Undocumented Desk Procedures not incorporated into our QMS

[wooden nickle]

Recently during our AS9100B audit, the auditor discovered that we had a couple of "Desk Procedures" not incorporated into our QMS. They were not one of the required six documented procedures. One is a guideline for transferring work to a subcontractor and the other is a packaging matrix used by shipping to record the materials used to pack goods to be sent to a customer. Our Auditor issued an AR for having undocumented procedures. My only argument was that a documented procedure for these issues was not required by the standard. Who is correct?

 

[Jason PCSwitches]

Re: Undocumented Desk Procedures

Documented procedures may not be required. Were you able to demonstrate process conformity? When you state "matrix" is that a document? If so is it controlled?

Going by your statement, no, a "documented" procedure is not required & if the process is functioning effectively their is no need for one. However, if the auditor found discrepancies within the process, that should be the N/C, not the fact that a "documented" procedure didn't exist.

Give some more specifics so we can be sure of what was intended. IF you can, provide the exact N/C statement as written by the auditor and site the clause it was written against.

 

[wooden nickle]

Re: Undocumented Desk Procedures

This is an exact lift from the report:
Reqmt: The documented requuirements shall include the controls for approval and control of changes to documention.
Finding: Not all documents are controlled.
Objective evidence:
1. Subcontract procedures and associated outsource requirements form are uncontrolled documents.


Again my argument is that a QMS documented procedure for this requirement is not required.

 

[Jason PCSwitches]

Re: Undocumented Desk Procedures

Yeah, this doesn't make much sense. I agree that change control and approval should be defined in your document control procedure, but the rest is not very clear. Is there anything else they sited as evidence besides the absence of a documented procedure? They had to base the finding on evidence, again besides the absence of the documented procedure(s) what else did they observe if anything?

Can anyone else help shed some light on this one??

 

[Stijloor]

Re: Undocumented Desk Procedures

This is an exact lift from the report:
Reqmt: The documented requuirements shall include the controls for approval and control of changes to documention.
Finding: Not all documents are controlled.
Objective evidence:
1. Subcontract procedures and associated outsource requirements form are uncontrolled documents.


Again my argument is that a QMS documented procedure for this requirement is not required.

If you decide to write a procedure for an activity in your QMS (even though the Standard may not require a written procedure for that process) then it must still be controlled.

Stijloor.

 

[Jason PCSwitches]

Re: Undocumented Desk Procedures

Now, if the matrix you talk about and any additional documents are not in you control system that is a different story. After reading the N/C again I'm not so sure they hit you for not having a documented procedure, they hit you for not having the existing associated documents in your document control system.

 

[howste]

Re: Undocumented Desk Procedures

If you decide to write a procedure for an activity in your QMS (even though the Standard may not require a written procedure for that process) then it must still be controlled.

Stijloor.

Jan is right. Based on the description of the nonconformity, it's not saying you don't have procedures, it's saying that the procedures you already have are uncontrolled.

Here are the relevant requirements in AS9100:

4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include...
d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

4.2.3 Control of documents
Documents required by the quality management system shall be controlled.

 

[wooden nickle]

Re: Undocumented Desk Procedures

Thanks, for your information, I really appreciate the input. The associated documents would be records that product was shipped to X and was returned from X. These records are of little consequence once the material has been returned.