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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?
2
How many incident reports were reviewed in the post-production phase?
Min: 0
Target: 0
Max: 100
3
Has post-market data been analyzed for safety issues?
4
What actions have been taken for continuous improvement based on post-production data?
5
When was the last quality audit conducted for this medical device?
6
Is the production process compliant with relevant regulatory standards?
7
How many non-conformance reports were generated during production?
Min: 0
Target: 0
Max: 50
8
What corrective actions have been implemented to address identified issues?
9
What is the status of feedback received from users regarding the product?
10
How many adverse event reports have been filed post-production?
Min: 0
Target: 0
Max: 100
11
Has a safety review been conducted based on the received feedback?
12
What follow-up actions are planned based on the feedback and reports?
13
When was the last performance review of the medical device conducted?
14
How many units have been returned due to malfunction complaints?
Min: 0
Target: 0
Max: 100
15
What is the overall user satisfaction level reported for the device?
16
What suggestions have been made for enhancing device performance?
17
Is all necessary compliance documentation up to date?
18
How many regulatory audits have been conducted in the last year?
Min: 0
Target: 0
Max: 10
19
Have all corrective actions from the last audit been implemented?
20
What feedback has been received from regulatory authorities regarding compliance?

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 of ISO 14971 Production and Post-Production Information Review Checklist

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