How to ACHIEVE Operational Excellence with CAPA

Posted by Peter Hargittay on Tue, Dec 04, 2018 @ 10:50 AM

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Corrective Actions and Preventive Actions (CAPA) is a critical quality application that is instrumental for achieving operational excellence. CAPA improves product quality and safety, increases customer success, and yet decreases the risks such as product recalls.  With the right CAPA program, you can improve quality and business processes, uncover and solve process and quality problems, and develop new preventative actions to avoid issues in the future.

But how do you achieve operational excellence with CAPA? 

Build CAPA to Fit Your Exact Business Needs

Every business has unique processes and business requirements, and these needs often change as organization develop new products, respond to competitors, and adhere to new standards and regulatory requirements.  An efficient and effective CAPA program will leverage a robust pre-built application built on best practices and be easy to modify.

When CAPA is aligned with quality, compliance and strategic objectives, an organization can achieve harmony across the enterprise, and establish a foundation for operational excellence. The latest trend is quality management is smart quality automation, which goes way beyond traditional QMS software solutions that offer customization and configurability.

The Benefits of CAPA with Smart Quality Automation

Smart quality automation is the next wave in quality management software.  It’s designed to provide smarter quality, hyper-adaptive flexibility, actionable analytics enabling faster decisions, and better products.  Some of the benefits of CAPA with smart quality automation includes:

  • Reduce product recalls
  • Allow for design and engineering changes
  • Lower scrap
  • Reduce accidents
  • Reduce reworks and repair costs
  • Reduce returns and restocking costs
  • Minimize warranty expenses

 

In addition to reducing failure costs from products or services not conforming to requirements and customer needs, smart quality automation will boost your productivity, business agility, and decision making with real-time analytics.

How to Achieve Operational Excellence

Define your company’s quality goals and objectives, and then translate your quality goals into quality requirements.  Automate your quality processes, uncover inefficiencies, and establish new product processes.  Conduct employee training, create transparency, and standardization built around your company’s needs.  Finally, create custom reports for different departments, including an executive dashboard for management.  Operational excellence ensures that you’ll meet compliance, deliver high quality products, and deliver better results for your organization.

The Intellect eQMS Suite is a leader in smart quality automation with a highly agile platform to automate your business processes to match your operational needs today and tomorrow.  Intellect provides a robust pre-built CAPA application that can help you achieve your CAPA goals and objectives faster and easier than ever before.

Learn more about how the power of smart quality automation can help your organization achieve operational excellence.

Tags: operational excellence, CAPA, auditmanagement, employee training

6 Tips to avoid 483 letters

Posted by Peter Hargittay on Wed, Nov 28, 2018 @ 02:40 PM

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The U.S. Food and Drug Administration (FDA) is authorized to perform random inspections and audits, and these inspections can lead to FDA warning letters and FDA Form 483 observations. Quality managers must take several proactive steps to reduce the risk of warning letters, but what exactly should be done, besides the obvious, which is to be in compliance with defined regulations?  

First, let’s define and understand the meaning of warning letters and Form 483 observations.  Warning letters are considered to be informal and advisory by the FDA.  Nevertheless, organizations are expected to voluntarily comply with the law and to take corrective actions.  The FDA Form 483 provides support for the alleged violation and communicates the concerns discovered during the inspection.

Organizations are given an opportunity to voluntarily and promptly respond in writing and include a corrective action plan.  However, if issues highlighted by the FDA are not addressed and communicated in a timely manner, the FDA will initiate an enforcement action, and these actions can include product recalls, fines, penalties, and, of course, your reputation is at stake.

Here are some tips on how to avoid a warning letter and  form 483 observation:

  1. Be inspection ready

Have a QMS in place that meets your operational needs and compliance requirements, conduct your own internal audits on a regular basis, identify audit team members and assign tasks, provide a schedule of meetings, identify confidentiality requirements, and involve senior management.  Inform your employees about audits, provide resources needed, and appoint staff to accompany auditors when they do arrive.

  1. Clearly Written Standard Operating Procedures

The Standard Operating Procedures (SOPs) need to be clearly and concisely written, but also maintained by getting them modified when necessary. Make sure you document any changes and that only the most recent version is available to your team and to inspectors.  

  1. Proper Document Control

An automated document control system provides proper version control of your documents, including SOPs.  Your document control should eliminate the possibility of human errors and provide standardization to your version control, revision history, and approval process.  Establish proper permissions to prevent unauthorized access and changes to your documents.

  1. Develop a compliance culture

Make quality and compliance a cornerstone of your culture.  A corporate culture is often driven by the organization’s CEO.  You need your CEO and executive team to be on board, and to understand and communicate the importance of compliance and quality to the entire organization.  One way to ensure senior management involvement is to actively involve them in the initial meeting of an audit, during the audit process, and in the final meeting.  Make sure to keep senior management involved with all subsequent communications with the FDA.

  1. Correct observations real-time

Take every effort possible to correct observations while the FDA investigator is still onsite and express that remaining issues are in the process of being addressed, ideally with a stated timeline.  It’s important to communicate these changes or planned changes before or during a close-out meeting, and before the FDA inspection report is completed. Remain professional, provide proof whenever possible, and keep copies of signed-off documents.

  1. A hyper-adaptive Quality Management Software

QMS software has evolved from customizable solutions that are typically expensive, time consuming, and with limited configurability capabilities to quality automation software that empower users with tremendous flexibility and at a lower total cost of ownership.  A modern and hyper-adaptive quality automation solution will ensure compliance today and into the future as you can easily address new business and regulatory changes.

If you want to own your own quality and compliance experience, learn more about Intellect’s comprehensive, integrated and hyper-adaptive eQMS software suite and automation platform.


Tags: 483 Warning Letters, FDA regulations, FDA compliance, FDA, fda standards, Document Control, warning letter

How Employee Training Reduces Nonconformance

Posted by Romeo Elias on Mon, Oct 15, 2018 @ 10:03 AM

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The existence of nonconformance can only mean that something has gone wrong and that a particular set of specifications wasn’t followed. It means that the company’s standard operating procedures (SOP) were not followed, and in a broader term, it means that the requirements set out by ISO 9000 were not met.

When this occurs, it naturally has to be handled. Thankfully, it’s no longer required to document the whole procedure of finding, reporting, and fixing nonconformance issues, so this entire ordeal is a bit easier. But keeping a record of nonconformity and how it was corrected is still necessary.

The things that have to be done to correct the problems can only be done after the problems have occurred. It’s far easier to have measures that will prevent nonconformance issues from appearing altogether.

The easiest way to reduce nonconformance is employee training. Let us explain how to proceed.

The Causes


It’s good to identify the cause first, to find a solution. Whatever the business in question might be, reasons for nonconformity issues can usually be boiled down to the same things:

  • Poor or lack of documentation
  • Poor communication or miscommunication
  • Poor personnel training
  • Poor personnel motivation
  • Dysfunctional operating environment
  • Poor quality or lack of materials
  • Poor quality or lack of tools and equipment

As you can see when taking a better look at the causes, most of them can be, in one way or another, attributed to employee training. Some of them individually are lousy employee training while some others are indirectly or directly connected.

Naturally, it doesn’t mean that you can eliminate nonconformance through employee training, but it indeed is the best way to avoid it in most cases.

How to Achieve the Desired Effects


Proper employee training is vital for several reasons, not only for reducing nonconformance. To achieve quality training, you need to nurture and maintain the knowledge base of your employees and suppliers.

In essence, you need to get all personnel up to speed with several issues: from policies, regulations, SOPs, and many other relevant quality metrics. The baseline is for the achievement of quality, and violations need to stop happening.

It, in turn, can almost eliminate the possibility of nonconformity.

However, achieving quality training is not an easy feat. Plenty of periodic training sessions must be conducted, tests as well, and even awareness programs for all of your personnel, including suppliers. This way you can ensure that everyone in your organization and those connected to it, are on the same page and have the same goal.

The training can also improve motivation of employees through unity. It will enhance communication as well and creates a better operating environment. Also, even documentation can be improved. As we have already said, these are some of the most common causes of nonconformity. They practically eliminate with the improvement of employee training, which will reduce dissent.

Dealing with nonconformity and other quality issues is best achieved through a Quality Management System. Intellect offers an out-of-the-box solution through its eQMS platform that already incorporates workflow in several modules like CAPA, Doc Control, and more.  

Tags: employee training, nonconformance, Training

Supply Chain Risk Management: 5 Different Types

Posted by Romeo Elias on Tue, Oct 02, 2018 @ 10:01 AM

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Supply chain risk, as well as business risk in general, come in many shapes and forms. The risk comes from the most basic everyday processes to some extraordinary circumstances that are often hardly identified.

With all of that being the case, organizations have found several different ways of managing risk, especially in the supply chain. To stay afloat and competitive in the market of the modern world, you need to have an excellent strategy to manage risk. Let’s take a look at some of the ways risk is managed.

The Change Management Process


The change management process should include the suppliers, because this way, you are making sure that they are notified of any change in the design phase. It means that the suppliers can always ensure that their components conform to the new design and are thus able to control the potential risks.

In essence, by doing this, you are making sure that your finished product has factored in both the supplier components and the production process, to ensure quality and reducing potential risks.

Supplier Performance Management


The accountability factor is the main obstacle to the quality in the supply chain. The suppliers have their standards, but if they can’t see your system, they cannot know how you’re rating them.

By having a proper supplier rating system that’s also tied to risk-based methods, you will ensure that your business truly measures the supplier’s performance. It will allow the supplier to see the ratings and they will then improve upon their quality if the grades are not good enough in their eyes. Every supplier wants to improve their quality and be the leading supplier to other organizations, so you can be confident that the rating will affect them.

Out-of-Specification and Non-conformance Management


Often, it can be the case that the components are out of specification. Usually, the business deals with the issue, inform the supplier and moves on. However, by automatically generating nonconformance and advising the supplier of what exactly is out of specification, you are ensuring that there is better collaboration involved.

All of this in effect ensures that both risk and severity of the said risk is reduced.

Corrective Actions


When it comes to managing any systemic issues in the supply chain, the corrective action process is your best solution, because it’s essential that there is a collaborative process that allows the supplier to finish some part of the corrective action.

In essence, it ensures that you are consistently able to improve the finished product, as well as allow the supplier to upgrade the components which are part of that same product.

The Post-Market Reaction


After the product is released, post-market feedback is inevitable. Complaints and a lot more are always a big part of this. If you want to respond to all this feedback adequately, it’s vital that you have all the information about the product. If the supplier is involved all the time, you will have additional information from the supplier as well. It, in turn, allows for better handling of the post-market.


Supply chain risk can effectively be managed with most of the techniques explained here, however, if you want entirely effective risk management that involves all of what we described here, an out of the box QMS solution is your best option. It is because the risk is no longer an isolated part of the Quality Management System, but more a feature of it.

Tags: Supplier Management, supply chain management, Risk Management, supply chain risk management, supply chain, Change Management

Ensuring Quality and Operational Excellence in Labs

Posted by Romeo Elias on Wed, Sep 19, 2018 @ 09:04 AM

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New technologies are bringing transformation to most industries, especially healthcare. With our health systems going through changes caused by stricter compliance requirements and demands for running at peak performance, the weak links of the system are being identified and eradicated.

The lab environment is no different. We live in the time when increasing efficiency of any operation is the primary goal of creating innovative solutions. These solutions in turn help labs optimize their processes and evolve. However, ensuring quality and Operational Excellence in labs is no easy task, and it should be approached with patience and meticulousness. Here’s how a lab can achieve Operational Excellence and ensure quality:

Improving Accuracy

Inaccuracy in any part of the sample testing process can be a massive problem for labs. Since lab work is done in stages, every stage depends on how accurate was the one preceding it. One of the primary goals of any lab should be to cut down on errors during testing, considering the impact they have on the entire process.

It is also essential for labs to define and implement testing sequences that ensure lab tasks are all completed in the same manner, and at the same time in order. It helps make them more reliable and predictable, which are all attributes that go hand-in-hand with accuracy.

Improving Efficiency

Efficiency is such a broad issue that any area of the lab could have small (or huge) efficiency problems. To weed these issues out, you need to be aware of how all processes are being carried out and then evaluate how successful they are. Some of the usual inefficiency-related problems are wasted motion, overproduction, transportation, waiting, defects, inventory, and over processing.

Fixing these issues requires careful analysis, as well as developing an automated approach that addresses the most common inefficiency problems and neutralizes them. An automated workflow solution can be useful as it helps organizations by clearly showing where the hold-ups in the process are.

Improving Speed

While accuracy and efficiency are essential, speed is the one aspect of achieving Operational Excellence that seals the deal. By developing a streamlined process that ensures logistics are reliable and that specimens are accurately labeled, it’s possible to speed up the process. It helps clinicians begin patient care and treatment faster.

As you level the load and drive flow, you ensure that samples that arrive are tested as quickly as possible. Once you manage to consistently keep work flowing through the lab by leveling workload, and reduce throughput time by doing so, you’ll manage to improve the speed of the entire process.


Managing Quality

Achieving Operational Excellence by improving the efficiency, speed, and accuracy of lab processes has an added benefit of also making them compliant and creating a better quality assurance system. The ultimate goal of a lab when it comes to ensuring quality, as well as Operational Excellence, is to eliminate errors and create a reliable process. It is naturally in line with FDA expectations and best practices of the industry. Using QMS solutions with workflow automation and the ability to work in different modules helps quality assurance and brings it up to OE standard.

With Intellect QMS solutions, your lab can operate on the highest level of speed, efficiency, and accuracy. It ensures you’ll be able to both reach Operational Excellence and maximize quality assurance standards with careful implementation of industry best practices through QMS.

Tags: operational excellence, labs, quality, Quality Management Software, quality data, Quality Management System

How an Effective Workflow Helps You Improve Your Business

Posted by Romeo Elias on Thu, Sep 06, 2018 @ 09:18 AM

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Among the factors that affect how quickly a business will grow; one of the most important ones is undoubtedly efficiency. For example, there is a clear difference between companies that use paper-based processes and those that are entirely digital. To improve business, you need to have a streamlined process that ensures quality, and that is also easy to use at the same time.

One solution for improving your business process management is undoubtedly using workflows. An effective workflow helps you grow your business by providing the framework through which all tasks are done. Let’s have a look at what right workflow solutions can do for a company and how they are used in quality management systems.

What Is a Workflow?

Simply put, a workflow is the way employees get work done. It’s usually presented as a diagram or checklist containing a series of tasks that need to be completed sequentially. A workflow can be as complicated or as simple as you make it, but its purpose is to make work easier. Once all the tasks are laid out in a visually engaging manner, employees can go through them and check them off one by one.

It also allows managers to oversee the work process in real time. Workflows make it possible for managers to be notified of any delays as well, and with them, it’s easier to ensure every employee is following the company standards of work.

The Impact of Workflow Automation

Businesses that implement workflow automation gain the clear insight into the work process itself. That can have an instant and noticeable impact on the organization’s efficiency. The best part is that once automation is set up and all the roles, approvals, decisions and steps are defined, there’s no need to spend time setting up new workflows each time. In case of the process change, you can update the workflow to reflect the changes with a few clicks.

Business Improvements Brought on by Workflows

The benefits of gaining better insight into your organization’s business process management and making it streamlined are numerous. Employees will work faster as it will be easier to manage the inevitable delays and roadblocks. It’s going to make the collaboration of multiple people on a project much less stressful. All of this directly influences the overall performance of an organization. It also improves your quality management process, as some QMS solutions have automated workflow features.

Benefits of a QMS Solution with Workflow Automation

A QMS solution is a powerful tool since it can ensure business optimization through quality improvements and saving costs. However, an out of the box QMS solution that also incorporates workflow automation in modules such as Doc Control and CAPA can make all the difference when it comes to improving your business’ efficiency. With Intellect’s QMS solution, you don’t have to develop your workflow, although it’s an option — you can use existing ones or customize them.

Visit our website for more information about Intellect’s QMS solutions and how they help you streamline your business management process to improve your business.

Tags: workflow automation, Hosted workflow Solution, Workflow and Business Process Management, Workflow, Workflow Managment, Workflow Process Management

Food Industry: Ensuring Quality and Operational Excellence

Posted by Romeo Elias on Thu, Aug 16, 2018 @ 02:41 PM

 

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Striving for Operational Excellence is nothing new to both leaders and followers in the food industry. Still, given the industry’s unique characteristics, finding a way to accomplish it can be a difficult feat for a company.

Any food industry enterprise often finds itself at the mercy of global commodity markets. Once you account for other difficulties such as high demand variability and low margins, it becomes clear why achieving Operational Excellence is a challenge. However, there are ways to ensure both quality and Operational Excellence in the food industry. Here are the things you should keep in mind:

Optimizing Your Manufacturing Process

You can’t achieve Operational Excellence without having a firm hold on your manufacturing process, and that starts with controlling your data. The only way to optimize the process is through data collection and analysis — the more automated this process is, the better. To this end, do away with paper-based systems and digitize them instead. You’ll feel the positive impact of this change throughout your entire organization. There are plenty of benefits to enjoy, from making it easier to demonstrate compliance with quality standards, to being able to trace your metrics a lot more reliably.

Keeping Up with Compliance Standards

With digitizing your enterprise comes the ability to track your implementation of compliance standards. It is important because it gives you some useful insights into how you can improve the quality of your products. It’s always better to address compliance standards early on, instead of running afoul of them and having to correct course. It keeps customers happy and prevents possible financial consequences.

Becoming Able to Save the Day

In case of an unwanted event related to non-conformance to compliance standards, you need to be able to react quickly. Especially in the food industry, any product can become the victim of a quality issue. It leads to costly recalls and damaged brand reputation. To prevent this, you need to be able to catch compliance issues before they become a huge problem. With automated workflows that can manage compliance issues before they escalate, you can avoid the brunt of the blow.

Learning How You Affect the Environment

Another thing that could become a problem is the sustainability costs. If you wish to have a clear picture of how much your operations cost, you can’t forget to include sustainability costs when measuring your KPI. Once you have the data, you can analyze it to see if it’s possible to improve the efficiency of your manufacturing process by reducing some of the costs. Use sustainability information along with your general production data to truly understand its impact.

Implementing Enterprise Systems

The right tools can be of immense help in your quest to achieve Operational Excellence. Use them to create a lasting foundation for conducting all your processes and improving collaboration while breaking down the silos in your organization. Enterprise systems like ERP and QMS can integrate and synchronize all the systems and methods in your organization to create a single, strong value chain.

Here at Intellect, we have an out of the box eQMS solution that can help you do it. Let go of outdated processes and achieve Operational Excellence by driving success with collected data and automation.

Tags: FDA regulations, food industry, mobile compliance, Compliance, manufacturing

Digital Transformation: Why Is It Important for Quality?

Posted by Romeo Elias on Mon, Aug 06, 2018 @ 01:03 PM

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With the advancement of technology, more and more businesses are opting to undergo a digital transformation. It’s understandable, as it improves core business functions by making them more efficient.

However, there’s more to digital transformation than using apps that speed up a company’s processes. Innovation is an integral part of it — everyone wants an advantage over the competition which digital technologies might provide. Still, what all businesses need to understand is that digital transformation is also significant for Quality, and here’s why:

Shared Customer-Centric Focus

The end goal of digital conversion or any other IT initiative is improved end-user experience. Quality Assurance shares this focus as it aims to preserve good corporate reputation. However, that’s not the only goal of Quality Assurance — other than consistently good IT service and security for all users, QA needs to worry about the seamless launching of products and services. Staying ahead of the competition is crucial, but not at the cost of sufficient assurance of quality.

Importance for Innovation

There has been some discussion on what counts as “true” digital transformation. CIOs often merely digitally optimize their business, but they don’t transform it and innovate. It’s of paramount importance to have a good business vision when it comes to digital transformation, which is usually disruptive to the business or industry. Without QA to ensure business outcomes and a high level of customer value, that becomes even harder to accomplish.

Quality Challenges in Digital Transformation

Digital transformation covers plenty of different areas such as omnichannel solutions, IoT, and devices, mobile solutions, big data and analytics solutions, cloud services, etc. QA needs to adapt in all of these areas and provide the best customer value by focusing on eliminating some of the known weak points of each area.

For example, with mobile solutions, quality would have to work on improving the security and performance, while increasing functionality and making it all more straightforward to use than it’s ever been. To do this efficiently, QA would have to be able to test its solutions extensively — and that requires tools and expert staff.

How QA Can Meet a Company’s Digital Transformation Needs

Every QA strategy ultimately focuses on improving the end-user experience, which is what digital transformation is all about. However, working towards the same goals may not be enough. Business would still have to invest more funds into QA for it to keep up with the ever-increasing demands of IT advancement. Security and integration testing need to become a continuous practice, especially during the early stages of developing a system or software.

EQMS as a Way to Improve QA

A right way of ensuring that QA does a consistently good job throughout the entire process is using an eQMS to back up your digital transformation system. Despite the potentially high costs, if an eQMS is implemented well, it could make the process of digital transformation easier and improve your bottom line.

Our very own Intellect eQMS can quickly adapt to your company’s unique digital transformation needs. It’s an out of the box solution that can keep your workflow intact while making it possible for you to smoothly go through your digital transformation process and keep your QA on a high level.

Tags: digital transformation, quality challeneges, quality, eqms, Quality Management Software, Quality Management System, QMS

3 Compliance Issues That Can Be Solved By Automation

Posted by Romeo Elias on Mon, Jul 16, 2018 @ 01:31 PM

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For compliance managers in any industry, it’s imperative to provide tools and practices for a company-wide commitment to quality. Whether the industry is construction, government, education, healthcare or manufacturing, there are usually plenty of different compliance regulations to meet.

In that kind of a corporate climate, being as efficient as possible at ensuring compliance can be a significant time-saver. Not only that, but efficiency at implementing some of the necessary compliance solutions can ensure that human error has been reduced to a minimum. And in today’s environment of technological advancement, efficiency is often the synonym for automation.

Automating compliance processes is something any company can benefit from, regardless of the industry. Still, automation is beneficial for those organizations that need to comply with ISO and FDA quality standards. Let’s have a look at three compliance issues that can be solved by automation:

Staying on Track with Quality Objectives

Automation of quality management doesn’t only mean that it will be easier to complete compliance and quality management processes in the technical sense. It also helps everyone in the organization be aware of the organization-wide quality objectives. Losing sight of them makes for inconsistent employee performance, and the organization might fail at building a culture around compliance and quality.

Since quality standards and goals are visible to everyone in an automated system, it makes it easier for the employees to meet them. And, in the case of collaboration with external teams, it ensures that the same quality standards will apply to them.

Corrective And Preventive Actions (CAPA)

CAPA is an integral part of any automated QMS, and it’s crucial to staying within compliance standards. In case of any undesirable events, the CAPA can help identify its cause. After that, it’s only a matter of prevention and coming up with a plan that won’t let it happen again. A procedure that helps set everything back on track is necessary. By having an automated solution that handles it, everyone in the organization will be aware of how best to handle any unwanted situation and resolve it quickly.

Document Control

An automated system creates a centralized hub for all organization-related activity. And when it comes to daily functions of an organization, document control is one of the most critical processes. Without a well-organized document control system, you’re inviting chaos into your organization (and most likely inspection as well.) Since FDA-regulated and ISO-certified companies are required to have a document control system, it’s clear to see how problems in this area can affect the whole company. Keeping up with audits and making sure that all necessary documents are created, stored and shared according to the company’s quality standards helps maintain a team that’s more accountable and informed. Therefore, automating document control can significantly improve an organization, not only with compliance but with the day-to-day operation as well.


Today’s business revolves around complex rules and regulations. To ignore any of them is a fatal mistake, but to comply most efficiently, you need a staunch ally. An automated compliance solution that can meet your company’s unique needs could be the difference between success and failure.

With Intellect’s QMS solution, you don’t have to develop your workflow unless you want to customize the existing ones. It works out of the box and makes sure you have an easy time automating your organization’s quality management and compliance processes.

Tags: automated solutions, business automation, workflow automation, iso compliance, laboratory compliance, FDA compliance, mobile compliance, Compliance, CAPA, Document Control

Best Risk Management in Laboratories

Posted by Romeo Elias on Wed, Jul 11, 2018 @ 09:32 AM

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In many industries, companies seek to improve their manufacturing and product development and have to go through many regulatory reforms to do so. They require them to adopt quality systems standards which reduce risk.

Clinical laboratories don’t find themselves often in front of similar legal challenges because patients are required to give written consent, and acknowledge that their therapy involves a certain level of clinical risk. Still, risk management in a laboratory environment has become necessary due to the evolution of quality systems requirements. For best risk management in laboratories, consider these practices:

Risk Identification

Testing and quality activities conducted in laboratories have documented vulnerabilities. The most common causes of error are in the pre-preanalytical and post-analytical phases of the testing process.

These include possible errors with order entries, various sample collection errors and inappropriate handling or storage, as well as incorrect interpretation or delayed reaction to laboratory reporting. Laboratories can sometimes struggle to implement even the subtlest changes in policy or practice because it makes the overall performance prone to failures. It’s essential to identify risks in a lab’s testing process and work on preventing them. Laboratories usually deal with this through a traditionally-oriented QC approach, but that’s not always effective.

Quality Management System for Laboratories

Laboratories aren’t free from having to address all aspects of a corporate quality management system. It’s necessary for them to maintain standard operating procedures and implement control measures that can identify potential risks to the system.

ISO 15189 guides laboratories when it comes to technical and quality requirements. Laboratories must be able to record performance data and audit the results of the system, among other things. Correction and prevention of any issues that might arise from using closed-loop processes to document procedures are also paramount.

Risk Management Plan Definition

A risk management plan is crucial for the lab’s quality management plan. Each laboratory can incorporate technical requirements for testing processes into its quality management system differently. Therefore, it’s important to understand how these work to assess the effectiveness of a laboratory approach to risk management. The litmus test for this is the lab’s ability to match its planned objectives to its actual activities. If a laboratory’s execution of its TTP, IQCP or QC plan employs risk-based thinking, that’s a useful approach.

Risk Assessment and Management

In assessing and managing risk, laboratories need to keep track of all the various testing scenarios and outcomes. Once labs can understand their planning and confirm it, they’ll know which measures they need to take to deal with an unwanted result. A risk-management solution that integrates with the lab’s existing QMS could be quite useful. With it, labs could capture, communicate and address all their risk-related documentation and activities. Learning to prevent risk issues is essential. Laboratories need to be able to track risk management issues and manage their risk reporting system efficiently.

Empower your lab staff to make smarter and safer risk-related decisions by using the risk-management software. A standardized system that can fit your unique requirements can be valuable for all aspects of a laboratory’s testing and quality management plan.

Tags: Risk Management, labs, risk identification, laboratory compliance, ISO, iso compliance, risk assessment