INTERNAL AUDIT
To assess the effectiveness of the QMS and ensure it conforms to the planned and documented arrangements, applicable regulatory and standard requirements, and the QMS requirements
To assess the effectiveness of the QMS and ensure it conforms to the planned and documented arrangements, applicable regulatory and standard requirements, and the QMS requirements
QP 5.2
1) RESPONSIBLIITY:
Internal Auditor:
Daniela Kozar
Amanda Breen
Jasmine Seguritan
Itzael Colin
Roma Torcuato
Responsibilities:
Perform internal audits in accordance with ISO and AS standards, including the shop floor and office staff processes and procedures.
Work with the department managers when nonconformances are found during the internal audits to create a CAPA plan.
Work with the CQO and Quality Administrator to ensure CAPAs are closed out in a timely manner.
Monitor timely completion and updating of internal audit processes.
2) RELATED REQUIREMENTS:
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
Ensure the company's processes comply to standard and our own requirements
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
5) ACTIVITIES AND EXPECTATIONS:
ACTIVITES:
EXPECTATIONS:
6) PROCESS INPUTS:
Source of Input:
SOPs
Applicable standard clauses
7) PROCESS OUTPUTS:
Source of Output:
8) RELATED DOCUMENTS:
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)