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Guide to
Quality Defect Investigation ReportsSURG00201
03 JUNE 2009
This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. HERA Guide to Quality
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How to fill out quality defect investigation reports

How to fill out quality defect investigation reports
01
Start by gathering all the necessary information about the quality defect.
02
Identify the specific details of the defect, such as the nature of the problem, location, date, and any other relevant information.
03
Document the impact of the defect on the product or process, including any potential risks or hazards.
04
Record the root cause of the defect by conducting a thorough investigation and analysis.
05
Outline the corrective actions that need to be taken to resolve the defect and prevent its recurrence.
06
Include any supporting evidence or documentation, such as photographs, test results, or witness statements.
07
Provide a clear and concise summary of the defect investigation findings.
08
Obtain necessary approvals and sign-offs for the report before distributing it to relevant stakeholders.
09
Review and update the report as needed, especially if new information or developments arise.
Who needs quality defect investigation reports?
01
Quality control managers who are responsible for ensuring product quality and identifying and resolving defects.
02
Manufacturing companies that aim to improve their product quality and prevent defects in their processes.
03
Regulatory bodies that require documentation of quality defect investigations for compliance purposes.
04
Product development teams that need to understand and address quality issues during the design and manufacturing stages.
05
Supplier assessment teams that evaluate the quality performance of suppliers and require defect investigation reports as part of their evaluation process.
06
Auditors or external reviewers who assess the effectiveness of the defect investigation process and the actions taken to prevent recurrence.
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What is quality defect investigation reports?
Quality defect investigation reports are detailed documents that outline issues with the quality of a product or service and investigate the root cause of the defects.
Who is required to file quality defect investigation reports?
Typically, manufacturers, suppliers, or distributors are required to file quality defect investigation reports.
How to fill out quality defect investigation reports?
Quality defect investigation reports should be filled out thoroughly and accurately, including details about the defect, its effects, and any corrective actions taken.
What is the purpose of quality defect investigation reports?
The purpose of quality defect investigation reports is to identify and address quality issues in products or services to ensure customer satisfaction and safety.
What information must be reported on quality defect investigation reports?
Information on quality defect investigation reports should include details about the defect, its impact, root cause analysis, corrective actions taken, and preventive measures implemented.
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