How can you handle incomplete or incorrect GMP documentation?

1 Identify the root cause

The first step to handle incomplete or incorrect GMP documentation is to identify the root cause of the problem. This can be done by using various tools and techniques, such as the 5 Whys, fishbone diagrams, or failure mode and effect analysis (FMEA). The root cause analysis should involve the relevant stakeholders, such as the document authors, reviewers, approvers, and users, and consider the human, technical, and organizational factors that may have contributed to the error or omission. By identifying the root cause, you can avoid blaming individuals and focus on finding solutions.

2 Correct and complete the documentation

The next step is to correct and complete the documentation as soon as possible, following the established procedures and guidelines for document control and change management. Depending on the nature and severity of the error or omission, you may need to initiate a deviation, a nonconformance, or a corrective and preventive action (CAPA). You should document the rationale for the correction or completion, the evidence of the change, and the approval of the authorized person. You should also ensure that the corrected or completed documentation is distributed and accessible to the intended users and that any obsolete or superseded versions are removed or archived.

3 Train and educate the staff

Another important step is to train and educate the staff on the importance and requirements of GMP documentation and records. You should provide regular and refresher training on the applicable standards, regulations, policies, and procedures for document creation, review, approval, distribution, retention, and disposal. You should also explain the consequences and impacts of incomplete or incorrect GMP documentation on the product quality, customer satisfaction, and regulatory compliance. You should assess the effectiveness of the training by conducting quizzes, tests, or audits and provide feedback and coaching to the staff.

4 Monitor and improve the process

The final step is to monitor and improve the process of GMP documentation and records management. You should establish and use key performance indicators (KPIs), such as the number, frequency, and type of errors or omissions, the time and cost of correction or completion, and the customer and regulatory feedback. You should also conduct periodic reviews and audits of the process and identify any gaps, weaknesses, or opportunities for improvement. You should implement and evaluate any improvement actions and ensure that they are aligned with the quality objectives and strategy.

By following these steps, you can handle incomplete or incorrect GMP documentation effectively and efficiently and improve your quality management system and performance.

5 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?