competitive and earn consumers’ trust must ensure quality. The nutraceutical industry is no exception, where product safety is crucial to brand success.

Nutraceuticals are subject to different regulations in different countries. Food and Drug Administration (FDA) regulates the processing, manufacture, and sale of dietary supplements in the United States. Companies are prohibited from using misleading marketing and branding schemes. Furthermore, they must adhere to FDA good manufacturing practices (GMP) and test their products for safety.

Related Articles: A Brief Guide to Federal GMPs for Dietary Supplements

An FDA inspection can result from any manufacturing or labeling violations. Even the most minor mistakes can have potentially deadly consequences that can lead to product recalls and millions in lost revenue and a company’s reputation.

To ensure proper controls and an effective quality system, the three main challenges must be addressed to ensure consistent product safety and compliance.

Nutraceutical Companies: 3 Top Challenges

Supply Chain Management.

Taking care of Supplier Quality Management is one of the biggest challenges for nutraceutical companies. Due to the continuous expansion of the global supply chain, businesses source their ingredients and inputs from various vendors and suppliers. To follow good manufacturing practices, a system must be implemented to collaborate with all suppliers. It is also necessary for companies to ensure that ingredients are sourced ethically and in compliance and keep track of non-conformances.

Accessibility.

Despite recent advances in technology, paper-based and other disconnected document and quality management systems lack the transparency required for modern business. Trending and reporting are difficult in real-time when data is kept in Excel spreadsheets and disconnected systems. Since safety in the nutraceutical industry is a top priority, monitoring quality, production, and testing data in real-time allows companies to solve problems before they occur.

Integrated processes.

It is not acceptable to complete quality processes in parts. One issue can impact another, so holistically, product and process problems should be considered. It is essential, for instance, to link customer complaints to risk management activities to conduct a re-assessment and to CAPA to complete any necessary actions. Process integration reduces compliance gaps and ensures an effective and efficient quality management system.

Regulatory aspects of nutraceuticals.

Regulatory issues surrounding nutraceuticals present a considerable challenge to the internationalization of these products, with different definitions and definitions of these products in other countries.

Nutraceutical regulation has been mainly concerned with safety and labeling instead of pharmaceutical law. Thankfully, Good Manufacturing Practice (GMP) regulations and increased enforcement have made this possible.

Consumers primarily determine the value and usefulness of nutraceuticals. However, increased regulation concerning the safety and quality of these products would benefit the industry and mitigate any adverse effects.

Regulations for nutraceuticals

Nutraceuticals are subject to a wide range of regulations around the world. Unfortunately, the regulating industry often falls into a grey area of uncertain information and expectations that are sometimes misleading, dangerous, and confusing. To make informed and safe decisions, both manufacturers and consumers should know their nation’s nutraceutical regulations.

European Regulations (EFSA)

Nutritional supplements are defined and regulated by the European Food Safety Authority (EFSA) as products that provide nourishing and physiological benefits and regular dietary intake. In addition to vitamin, mineral, and amino acid content, the strength and amount of the ingredients are essential. Any company wishing to include vitamins, minerals, or other substances not included on this list should apply to the E.C. for consideration. Likewise, vitamins, minerals, and other substances not included in the directive can be added by using the E.C.

Through the Regulation (E.C.) No 1924/2006, the European Commission has established Union rules regarding Nutrition and Health Claims. It became effective on 1 July 2007.

This regulation provides food companies with the legal framework they need when they wish to highlight the specific health and nutrition benefits of a product, either on the label or in its advertising. A nutritional claim and a health claim are subject to these rules.

According to these rules, any claims made about food on its labeling, presentation, or advertisement within the European Union must be accurate, precise, and supported by scientific evidence.

The E.U. prohibits the sale of food that includes claims that could mislead consumers.

It protects consumers, promotes innovation, and ensures free and fair competition. Furthermore, by allowing companies to submit the same claims on their products anywhere within the European Union, the rules provide free circulation of food-bearing claims.

USA Regulations (DSHEA and FDA)

Dietary supplements are regulated differently from standard food and drug products by the U.S. Food and Drug Administration (FDA). It is why DSHEA was passed in 1994 with significant public involvement, both in support and opposition. In the United States, the DSHEA defined and regulated dietary supplements. Manufacturers are prohibited from making unproven claims and must comply with specific FDA regulations.

The DSHEA describes nutraceuticals as “an ingredient intended to supplement the diet, such as vitamins; minerals; an herbal component; an amino acid; an ingredient designed for human consumption as dietary supplements; or a combination or concentration of these ingredients.”

The manufacturer’s responsibility and quality control

In the absence of benchmarks for nutraceutical regulation, supplement manufacturers must maintain a high level of quality controls to keep consumers safe, not to mention pay hefty fees and penalties. Even though country-specific regulations can differ, manufacturers must always maintain quality control and traceability. A thorough test can mitigate many risks at every step, including, but not limited to:

1. Ingredient inspection to detect contamination from environmental factors to avoid product recalls and wastage.
2. Process level approach to keep a check on formula measurements. Even a minor change in measures can lead to catastrophic consequences.
3. Good manufacturing processes to be followed by everyone, ensuring a culture of quality.
4. Testing the final products if they conform to the standard requirements.

If you have questions about Qualityze EQMS Suite, you can contact our customer success team. You may reach us at 1-877-207-8616 or email us at info@qualityze.com, and we will be able to assist you.

A lot of food products are susceptible. It is why the food industry must adhere to quality requirements and maintain quality standards. Food is one item we repeatedly buy from the same brand, believing that it meets our expectations and is of excellent quality. Even a tiny blemish on quality could damage a brand’s reputation in this industry. In this case, profits might go down the drain for the company. Therefore, quality control measures are of the utmost importance for food brands. Quality control (QC) identifies and corrects defects in finished products and is a reactive process. To achieve constant customer satisfaction, the sources of quality problems must be identified and eliminated. It is an aspect of quality management that involves inspecting products for defects, and it is typically done by a team that has been designated for that purpose. 

Quality Control and Quality Assurance: What is the Difference? 

When it comes to making sure products are of a high standard, quality control, and quality assurance are frequently used in the same way, but how do they differ? 

Despite their close ties and inclusion in quality management, quality control and assurance have fundamentally different goals. Quality assurance is intended to prevent defects, while quality control is intended to identify defects.  

To learn more, let us take a closer look at both terms. 

What does Quality Assurance mean for the Food and Beverages Industry? 

Quality assurance (QA) is a set of activities designed to ensure that products developed through the development processes are high quality. As a proactive process, it targets the process by which a product is made to prevent defects from occurring. QA aims to eliminate defects during development by improving development and testing processes. 

Quality assurance requires establishing an effective quality management system and assessing its effectiveness. Additionally, all development team members are responsible for ensuring quality is achieved.

Quality Control: Why it is So Important? 

Below are some reasons why companies dealing in foods and beverages should not ignore quality control: 

Lower production costs  

Companies can significantly reduce their production costs by conducting effective inspections and controls during production and operations in the food industry. Substandard products and waste increase production costs even more. Keeping track of the quality of products and wastages makes production more efficient and lowers the cost of manufacturing. 

Related Article: Digital Records helping Manufacturing Companies to reduce the Quality Costs to Halves

Positive Customer Experience 

Quality control enhances the goodwill of a company by manufacturing goods that are of higher quality and meet the needs of customers. Consequently, offline, and online advertising channels result in a positive brand reputation. Businesses with a positive reputation can raise funds quickly. Moreover, a company with a good reputation is more likely to survive in a highly competitive market if its goodwill is enhanced. 

Streamlines Pricing 

It is possible to ensure uniform product quality by implementing quality control measures in the food industry. It dramatically simplifies price-fixing. Companies no longer must worry about commodity prices changing continually. 

Maximize Revenue 

By maintaining quality control, a company can produce superior quality products, attract new customers to the brand, and increase sales. In addition to providing maintenance of current demand, it generates a new market for the company’s products. With the rise of social media, it has become more critical for brands to watch what is happening. Negative customer feedback can undermine a brand’s reputation. 

New Production Techniques 

Quality control systems guarantee that commodities are produced at the desired standard and a reasonable rate. In addition, quality control aims to ensure that production methods and designs are improved by obtaining technical and engineering data about the product and its manufacturing process. 

Increased Employee Engagement 

Having a quality control system that works effectively increases employee engagement. Employees tend to be more motivated and willing to work toward the company’s goals when they feel like they are working in a company that produces good products of higher quality. These employees are also more likely to comply with the company’s quality control standards while performing their tasks. 

Quality Control: What is the Most Appropriate Way to Manage It? 

You might put a lot of effort and time into growing your company but recalls of food, poor products, and negative customer experiences and health impacts will drastically reverse any progress. So, it makes sense that quality control should be of high priority within your company. 

Qualityze offers a set of integrated modules that helps streamline all the critical processes contributing to quality of food products. It is delivered on a compliance-ready platform, i.e., Salesforce.com. It comes with impressive in-built capabilities. 

If you want to explore product functionalities or have any other queries regarding Qualityze EQMS Suite, please feel free to contact our customer success team on +1-877-207-8616 or write to us at info@qualityze.com. We will get back to you at earliest. You can also get your free demo scheduled to see a virtual tour of product interface and functionalities. 

Every year, information-intensive businesses spend billions of dollars just to migrate the data. Yet, most of the new systems do not live up to expectations, typically because migration errors lead to partially validated data.

Due to the view that the system itself is an investment, any data migration effort is often perceived as an unavoidable and expensive affair. This results in an overly simplistic, underfunded approach. However, migrating to a new system as part of investment offers the business better access to accurate data that supports its needs and helps to reduce the risk of delays, scope reductions, and budget overruns. 

The global Cloud Data Migration market is predicted to grow at a CAGR of nearly 30% from 2021 to 2030. Therefore, every business must value information as an asset and employ data analytics to gain a competitive edge. 

Why is Data Migration Important? 

It is usually necessary to migrate data when switching to a new system.

For example, relocating or consolidating an application may be required to replace a legacy application or deploy a new application alongside another application.

The goal of data migration is to improve performance and gain a competitive advantage, regardless of its specific domain. Having accurate data can maximize the value of an enterprise application.

However, migrating existing data to a new application can introduce inaccuracies, redundant and duplicate information. The data in the source system may be inadequate to meet the requirements of the target system, both in terms of content and structure. Safety is another concern when it comes to data transfer. Unsafe data transfers will amplify errors or irrelevant information, perpetuate hidden problems, and put you at risk.

Critical Challenges of Data Migration 

• Availability of data in an unorganized state

Data may have multiple versions when it is first created from scratch. Messes typically arise from duplicates of a document or a file or incomplete data sets of a document or a file.  

Before moving to a new platform, you should clean this data so that it won’t be messy or disorganized right from the start. With a knowledge management system powered by Artificial Intelligence, data in this scenario can be deduped after migration to reduce costs. 

• Inadequate data protection

A common concern during data migration is data loss. Data loss is inevitable during data transfer, primarily at the organization level. It is difficult to rely on new content right away because of data loss. Losing data can be highly disturbing However, data loss can be negligible when it comes to junk files or duplicates of files, which are no longer needed.

However, organizational data may contain confidential or private information despite being inconvenient to daily operations. Therefore, to ensure that there is no data loss, you should have a backup of all files, irrespective of whether they are essential or not. 

• Incorrectly formatted data 

The organization’s data and the compatibility of files are to be checked during data migration. It is essential to format documents before just transferring them, as they must be opened in a format that works with the new software on the server or the device.  

A file may not be compatible or have access controls if it has not been formatted before it is transferred. By inspecting the device’s current settings and the operating system used in the extension, you can ensure files are appropriately formatted. Before moving, you must decide which changes the files need to make to work on the new server or software.

• Analyzing and mapping data 

When new data is transferred from the old database, mapping refers to determining where the new data goes. The main objective is to decide where to store the data in the new database.  

Turning a manual knowledge management system to one that is more efficient, a critical step is for the workflow to adjust due to the ease-of-use features within the knowledge base software. It might be complex, but your knowledge management partners need to specify how you might simplify the process.

• Bringing data into the system 

Data has been cleaned, formatted, and mapped; now, the information must be imported to the new platform. As a result, you have better search capabilities, a more cohesive interface, and better data organization when you move to a new knowledge base platform.  

This is only possible when you import data correctly. It may be necessary to move all information tables at once to improve search results. Currently, organizations should spend more money to ensure the successful use of the new knowledge base features in the long run. These measures will allow them to expand their business.

• Lack of collaboration among teams

Data migrations do not require the same technology, different people, and in some cases, a mix of internal employees and contractors. Some of these employees might even be in other locations. Working in silos and creating more data silos can lead to inconsistencies and decrease productivity.

It is more common for people to avoid responsibility when things go wrong rather than taking action to resolve the issues. Collaboration tools help with migrations by enabling all participants to view data in the same way as it moves through the stages, thus preventing mistakes and misunderstandings.

• There is no integration of processes 

There are typically multiple people and technologies involved in data migration. Data and its design will not be transferred smoothly between the analysis, development, testing, and implementation stages if disparate technologies are used. Information may be lost during the transition. To reduce error rates and save time and money, organizations should consider implementing a platform that combines each stage’s critical inputs and outputs.

• Finding the Right Experts 

Data migration activity is crucial since businesses drive maximum value from the data collected over the years. If you do not have the right experts to do the migration job for you, you will likely put your data at risk. Make sure you get the right people on board to perform the data migration safely.

In data migration, you face challenges and high risks. Still, if you identify these hurdles early and overcome them before any data is transferred or transformed, you will have a successful migration.  

It can be overwhelming and confusing to search online for keywords like “training management” or “training management system.” The basic idea of training management may remain the same. However, not all training management systems (TMS) are the same.

Those without any experience in training management solutions may not be able to spot the difference between different training management solutions. But if you end up purchasing one, believing it to be the other, the mix-up could be unforgiving for your business. So, what exactly is a training management system? And how can you choose the best one for your organization?

It is challenging to choose the right training management software. However, you can opt for a solution that can make a difference by:

1. Reducing administrative tasks through automation

The ideal world would be for your employees to spend more time training than on administrative tasks. Automating several training tasks with training software saves your employee’s valuable time. It can track training certificate expiration dates, digitize documents, and reduce paperwork. Employees who use automation can concentrate on learning because they are not distracted by monotonous tasks. For example – you do not have to print out forms and complete them manually, nor do you have to hunt through a mountain of files to find the right document. The software can automatically assign courses to employees based on their roles and previous training.

2. Streamlining mass uploads

It takes an extended amount of time to upload and enter data manually. If large companies do not use software that can mass upload, they may need to hire full-time administrative staff. In addition, the number of training records generated by a significant corporation increases along with its headcount, creating thousands of new training records in a fleeting period. An Excel spreadsheet or an existing database should be able to pull substantial amounts of data into training management software. Otherwise, updating information and employee profiles will require many hours of data entry. Employees can perform this task more efficiently and without human error with software that can complete it in seconds.

3. Making a free trial available

You should test the main functions of a training management software before purchasing it and see if it meets your needs. Software providers who offer a free trial are confident about their products. Some software options may seem like good deals, but hidden charges may be. For example, it may have a low price for its basic version, but you must pay more for its robust features.

4. Providing greater accessibility and traceability

Accessibility and traceability have become even more critical in recent years. The software that does not allows access to or track your training activities is not likely to gain the user’s attention. Today, training managers look for a training management solution that gives them and employees complete accessibility to training documents while enabling them to track their progress. You can achieve the required level of accessibility and traceability only by using robust training management software like Qualityze.

5. Delivering detailed reports.

The amount of data managed by Training Software is unchanged, despite eliminating physical documents. A quality piece of software will be able to generate detailed reports with this information, which can help decide future courses and other management decisions. Additionally, companies can use automatic reports for gap analysis, identifying their weaknesses and skills they need to improve. You can use a detailed report for compliance as it provides all the information an inspector needs instantly – no need to gather information and prepare reports manually.

Key Benefits of Using a Cloud-Based Training Management System/Software?

A cloud-based training management software can drive multiple benefits for an organization, including:

Centralized database for keeping all the training materials in one place without any confusion. The software stores training documents in a systematic order so you and your teams access the most recent version. It further ensures that everyone is on same page when it comes to maintaining a culture of quality.

Digital signature validation to ensure that only authorized people are accessing to the training documents. It also helps training managers to track people who completed the training in the specified time.

These are just a few to mention. You can leverage many other benefits with a cloud-based training management software. Make sure you choose the best one having the features discussed above. It can be little time-consuming to search through a variety of options available online. But we can make it simple for you with a quick yet worthy recommendation i.e., Qualityze Training Management Software.

With Qualityze training management, you can manage, execute, and maintain your organization’s training program in the cloud. With this feature, you can organize all the training essentials your company’s training team needs, including certifications, qualifications, and training records. This keeps you in compliance with internal and external requirements. Depending on the job function, department, business unit, process, location, site, and individual, you can create different training requirements.

Related Articles: 7 Signs You Should Seriously Take an ‘EQMS Way’ of Managing Your Training Requirements

Would you like to experience Qualityze difference in managing your teams’ training requirements globally without any hassles?

You can get in touch with us today.

For more information on our products and how they can assist you in staying ahead of customer and product issues, please feel free to connect with our customer success team on +1-877-207-8616 or email us at info@qualityze.com. We will contact you as soon as possible. Feel free to request a demo right now.

Defense, aerospace, and aviation are among the world’s most regulated industries. The qualification requirements for suppliers in these sectors include the compliance requirements of quality management systems, such as AS9100, AS9110, or AS9120. From design and manufacturing to operations and maintenance, all aerospace organizations will find the standard helpful for their regulatory, safety, and reliability requirements.

Certified suppliers are eligible to pursue potential business opportunities both domestically and abroad. Furthermore, every company that has been certified by AS9100 is listed in the Online Aerospace Supplier Information System (OASIS) maintained by the IAQG. The database provides information about suppliers and purchasing contacts for companies in the aerospace industry. Consider OASIS as a free aerospace marketing tool.

AS9100 Certification: What is it?

A QMS is certified with AS9100 when it has been independently reviewed against the AS9100 standard requirements by a third-party certification body. If you are certified, your customers know that they don’t need to audit your QMS independently since an independent party has already audited it against the AS9100 requirements and has certified compliance with it. When you complete the AS9100 certification audit, the certification body will issue a certificate, which you can use as objective evidence to meet the standard.

What is the significance of AS9100?

There are specific requirements for the aerospace industry, and the QMS must include these requirements. As an aerospace supplier, you need to demonstrate your commitment to quality, not only to be sure that you meet these aerospace-specific requirements but also to improve your business’s efficiency and enhance customer satisfaction. Using an AS9100-compliant QMS can help you do that. In addition, your customers will feel comfortable knowing that everything is handled correctly if you manage, control, and audit your processes and have an external certification body verify that your QMS meets the requirements.

AS9100 was written as an international standard for aerospace quality management systems based on seven quality management principles considered essential to make a QMS work. You base your QMS on these principles to make your customers happy. Certification by AS9100 is itself one of the enormous benefits, as certified companies must be a part of the Online Aerospace Supplier Information System (OASIS) maintained by the IAQG. In this database, which is searchable, you can find information about companies, their products, and contact information for purchasing. You can use this to select your supplier or to monitor your supplier. The aerospace industry uses OASIS to find suppliers, so it is a free marketing tool for your company.

What are the steps to become AS9100 certified?

You must implement AS9100 requirements before you can undergo certification audits. Therefore, using a QMS is crucial because it will allow you to perform the following tasks before certification:

Internal audits: Your internal audit process allows you to determine whether your processes are following the planned arrangements and, if not, to identify the root cause of any problems. It can expose and address weaknesses within your QMS.

Management reviews: To ensure a QMS is being implemented effectively and efficiently, management must review the system in its commitment. It then assigns resources accordingly.

Corrective action: If your QMS encounters a problem during use, you need to find the root cause of the issue and take action to prevent it from happening again.

What are the Stages of the AS9100 Certification Process?

There are two stages to the certification process:

Documentation Audit (Stage one) – The auditors will review your QMS documentation and determine whether it complies with AS9100.

Related Article: Importance of Documentation in Quality Management

Certification Audit (Stage two) – This step involves auditing employee files and interviews with this company’s employees to ensure your QMS processes give results that match each process’s plans.

Both the stages can be easily managed by using a integrated quality management system.

What is the average time to get AS9100 certified?

For calculating AS9100 certification costs, you must consider how long it will take to implement the system before you can undergo the audit. AS9100 certification takes different amounts of time for various companies. For example, it may take longer to implement a QMS if it includes design and development aspects.

In addition, a complicated configuration management system, the implementation of counterfeit part management systems, and product safety regulations contribute to the lengthening of the implementation time in an aerospace company. Using a gap analysis tool that compares your existing systems and processes with the requirements of AS9100 can help you determine what it might take to implement AS9100 within your organization.

How does AS9100 benefit organizations?

Being AS9100 certified could mean multiple benefits for organizations because it:

• Helps align business key processes to the industry-proven best practices.
• Demonstrates your organization’s commitment to delivering quality products and services consistently.
• Ensures that your quality management system is up to global aerospace standards.
• Enhances your prospects for new markets / new customers around the world.
• Provides robust design processes for organizations responsible for the design to meet safety and reliability demands in the Aerospace industry.
• Streamlines supply chain controls, which are essential to successful purchasing.
• From planning, purchasing, and manufacturing through shipment, each step of product realization is controlled to deliver a product that meets customers’ requirements.
• Defining requirements for product validation before shipment as part of the product monitoring and measurement process.
• Reduces the number of 2nd and 3rd party audits.
• Promotes continuous improvement by providing independent feedback.
• Increases customer satisfaction.
• Reduces inefficiency and waste within an organization.
• Improves business processes and operational excellence.
• Stabilizes processes and improves their consistency.

Define AS9100 Quality Management System?

AS9100 is described as a “Quality Management System.” An organization’s Quality Management System consists of policies, processes, documented procedures, and records that define how products, services, and methods are carried out. Quality assurance is only one aspect of QMS. AS9100 provides guidelines for creating an Aerospace QMS that ensures that you don’t miss any essential elements because you need to customize the QMS to fit your company’s needs.

Which is the Most Reliable Quality Management System?