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ISO 14971 Production and Post-Production Information Review Checklist

A comprehensive checklist designed to guide medical device manufacturers in systematically reviewing and analyzing production and post-production information to maintain effective risk management throughout the product lifecycle, in compliance with ISO 14971 standards.

ISO 14971 Production and Post-Production Information Review Checklist

by: audit-now
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About This Checklist

The ISO 14971 Production and Post-Production Information Review Checklist is a crucial tool for medical device manufacturers to ensure ongoing risk management throughout the product lifecycle. This checklist guides organizations in systematically collecting, analyzing, and acting upon information gathered during production and post-production phases. By implementing this checklist, companies can effectively identify new or changed risks, evaluate the impact on existing risk assessments, and initiate appropriate actions to maintain product safety and performance. This proactive approach aligns with ISO 14971 requirements for continuous risk management and supports regulatory compliance while enhancing patient safety.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Quality Assurance Specialist
Post-Market Surveillance Manager
Regulatory Affairs Coordinator
Product Safety Engineer
Clinical Data Analyst
1
Is the risk management process compliant with ISO 14971 standards?

Select the compliance status.

To ensure that risk management practices are in accordance with regulatory requirements.
2
How many incident reports were reviewed in the post-production phase?

Enter the number of incident reports reviewed.

To assess the thoroughness of post-market surveillance.
Min: 0
Target: 0
Max: 100
3
Has post-market data been analyzed for safety issues?

Indicate whether post-market data analysis has been performed.

To confirm that data analysis is being conducted for continuous improvement.
4
What actions have been taken for continuous improvement based on post-production data?

Provide details of continuous improvement actions.

To document actions taken to enhance product safety and effectiveness.
5
When was the last quality audit conducted for this medical device?

Select the date of the last quality audit.

To track the frequency of quality audits and ensure timely reviews.
6
Is the production process compliant with relevant regulatory standards?

Select the compliance status.

To ensure that production processes meet regulatory requirements.
7
How many non-conformance reports were generated during production?

Enter the number of non-conformance reports.

To evaluate the effectiveness of the quality management system.
Min: 0
Target: 0
Max: 50
8
What corrective actions have been implemented to address identified issues?

Detail the corrective actions taken.

To document responses to issues and ensure accountability.
9
What is the status of feedback received from users regarding the product?

Select the feedback status.

To assess how user feedback is being managed and acted upon.
10
How many adverse event reports have been filed post-production?

Enter the number of adverse event reports.

To monitor safety issues related to the product after it has been released.
Min: 0
Target: 0
Max: 100
11
Has a safety review been conducted based on the received feedback?

Indicate whether a safety review has been completed.

To ensure that safety considerations are prioritized in the post-market phase.
12
What follow-up actions are planned based on the feedback and reports?

Provide details of planned follow-up actions.

To outline future actions for improvement and ensure accountability.
13
When was the last performance review of the medical device conducted?

Select the date of the last performance review.

To ensure that performance evaluations are performed regularly.
14
How many units have been returned due to malfunction complaints?

Enter the number of units returned for malfunction.

To assess the reliability of the medical device in the market.
Min: 0
Target: 0
Max: 100
15
What is the overall user satisfaction level reported for the device?

Select the user satisfaction level.

To gauge user perception and identify areas for improvement.
16
What suggestions have been made for enhancing device performance?

Detail any suggestions for performance enhancements.

To collect input for potential improvements and innovations.
17
Is all necessary compliance documentation up to date?

Select the compliance documentation status.

To ensure that all regulatory documents are current and available for review.
18
How many regulatory audits have been conducted in the last year?

Enter the number of regulatory audits conducted.

To track the frequency of regulatory audits and ensure compliance.
Min: 0
Target: 0
Max: 10
19
Have all corrective actions from the last audit been implemented?

Indicate whether corrective actions have been implemented.

To confirm that necessary actions have been taken to address audit findings.
20
What feedback has been received from regulatory authorities regarding compliance?

Provide details of feedback received.

To document any insights or recommendations provided by regulatory bodies.

FAQs

The primary focus is on systematically reviewing and analyzing information gathered during production and post-production phases to identify new risks, evaluate existing risk assessments, and initiate necessary actions to maintain product safety and effectiveness.

The checklist covers sources such as production data, customer feedback, complaint records, adverse event reports, post-market surveillance data, scientific literature, and regulatory updates.

Reviews should be conducted on an ongoing basis, with formal assessments typically performed quarterly or semi-annually, and immediate reviews triggered by significant events or new information.

By ensuring regular review of real-world data, the checklist helps validate initial risk assessments, identify new hazards, and drive continuous improvement in risk control measures throughout the product lifecycle.

The process should involve a cross-functional team including quality assurance, regulatory affairs, product management, engineering, and clinical affairs representatives to ensure comprehensive analysis and appropriate action.

Benefits

Ensures continuous risk management beyond the design phase

Facilitates early detection of emerging risks or safety issues

Supports compliance with ISO 14971 and regulatory requirements

Improves product quality and safety through data-driven insights

Enhances manufacturer responsiveness to real-world product performance