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How can you ensure complete and accurate GMP quality audit reports?

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GMP quality audit reports are essential documents that demonstrate the compliance and performance of a manufacturing facility, process, or product. They provide evidence of the audit scope, objectives, findings, and recommendations, as well as the corrective and preventive actions taken or planned. However, writing a complete and accurate GMP quality audit report is not a simple task. It requires careful planning, execution, and follow-up, as well as a clear and consistent format and language. In this article, we will share some tips on how to ensure that your GMP quality audit reports meet the expectations of the auditors, regulators, and stakeholders.

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Rozil Anwar B.E, MBA, Harvard Business School Leadership

Global Leader in Strategic Operations & Business Transformation | Award-Winning Innovator Driving Excellence Across…
Sreeja Sreekumar

Associate Director, Quality Operations |M.S.| CQA|- Morphosys ( Novartis Company )

1 Plan ahead

Before you start writing your GMP quality audit report, you need to have a clear plan of what you want to achieve and how you will do it. You should define the audit scope, objectives, criteria, and methodology, as well as the roles and responsibilities of the audit team and the auditee. You should also prepare a detailed audit checklist, schedule, and agenda, and communicate them to the relevant parties. Planning ahead will help you avoid confusion, duplication, or omission of information, and ensure that your report covers all the relevant aspects of the audit.

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Rozil Anwar B.E, MBA, Harvard Business School Leadership

Global Leader in Strategic Operations & Business Transformation | Award-Winning Innovator Driving Excellence Across Industries | International QHSE & Organizational Leadership Expert
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In my extensive audit experience the best audit approach is to align audits to Objectives/ KPI, international compliance or output oriented. Always formulate a checklist and audit report format in advance. Keep audit checklist short and simple. Repeat audits once a quarter but keep it simple with not more than 10 questions.

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Sreeja Sreekumar

Associate Director, Quality Operations |M.S.| CQA|- Morphosys ( Novartis Company )
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To ensure complete and accurate quality audit reports, we should consider the following steps: 1. Clear definition of the scope 2. Develop a detailed audit plan that outlines the methodology, resources required, and timeline. 3. Execute the audit by collecting and analyzing data, conducting interviews, reviewing documentation 4. Record all findings accurately and comprehensively. 5 Analyze the findings to identify trends, patterns, and areas of concern. 6. Validate the observations with relevant stakeholders 7. Prepare a clear and concise report 8. Before finalizing the report, conduct a thorough review 9. Once approved, distribute the report in a timely manner. 10. Monitor the implementation of recommendations

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2 Follow the format

A GMP quality audit report should follow a standard format that includes the following sections: title page, executive summary, introduction, audit findings, audit conclusions, recommendations, appendices, and references. Each section should have a clear and concise title, subheadings, and numbering system. You should also use consistent fonts, margins, spacing, and alignment throughout the report. Following the format will help you organize your information, present it in a logical and coherent manner, and facilitate the review and approval process.

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3 Use clear language

A GMP quality audit report should use clear and precise language that avoids ambiguity, jargon, or slang. You should use active voice, simple sentences, and bullet points whenever possible. You should also use correct grammar, spelling, and punctuation, and proofread your report for errors. You should avoid subjective or emotional statements, opinions, or assumptions, and instead focus on facts, evidence, and data. You should also use consistent terminology and definitions, and explain any acronyms or abbreviations. Using clear language will help you convey your message, avoid misunderstandings, and demonstrate your professionalism.

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Rozil Anwar B.E, MBA, Harvard Business School Leadership

Global Leader in Strategic Operations & Business Transformation | Award-Winning Innovator Driving Excellence Across Industries | International QHSE & Organizational Leadership Expert
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In my auditing experience its imperative to use simple language which reader of report can understand. Keep it short and simple. Traffic red lights -visual management system can also be used in audit report summary.

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4 Provide evidence

A GMP quality audit report should provide evidence to support your audit findings, conclusions, and recommendations. You should cite the sources of your information, such as documents, records, interviews, observations, or tests. You should also include relevant data, such as numbers, percentages, graphs, or charts. You should use objective and verifiable criteria, such as standards, regulations, or guidelines, to evaluate the compliance and performance of the auditee. You should also document any deviations, nonconformities, or risks that you identify during the audit. Providing evidence will help you justify your conclusions, demonstrate your credibility, and enable the auditee to take appropriate actions.

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Rozil Anwar B.E, MBA, Harvard Business School Leadership

Global Leader in Strategic Operations & Business Transformation | Award-Winning Innovator Driving Excellence Across Industries | International QHSE & Organizational Leadership Expert
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Audit is a fact finding exercise and not a fault finding. Report must be based on objective evidences. Thoughts/ mindsets/ views shall not be part of audit report.

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5 Follow up

A GMP quality audit report is not a final document that you can forget once you submit it. It is a dynamic document that requires follow-up actions and feedback. You should communicate your report to the auditee, the auditor, and any other relevant parties, and solicit their comments, questions, or suggestions. You should also monitor the implementation and effectiveness of the corrective and preventive actions that you recommend or agree upon with the auditee. You should document any changes, updates, or revisions that you make to your report, and keep a record of the audit history and status. Following up will help you ensure that your report is accurate, complete, and up to date, and that it achieves its intended purpose and outcomes.

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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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How can you ensure complete and accurate GMP quality audit reports?

1

2

3

4

5

6

1 Plan ahead

2 Follow the format

3 Use clear language

4 Provide evidence

5 Follow up

6 Here’s what else to consider

Quality Management

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How can you ensure complete and accurate GMP quality audit reports?

1

2

3

4

5

6

1 Plan ahead

2 Follow the format

3 Use clear language

4 Provide evidence

5 Follow up

6 Here’s what else to consider

Quality Management

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