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What documents should you review to ensure a successful quality audit?

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A quality audit is a systematic and independent examination of a project, process, or product to verify that it meets the standards and requirements of the customer, the organization, and the industry. A successful quality audit can help you identify gaps, risks, and opportunities for improvement, as well as provide feedback and recommendations for corrective and preventive actions. To prepare for a quality audit, you need to review several documents that can help you understand the scope, criteria, and objectives of the audit, as well as the roles and responsibilities of the auditors and the auditees. Here are some of the documents that you should review before conducting or participating in a quality audit.

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Prakash Jha

Sr Engineer in QA/QC @INOXCVA | Ex HLE Glascoat Limited |Six Sigma Black Belt | EX-L&T Defence |
Eva González Colomina

Reviso procesos para departamentos o negocios | Tecnología e innovación para gestionar el laboratorio | Mapa de…

1 Audit plan

The audit plan is a document that outlines the purpose, scope, schedule, and resources of the audit. It also defines the audit criteria, which are the standards, policies, procedures, and guidelines that the audit will use to evaluate the performance and compliance of the project, process, or product. The audit plan should be approved by the audit sponsor and communicated to the audit team and the auditees in advance. Reviewing the audit plan can help you prepare for the audit by clarifying the expectations, objectives, and methods of the audit.

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Eva González Colomina

Reviso procesos para departamentos o negocios | Tecnología e innovación para gestionar el laboratorio | Mapa de procesos | Instrumentos, consumibles y servicios de soporte ?? Cromatografía | Espectroscopia | Formación
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Los planes de aditoría varian según el estándard iso auditado. También varían en función de si se trata de una auditoría externa o interna. En cualquier caso el alcace debe estsr bien definido y ser aceptado por ambas partes. Debe incluir el informe de auditoría anterior para confirmar que las desviaciones detectadas se han corregido de forma que se propuso en su día.

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Saeed Saad Aziz, M.sc, PMP, PE

Quality Control Section Head @ Hassan Allam Construction | Mechanical
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Follow ISO 9001 for procedures and steps for documentation of quality audit of your project results. initiate project quality plan to define scope of work, reference codes and standards, and official forms and type of testing.

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Sílvia Santos

Head of Unit || Passionate about Quality
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From the auditee's perspective, reviewing documents only on the eve of the audit does not usually produce good results. Documents must be updated regularly, whenever necessary (for example whenever there are changes in the internal and/or external context), and not just to show auditors.

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2 Audit checklist

The audit checklist is a tool that helps the auditors to organize and conduct the audit in a consistent and efficient manner. It contains a list of questions or items that the auditors will use to verify the compliance and effectiveness of the project, process, or product against the audit criteria. The audit checklist should be based on the audit plan and tailored to the specific context and scope of the audit. Reviewing the audit checklist can help you familiarize yourself with the areas and aspects that the audit will cover and the evidence that the auditors will look for.

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Eva González Colomina

Reviso procesos para departamentos o negocios | Tecnología e innovación para gestionar el laboratorio | Mapa de procesos | Instrumentos, consumibles y servicios de soporte ?? Cromatografía | Espectroscopia | Formación
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Lo que más ayuda al auditor a preparar una auditoría es el organigrama de la organización, lista de procedimientos de trabajo y el mapa de procesos.

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Saeed Saad Aziz, M.sc, PMP, PE

Quality Control Section Head @ Hassan Allam Construction | Mechanical
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Process flow, checklist and cheat sheet are used as quality control tools to verify the compliance between the results and the standards and specs.

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3 Audit report

The audit report is a document that summarizes the findings, conclusions, and recommendations of the audit. It also includes any nonconformities, which are deviations or violations from the audit criteria, and any opportunities for improvement, which are suggestions or best practices that can enhance the performance and compliance of the project, process, or product. The audit report should be objective, factual, and clear, and follow the agreed format and structure. Reviewing the audit report can help you understand the results and implications of the audit, as well as the actions that need to be taken to address the issues and gaps identified by the audit.

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Saeed Saad Aziz, M.sc, PMP, PE

Quality Control Section Head @ Hassan Allam Construction | Mechanical
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All results and progress should be recorded in reports or presentation, included variation, change orders, percentage of completion,. hot issues, technical analysis

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4 Audit records

The audit records are the documents and data that support and document the audit process and outcomes. They include the audit plan, the audit checklist, the audit report, and any other evidence, such as notes, observations, interviews, samples, photographs, or test results, that the auditors collected during the audit. The audit records should be accurate, complete, and reliable, and stored in a secure and accessible location. Reviewing the audit records can help you verify and validate the audit findings and conclusions, as well as provide feedback and input for future audits.

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5 Quality management system

The quality management system (QMS) is a set of policies, procedures, processes, and tools that the organization uses to plan, implement, monitor, and improve the quality of its products, services, and operations. The QMS should be aligned with the customer requirements, the organizational goals, and the industry standards, and should follow the principles and practices of quality management, such as customer focus, leadership, involvement of people, process approach, continual improvement, factual decision making, and mutually beneficial relationships. Reviewing the QMS can help you understand the context and culture of the organization, as well as the roles and responsibilities of the people involved in the quality activities.

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Nathan Kluger, BSEE MBA

Defense, Aerospace, and Medical Systems Engineer
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The QMS is a good overall indicator of the level of quality integration in a companies hierarchy. When available for review before the audit, look for the following signs in a QMS - 1) Recent changes that show it’s an actively used set of guidelines. 2) Wording and structure specific to the company/ industry shows it’s not a QMS that was copied and pasted but rather adapted and unique to the specific application. 3) Order that’s easy to follow and links to specific documents you’d like to review during the audit. 4) Gaps or missing sections that are required by regulation or certifying body. 5) A quality index that outlines the entire QMS and reduces search time during the audit itself. A QMS is a an indicator of overall health.

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Nathan Kluger, BSEE MBA

Defense, Aerospace, and Medical Systems Engineer
(已编辑)
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The QMS is a good overall indicator of the level of quality integration in a companies hierarchy. When available for review before the audit, look for the following signs in a QMS 1) Recent changes that show it’s an actively used set of guidelines. 2) Wording and structure specific to the company/ industry shows it’s not a QMS that was copied and pasted but rather adapted and unique to the specific application. 3) Order that’s easy to follow and links to specific documents you’d like to review during the audit. 4) Gaps or missing sections that are required by regulation or certifying body. 5) A quality index that outlines the entire QMS and reduces search time during the audit itself. A QMS is an indicator of overall health.

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6 Customer feedback

Customer feedback is the information and opinions that the customers provide about the quality and satisfaction of the products, services, and interactions that they receive from the organization. Customer feedback can be collected through various methods, such as surveys, reviews, ratings, testimonials, complaints, or suggestions. Customer feedback can help the organization to measure and improve its performance, identify and meet the customer needs and expectations, and build and maintain customer loyalty and trust. Reviewing customer feedback can help you evaluate the impact and value of the project, process, or product from the customer perspective, as well as identify any gaps or issues that need to be addressed or resolved.

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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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Prakash Jha

Sr Engineer in QA/QC @INOXCVA | Ex HLE Glascoat Limited |Six Sigma Black Belt | EX-L&T Defence |
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Conducting a successful quality audit involves thorough preparation and a comprehensive review of various documents. However, here is a general list of documents that are commonly reviewed during a quality audit: 1-Quality Manual 2-Quality Policy 3-Procedures and Work Instructions 4-Quality Objectives and Targets 5-Records of Training and Competence 6-Document Control Records 7-Internal Audit Reports 8-Non-Conformance Reports (NCRs) 9-Corrective and Preventive Action (CAPA) Records 10-Customer Complaints and Feedback 11-Supplier Quality Records 12-Calibration and Maintenance Records 13-Risk Management Documents 14-Management Review Meeting Minutes 15-Regulatory Compliance Documents 16-Process Performance Data 17-Change Control Records

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Suhas Deshpande

?? Elevate Efficiency, ?? Enhance Effectiveness & ?? Drive Cost Optimization with our proven methods and solutions! #FutureOfWork#BusinessExcellence
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It depends on what type of audit it is. If it's a QMS certification or surveillance audit the depth and coverage of the audit are different. For a full system certification or recertification, all business processes will be audited so you will have to ensure records generated in all these processes are easily accessible and legible. Whereas for a surveillance audit, the scope will be limited to a few processes each year during the cycle. So you need to focus on those areas. Similarly, a customer audit may look at the whole QMS OR depending on their area of interest focus on areas like design and manufacturing.

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What documents should you review to ensure a successful quality audit?

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3

4

5

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7

1 Audit plan

2 Audit checklist

3 Audit report

4 Audit records

5 Quality management system

6 Customer feedback

7 Here’s what else to consider

Quality Management

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What documents should you review to ensure a successful quality audit?

1

2

3

4

5

6

7

1 Audit plan

2 Audit checklist

3 Audit report

4 Audit records

5 Quality management system

6 Customer feedback

7 Here’s what else to consider

Quality Management

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