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What are effective ways to follow up on GMP quality audit findings?

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GMP quality audits are essential for ensuring compliance, safety, and quality in the pharmaceutical, biotechnology, and medical device industries. However, conducting an audit is only half of the process. The other half is following up on the audit findings and implementing corrective and preventive actions (CAPA) to address any gaps or issues. In this article, you will learn some effective ways to follow up on GMP quality audit findings and ensure continuous improvement.

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1 Define the scope and objectives of the follow-up

The first step in following up on GMP quality audit findings is to define the scope and objectives of the follow-up. This means identifying the audit criteria, the audit scope, the audit objectives, and the audit report. The follow-up should focus on the areas that were audited and the findings that were reported. The objectives of the follow-up should be aligned with the audit objectives and the quality policy and goals of the organization.

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Mehreen Fayyaz

Assistant Manager Quality Assurance @ SAMI Pharmaceutical | QMS | X-AGP | PharmD. | MBA - SCM | IoBM
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First of all, prioritize the findings based on their risk and/or category of observation. Next, develop a plan outlining clear corrective actions for each identified issue. Assign responsibilities and set realistic timelines to ensure progress. As communication plays a vital role; keeping all stakeholders informed throughout the process ensures alignment. Additionally, providing training and education to prevent future occurrences is also essential. Remember to meticulously document all actions taken and schedule a follow-up audit to validate their effectiveness.

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Ahsan Shaker

QC Manager at Kohinoor Pharmaceuticals & Surgicals
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In this matter, one needs to realize that its not about immediate action for a non-conforming work, its about follow-up for a NC work that already had occured and CAPA has been generated for it. To evaluate the effectiveness of CAPA or to make follow-up effective, we need to recalculate the risk priority number (RPN). A decrease in RPN will show the effectiveness of CAPA.

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Shane Hark

Quality Assurance, Regulatory Compliance, AI Integration
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To follow up on GMP quality audit findings effectively: 1. Immediate Rectification: Quickly address critical issues to minimize risk. 2. Analyze Causes: Investigate to find the root causes of findings. 3. Action Plans: Develop corrective actions with clear timelines. 4. Educate: Update training to prevent future issues. 5. Monitor Progress: Regularly check the implementation of actions. 6. Record Keeping: Document all steps for transparency and improvement. This ensures compliance, addresses deficiencies, and enhances continuous quality improvement.

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2 Review the audit report and findings

The next step is to review the audit report and findings in detail. The audit report should provide a clear and concise summary of the audit results, including the audit scope, the audit criteria, the audit methodology, the audit evidence, the audit findings, and the audit conclusions. The audit findings should indicate the nature and extent of any nonconformities, deviations, or observations that were identified during the audit. The audit report should also include any recommendations or suggestions for improvement.

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Robert Wixey

Quality Professional
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Reviewing previous audit reports is standard practice for the audit team as they prepare for a scheduled audit. Monitoring and measuring of product and process, monthly performance matrix and management review presentations are also good tool in determining areas to focus on during the audit.

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3 Classify and prioritize the audit findings

The third step is to classify and prioritize the audit findings according to their severity, impact, and risk. The audit findings should be categorized into critical, major, or minor nonconformities, deviations, or observations, depending on the level of deviation from the audit criteria and the potential consequences for the product quality, patient safety, or regulatory compliance. The audit findings should also be prioritized based on their urgency, complexity, and feasibility of resolution.

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4 Assign responsibilities and deadlines for CAPA

The fourth step is to assign responsibilities and deadlines for CAPA to address the audit findings. CAPA is a systematic process of identifying, analyzing, resolving, and preventing the recurrence of quality problems. CAPA should involve the following steps: root cause analysis, action plan development, action plan implementation, action plan verification, and action plan effectiveness evaluation. The responsibilities and deadlines for CAPA should be clearly defined and communicated to the relevant personnel and stakeholders.

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5 Monitor and track the progress of CAPA

The fifth step is to monitor and track the progress of CAPA and ensure that the actions are completed within the agreed timeframes and according to the specified requirements. The progress of CAPA should be regularly reported and documented using appropriate tools and methods, such as CAPA logs, dashboards, or status reports. The progress of CAPA should also be reviewed and validated by the auditors, the auditees, or an independent party, depending on the type and level of the audit findings.

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6 Evaluate and document the results of CAPA

The sixth and final step is to evaluate and document the results of CAPA and verify that the audit findings have been effectively resolved and prevented from recurring. The evaluation of CAPA should involve the following activities: checking the evidence of CAPA completion and compliance, assessing the impact and effectiveness of CAPA on the quality system and processes, and identifying any lessons learned and best practices for improvement. The results of CAPA should be documented and communicated to the relevant personnel and stakeholders, and used as inputs for future audits and quality reviews.

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Michael Kuehne

Principal with ComplyFDA.com
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CAPA effectiveness is related to correcting/resolving the root cause(s) identified as part of the CAPA process. Implementing specific metrics for root cause resolution facilitates ensuring the issue is effectively resolved. For example, training and re-training risks a larger issue with the training program and training effectiveness.

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Merlin Geo

Transformational and Strategic Leader with over 28 years of proven track record in efficiency improvements through Innovation, Digital shifts and People Power. Experienced in Plantation Operation & Manufacturing. Ex MRF
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CAPA effectiveness monitoring is important to ensure that the gaps identified in the audit are addressed and prevented. The documents prepared in line with CAPA is a part of the standardization process and this ensures a regular follow up and improvement. Documentation is always important to ensure compliances and effective verification processes.

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7 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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Judy S.

Retired. My opinions are my own
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The concept of a Process Owner works very well. Quality organization should not be accountable for audit CAPA.There should be a Process Owner for each Process in a Quality Management System. Example , audit findings for manufacturing needs to belong to someone in a manufacturing role who has authority as well as accountability for resources needed to address CAPA. Then the CAPA Process Owner should have a systematic method to capture activities to address audit findings. There should be a CAPA dashboard to include audit findings, person responsible, resources assigned, actions to be taken, implementation timeframe & plan for sustaining corrections & improvements. The CAPA dashboard should be presented to Senior Management periodically.

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What are effective ways to follow up on GMP quality audit findings?

1

2

3

4

5

6

7

1 Define the scope and objectives of the follow-up

2 Review the audit report and findings

3 Classify and prioritize the audit findings

4 Assign responsibilities and deadlines for CAPA

5 Monitor and track the progress of CAPA

6 Evaluate and document the results of CAPA

7 Here’s what else to consider

Quality Management

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What are effective ways to follow up on GMP quality audit findings?

1

2

3

4

5

6

7

1 Define the scope and objectives of the follow-up

2 Review the audit report and findings

3 Classify and prioritize the audit findings

4 Assign responsibilities and deadlines for CAPA

5 Monitor and track the progress of CAPA

6 Evaluate and document the results of CAPA

7 Here’s what else to consider

Quality Management

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