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QP 4.4.1-001 Rev A; effective ______
1) TEAM:
Quality Process Administrator:
Quality Process Team Member:
2) RELATED REQUIREMENTS:
Personnel 6.2
Supplier 4.1.5, 7.4.1
Purchase Product 7.4.3
Software Validation 4.16, 7.5.6, 7.6
ISO 13485 Reference
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
The term risk, within the context of ISO 13485 compliant Quality System, applies primarily to the safety and performance of the medical device. It also includes compliance to applicable regulatory requirements on a secondary basis. Business risks, while important for setting priorities and objectives, are not included in the scope of ISO 13485.
Risk will cover the following items:
Safety-related issues
Product performance
Regulatory compliance
4) EFFECTIVENESS MEASURE:
Measurable quality objectives are established within the monthly quality meeting report, section quality objectives.
Quality objectives are verified for effectiveness on a monthly basis.
If the quality objectives are not met, management will assign activities to ensure that the quality process will perform within set guidelines
The effectiveness of the Risk Management Process is measured as part of the
HR Process (risk associated with the work for which the training or other action is being provided)
Purchasing Process (The organization shall establish criteria for the evaluation and selection of suppliers. The criteria shall be: d) proportionate to the risk associated with the medical device.)
Customer Satisfaction (Risk associated with product performance including software validation and process validation)
5) PROCESS INPUT:
All applicable customer, legal and quality requirements
Process risk and opportunity
Product related risk
Risk management form (pFMEA)
6) ACTIVITIES AND EXPECTATIONS:
EXPECTATIONS:
RISK ASSESSMENT
RISK MITIGATION
COMMUNICATION OF RISK MITIGATION ACTIVITIES AND REQUIREMENTS
a) Completion of the LS 4.4-003 pFMEA (Risk and Opportunity Matrix) for all quality processes
b) Re-initiation of the risk management process for new or revised product and/or processes
d) Communication of risk mitigation activities to all applicable personnel and documents
e) Completion of LS 4.4-003 pFMEA (Risk and Opportunity Matrix) for every applicable risk management activity
g) Re-validation of the risk management process on yearly basis and, if applicable as part of the Corrective Action Process.
h) Communication of "GENERAL" risk mitigation activities through:
Internally; specific training materials
externally, Supplier Product/Process assurance requirements (SPAR)
i) Communication of "Process, or Product-specific" risk mitigating activities through:
Internally: Job Traveler and other written instructions including visual aids
externally: Through specific purchase order notes or other written instructions including technical drawings
7) PROCESS OUTPUT:
Accepted or rejected risk
Completed LS 4.4-003 pFMEA (Risk and Opportunity Matrix)
Acceptance record on customer drawing (if applicable)
Communicated risk mitigation methods (within, job traveler, purchasing requirements, training material)
8) RELATED DOCUMENTS:
9) TRAINING REQUIREMENTS:
10) VERIFICATION AND VALIDATION:
nternal audit performed on: March 2021
Auditor: Peter Pichler, Nick Martinez
Audit Notes:
The following elements will be validated and/or verified as part of the scheduled internal auditing process.
Validation:
Quality system validated as part of the internal audit
Verification:
Compliance with all applicable requirements
Corrective actions against this process have been closed and are effective
Training Effectiveness
Status of documented information (have there been any changes or new documents issued and if documents have been changed or added have all applicable employees trained)
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