Procedure for Control of Non Conformity MDA

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Procedure for Control of Non-Conforming Output

ISO 9001:2015 for a Ministry, Department, or Agency (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

5.1 Identification and Documentation

1. When a non-conforming output is detected, it shall be identified by attaching a "Non-


Conformance" tag or equivalent mark.
2. The non-conformance shall be documented in the Non-Conformance Report (NCR) form.
3. Details to be recorded include:
o Description of the non-conformance
o Date and time of detection
o Responsible personnel
o Reference number (e.g., report number, service request ID)
o Quantity or extent affected

5.2 Segregation

1. Non-conforming outputs shall be segregated from conforming outputs to prevent unintended


use.
2. Designated areas or systems for non-conforming outputs shall be clearly marked.

5.3 Evaluation and Disposition

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.

5.5 Corrective Actions

1. If the non-conformance indicates a systemic issue, a corrective action shall be initiated.


2. The root cause of the non-conformance shall be identified and documented.
3. Corrective actions shall be implemented to prevent recurrence and documented in the
Corrective Action Report (CAR) form.

5.6 Communication

1. Relevant personnel shall be informed of non-conformances and the actions taken.


2. Regular meetings shall be held to review non-conformances and corrective actions.

5.7 Review and Closure

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

 Non-Conformance Report (NCR) forms


 Corrective Action Report (CAR) forms
 Rework records
 Inspection records

7. References

 ISO 9001:2015 Standard


 [MDA Name] Quality Manual

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