Defect codes and process codes need to be controlled



We have a Boeing contract for Air Force product. We recently had a Air Force audit and the QAS generated a finding stating, "NCR defect codes and process codes are not controlled." He advised us because we manufacturer/assemble critical safety items and have serialization requirements, the codes must be controlled, at a minimum, "start date, reason code was generated, control changes to the code(s), end-of-life for the codes to include reason." During the audit, we provided him a procedure with the codes listed. When he asked specifics of when the code(s) were implemented, we could not provide him this information and this included end-of-life (EOL) for the codes. He said this was necessary as we have elected to use the code as the means to address nonconforming product and therefore, these codes must be controlled.

I disagree as the codes are specific to the NCR incident report and we have the means to know what happen at that point in time and can trend for systemic issues. He disagrees and says we must have traceability back to the codes and the NCR report shall support the closed-loop process of planning a correction and evaluating its effectiveness. Because the codes are not controlled, the defect codes could be in error or not traceable to a previous incident. I am at my wits with this auditor about this finding!

He did say he is not looking for revision control of the codes, but a "type" of record of the defect and process code with the minimums I described above.

I reached out to our 3rd party certification body auditor and she stated she would have to investigate further, with a cost.

We are a AS9100D certified company and machine and assemble military and commercial components.

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Thank you for the information. What the Air Force auditor is looking for is when the codes were released, if any changes to the code definitions and EOL for the code. I think how this all came about, we had a defect code for bending. We decided we needed to clarify by adding two additional codes for bending errors based on human or machine. He stated because we basically took the one code and made two codes, there should have been a record of this change to include terminating the previous code on bending. He said when he trended our data, he saw the previous code gone and then two other codes in its place. This caused his data analysis reporting to be inaccurate as he does not have the ability trace back to a time and or a reason for the change with the code changes. He stated if we had a record, he could have incorporated the record into the audit report. Because of this, he wrote us up for not having controlled conditions for the defect and process codes. He stressed, defect codes are replacing the reason for the nonconformance. Defect codes and process codes does not relieve your organization from "the organization is expected to develop processes with the objective of ensuring that all discovered nonconformity(s) are identified, analyzed, managed, and controlled."

Controlled being one aspect for the defect codes and process codes.



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I think I get it.

-NCR Report from 2000: Code 01 means one thing on this report (operator error)
-NCR Report from 2019: Code 01 means something else on that report (calibration not conducted)

At one point in time, organization decided operator error was no longer a valid defect code. When? What would Code 01 mean in 2010, Calibration or Operator?

If you had a list of codes, with revisions, and a change history table describing 'Rev. 02 Code 01 changed from Operator to Calibration May 2, 2009', you would be able to determine the cause code meaning at the time of the report.

Is that the answer?


Kronos147, yes and no. Here is the air force finding, edited to remove some company details.

Procedure MMP10.2 Revision G only list defect and process codes used to identify the nonconformance and the process(es) of where the nonconformance occurred. Form MMP10.2FNCR has a field for 12. DEFECT CODE, and 18. PROCESS CODE as to identify "parameters" of the nonconformance. These codes define what actions to take and how to take them when nonconformity is discovered. The contractor was not able to provide records or other documentation for issuance of, changes and end of life for defect and process codes. Revision history of defect or process codes is not controlled causing previous nonconformance records not to be accurate.

AS9100D, 8.7.2 The organization shall retain documented information that: a. describes the nonconformity; 10.2.2 The organization shall maintain documented information that defines the nonconformity and corrective action management processes; Documented information required by the quality management system and by this International Standard shall be controlled to ensure.

Our first initial response to the corrective action, we do control the codes by revision history of the procedure. They rejected the response by saying they concur you maintain a list of active codes that may be used for a nonconformance, but this list does not contain a revision history of previous codes used in nonconformance responses. When you EOL a code, there still needs to be a record of that code to explain what it was at the time of the nonconformance. This we could not produce.

Our second corrective action to this finding is to generate a record with all the defect codes and their revision history. If we make any changes to the codes, we will note it on the record with date and a brief explanation of the change. The air force accepted this response.

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