CONTROL OF DOCUMENTS AND RECORDS
Ensuring the availability and accuracy of all quality management system documents and records
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QP 4.3
1) RESPONSIBILITY:
Document Control Specialist:
Amanda Breen
Responsibilities:
Manage the QMS documents and records including maintaining accuracy and availability.
Ensure a closed loop change management process, including the review and implementation of new/changed documents and processes
Ensure employees are alerted/retrained to new revisions of QMS documents
Chief Quality Officer:
Daniela Kozar
Responsibilities:
Overall management of the QMS
Ensure all applicable standard/customer requirements are documented
Final review and approval of new and changed internal QMS documents
All employees are responsible for understanding the different types of documents at PSP, and who is approved to create and change internal and external documents.
Additional individual responsibilities are defined within the applicable job descriptions, Standard Operating Procedures, documents and work instructions.
2) RELATED REQUIREMENTS:
ISO 13485
4.1.4 General Change Requirements
4.2.1 General Document Requirements
4.2.2 Quality manual
4.2.3 Medical device file
4.2.4 Control of documents
4.2.5 Control of records
AS9100
7.5.1 General Document Requirements
7.5.2 Creating and Updating
7.5.3 Control of Documented Information
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVES:
To establish standards and procedures for document preparation, change, and version control
To ensure all employees are aware of applicable quality documents and where/how to locate them
4) EFFECTIVENESS MEASURE:
Measurable KPI's are established within the monthly quality meeting report, section Key Performance Indicators.
KPI's are verified for effectiveness on a monthly basis.
If the KPI's are not met, management will assign activities to ensure that the quality process will perform within set guidelines.
EFFECTIVENESS MEASURES (KPI's):
NOTE:
The team will start with an estimate for the goal each month as a base line, and will adjust as we see fit throughout the year
A comment shall be added to the goal each time it is adjusted
5) ACTIVITIES AND EXPECTATIONS:
ACTIVITIES:
EXPECTATIONS:
6) PROCESS INPUTS
Source of Input
Quality Documents
Statutory and Regulatory Requirements
Customer Requirements
7) PROCESS OUTPUTS:
Source of Output:
Quality Records
Quality Documents
8) RELATED DOCUMENTS:
Policies:
Procedures:
Documents:
Work Instructions:
Reference Docs:
9) TRAINING REQUIREMENTS:
Training plans have been created for the positions listed in the responsibilities section
Click on the appropriate link below to see the training plan for that position
The supervisor is responsible for ensuring their employees are completing their training plans within the specified time requirements
Document Control Specialist Training Plan
10) INTERNAL AUDIT- VALIDATION AND VERIFICATION:
Internal audit performed on: _______
Auditor: _________
Findings: _______
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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