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Procedure for Control of Non Conformity MDA
Procedure for Control of Non Conformity MDA
Procedure for Control of Non Conformity MDA
1. Purpose
To ensure that non-conforming outputs in the processes and services of the MDA are identified,
documented, and controlled to prevent unintended use or delivery.
2. Scope
This procedure applies to all services and processes provided by [MDA Name], including
administrative tasks, public services, and project deliverables.
3. Responsibilities
Quality Manager: Ensures compliance with this procedure and oversees the handling of non-
conforming outputs.
Department Heads: Identify and report non-conforming outputs within their departments.
Inspection Personnel: Inspect and segregate non-conforming outputs.
Document Control Officer: Maintains records of non-conforming outputs.
4. Definitions
Non-Conforming Output: Any service or process that does not meet specified requirements,
including incorrect reports, delayed services, and procedural errors.
Rework: Action taken to correct the non-conforming output.
Disposition: The decision made regarding the non-conforming output (e.g., rework, acceptance
under concession, cancellation).
5. Procedure
5.2 Segregation
1. The Quality Manager shall evaluate the non-conformance and determine the appropriate
disposition.
2. Possible dispositions include:
o Rework: Correct the error in the process or service.
o Accept under concession: Accept the non-conforming output if it meets the essential
requirements or can be utilized with minor deviations.
o Cancellation: Cancel the service or process if it cannot be corrected or accepted.
3. The disposition decision shall be recorded on the NCR form.
5.4 Rework
1. If rework is required, the responsible department head shall plan and execute the rework
process.
2. Reworked outputs shall be re-inspected to ensure they meet specified requirements.
3. Rework activities and results shall be documented in the NCR form.
5.6 Communication
1. The Quality Manager shall review all NCRs to ensure proper handling and closure.
2. NCRs shall be closed only after the non-conformance has been resolved and verified.
6. Records
7. References