Quality assurance (QA) is a process that helps a business ensure its products or services meet the quality standards set by the company or its regulatory requirements. QA is involved in all stages of a product’s development, from raw material delivery through manufacturing to packaging and delivery, and it is different from Quality control (QC), which focuses on detecting errors or bugs in the product itself. QA engineers are responsible for testing, creating standards, and developing plans to ensure quality. 

QA is most companies’ last line of defense. QA’s job is to ensure that top quality is met at every stage, and QA will be the last department to review a document for approval. In safeguarding that all documents are prepared correctly and compliant, products can be compliant and ready for consumer use. Documentation review can sometimes be daunting, but here are a few questions to ask yourself when reviewing a document.  

Is the document ready for QA review? 

QA should be the last to review and sign for approval for Good Document Practices (GDP) after the corresponding departments have reviewed and approved the documents.  Whether the document is an Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) or a final report, QA should be the last to review it. Sometimes in the execution of the document, this might be forgotten, so before reviewing a document, make sure that every other department has had a chance to view and approve of the document before QA does. This ensures that whatever QA approves is the final version that complies with company and regulatory agency standards.  

Do you understand the document? 

 When reviewing a document as QA, it is important that you have a general understanding of the document’s purpose.  For example, if the document is requalifying equipment, make sure you understand what equipment is being requalified, and if you do not know, then ask questions to get a better understanding of the equipment’s purpose. Use your Standard Operating Procedures (SOP) as references for any document that you are reviewing. Any update on a SOP or governing document must be reflected on any document under it. Once you understand the document’s purpose, you can review and verify the information on the document is correct and better assess if any clarifications or edits need to be made.  

Are there any deviations that still need to be addressed? 

As QA, most deviations that arise during the execution of protocols will have already been presented to you and signed off by the affected departments. During QA review, sometimes issues arise, or you will spot something that needs to be addressed. It is QA’s job to determine whether it is a deviation or not. Refrain from second-guessing yourself if you think there is a deviation, ask for help to ensure that it gets taken care of in compliance with your company. Also, if more information is needed, always go to the document owner, and ask questions. You can always have Insufficient information and most of the time any issues that might have come up during review can get resolved without the need for deviations.  

Is the document complete?

This is one of the most effortless corrections in any protocol. Believe it or not, sometimes pages go missing, signatures need to be there, or boxes need to be filled in. Whatever the case may be when reviewing documents, ensure that the document is complete. Look to make sure every page is there and, if not, that there is some justification for it. This also means ensuring that every signature has been included. It is easy for different departments to miss a signature. Small items like this typically get taken care of when the other departments are reviewing the document, but sometimes it can slip, and it’s QA’s job to ensure the document is complete before signing off.
 

Are the acceptance criteria met?

This is where QA must be at its most vigilant. Acceptance criteria are essential, not only for company standards but for regulatory agency standards. Failing to meet these can bring many issues and penalties, not just from within the company. It can lead to fines and penalties from regulatory agencies. When reviewing acceptance criteria, always double-check and ensure they have been met and the corresponding evidence backs it up. Sometimes protocols can be executed so often that it’s assumed that the acceptance criteria have been met. Still, it is QA’s job to always review the data and evidence to ensure that the requirements have been met. It might seem unlikely that something has been missed but always double-check because this ensures that the product or equipment meets all predetermined standards for its use. Always check the acceptance criteria to its governing SOP. Sometimes a protocol might be executed with outdated acceptance criteria, but it is pertinent that the most recent acceptance criteria are met. If something is found in the acceptance criteria, take the proper steps to ensure it is properly investigated.  

Conclusion  

Much more goes into reviewing documents in the QA department, but hopefully these tips can help you ensure that every document is reviewed to the highest of standards. PSC Biotech® have highly trained QA consultants who can help your company with all your quality needs. Quality documentation review is essential for ensuring compliance, accuracy, and efficiency in your projects.

Get quality documentation for your biotech projects with PSC biotech

If you want to learn more about improving your quality documentation review process, please contact us today. And if your organization is a Biotechnology Innovation Organization (BIO) member or a member of one of the state affiliates, you are eligible for significant savings on our professional services consulting.

Contact our experts today at sales@biotech.com to discover how PSC Biotech can help you achieve precision, reliability, and trust in your testing and calibration processes.

Similar Posts