VALIDATION
To ensure that manufactured product meets specifications and has uniform quality to meet external requirements.
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QP 3.3
1) RESPONSIBLIITY:
Chief Quality Officer
Daniela Kozar
Responsibilities
responsible for the creation, completion, and saving of validation plans, protocols, and reports, and ensures all required validation is completed.
Facilities/Maintenance Supervisor:
Harry Evans (PSP East)
Joe Soria (PSP West)
Responsibilities:
responsible for receiving all manufacturing equipment installation paperwork and providing them to the Quality Department
2) RELATED REQUIREMENTS:
ISO 13485
7.5.6 Validation of processes for production and service provision
AS9100
8.5.1.2 Validation and Control of Special Processes
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
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, or justification will be noted on the monthly quality meeting.
Sustainability (Resource needs regarding training, equipment, software, man power): Y
I
5) ACTIVITIES AND EXPECTATIONS:
ACTIVITES:
EXPECTATIONS:
6) PROCESS INPUTS:
Source of Input:
7) PROCESS OUTPUTS:
Source of Output:
8) RELATED DOCUMENTS:
Policies:
Procedures:
SOP-3.3-001 Validation
Documents:
Work Instructions:
Validation Records
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
10) INTERNAL AUDIT- VALIDATION AND VERIFICATION:
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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