Last updated on Feb 2, 2024

How often should you review your lab protocols?

Lab protocols are the backbone of any scientific research or testing. They provide the guidelines, procedures, and standards for conducting experiments, ensuring quality, safety, and reproducibility. But how often should you review your lab protocols to make sure they are up to date, accurate, and compliant? Here are some factors to consider when deciding on the frequency and scope of your lab protocol reviews.

1 Regulatory requirements

One of the most important reasons to review your lab protocols is to comply with the regulatory requirements of your field, industry, or institution. Depending on the type and purpose of your lab, you may need to follow specific rules and regulations from local, national, or international authorities, such as the FDA, EPA, OSHA, or ISO. These regulations may change over time, so you need to stay informed and update your protocols accordingly. You should also document your protocol reviews and any changes you make to demonstrate your compliance and accountability.

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Kengia Kengia

Lab Scientist | QA & QC
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The frequency with which you should review your lab protocols depends on several factors, including the nature of the experiments, the stability of the protocols, and any changes in equipment or personnel. However, as a general guideline, it's advisable to review and update your lab protocols regularly.

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2 Technological changes

Another factor that may affect your lab protocols is the advancement of technology. New equipment, software, methods, or materials may become available or obsolete, requiring you to modify or replace your protocols. Technology can also improve the efficiency, accuracy, or quality of your lab processes, so you may want to adopt new innovations or best practices that suit your needs and goals. You should monitor the technological trends and developments in your field and evaluate how they impact your lab protocols.

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Ricardo Sternberg

Regulatory Affairs and Quality Control Manager en SK Pharma
(edited)
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Sometimes the change may impact the MoA in many ways. For example, a complete new product or API monograph may become official with newer requirements for (% impurities or limit of Nitrosamines) specifications shifting from HPLC to UPLC. This may trigger a new change request for the update, validation and or tech transfer and change closure. In this sense, the R+D team must be online with the latest requierements on the available official literature.

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3 Staff feedback

A third factor that can influence your lab protocol reviews is the feedback from your staff. Your lab personnel are the ones who execute your protocols on a daily basis, so they have valuable insights and suggestions on how to improve them. You should encourage your staff to report any issues, challenges, or errors they encounter with your protocols, as well as any ideas or solutions they have. You should also solicit their input and opinions on your existing or proposed protocols, and involve them in the review process. This way, you can enhance your lab protocols while fostering a culture of collaboration and communication.

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4 Performance indicators

A fourth factor that can help you decide how often to review your lab protocols is the performance indicators of your lab. These are the metrics or measures that reflect the quality, efficiency, or effectiveness of your lab processes and outcomes. For example, you may use indicators such as turnaround time, accuracy rate, error rate, customer satisfaction, or cost reduction. You should track and analyze these indicators regularly and compare them with your goals and expectations. If you notice any gaps, deviations, or trends, you may need to review your lab protocols and identify the root causes and possible solutions.

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Ricardo Sternberg

Regulatory Affairs and Quality Control Manager en SK Pharma
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The number of NonConformances, Deviations, OOS/OOT can be used as KPI to estimate the status of the quality the system. Scheduled meetings for the major staff for evaluation of they ocurrence may help to over come the under performing Processes and involved SOPs or to evaluate change of the impacted process.

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5 Review schedule

Based on the factors mentioned above, you can determine how often you should review your lab protocols. There is no one-size-fits-all answer, as different labs may have different needs and priorities. However, a general guideline is to review your lab protocols at least once a year, or more frequently if there are significant changes or issues in your regulatory, technological, staff, or performance aspects. You should also establish a clear and consistent review schedule and procedure, assign roles and responsibilities, and document your review activities and outcomes.

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Ricardo Sternberg

Regulatory Affairs and Quality Control Manager en SK Pharma
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One of the FAQ in an Audit stands on the review period of protocols. As for my experience, some quality systems demand to be updated every 3 years or 5 years by default. Exceptions are made having a change request prompting for an impact in certain SOPs. In some cases the protocol may not need a change. However, compliance indicates that in such cases the protocol must be updated only in the version number and the effective date.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Mariëlle Wouters

MaterialsXpert and Director at MaterialsXpertise
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Depending on your project you need to adapt a protocol and have it reviewer by a colleague. In general it is important to keep the basics up to date to the latest version of items to be used. It is always very learnful to invite 'an interested outsider' to review the protocol (new or existing), to check whether it is clear and written well.

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How often should you review your lab protocols?

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1 Regulatory requirements

2 Technological changes

3 Staff feedback

4 Performance indicators

5 Review schedule

6 Here’s what else to consider

Laboratory Management

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