AS9100 Requirement Definition - Defined vs. Documented

Hello Professionals,
I am in need for some external help. I just completed the AS9100 Lead Auditor training with SAI Global and I was taught that a documented procedure is needed for whatever process is being audited within the AS9100 Standard. When I came back to work to apply what I have learned, other auditors who went through the training over 10 years ago stated the process does not have to be documented (on paper) but they have to tell you how they do their job verbally. I'm having an issue applying this concept because how do we as auditors know if the auditee is actually doing what management wants to meet the business objectives.

I'm having a problem with what to reference in the AS9100 with the absence of a process. Am I just over analyzing this. Please help. Point me in the right direction.

Thanks,
Cam

"I'm having a problem with what to reference in the AS9100 with the absence of a process. Am I just over analyzing this. Please help. Point me in the right direction."

Can you provide additional information as to where you are heading. Are you looking at developing a Quality Manual or are you looking at writing procedures or are you trying to demonstrate objective evidence how information is transfer from individuals to individuals in a consistent manner (Training, visual aid, charts, procedures...)

Cameron24 said:

<snip> I was taught that a documented procedure is needed for whatever process is being audited within the AS9100 Standard. <snip>

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The question is: "Show me the requirement". Many procedures are "trained" and have no documented procedure. Process operators in many scenarios do not need a documented procedure to do their job.

"...the process does not have to be documented (on paper) but they have to tell you how they do their job verbally..."

That has always been my understanding, but that's not to say AS9100 does not have required documented procedures for systems such as a documented non-conformance system. I am unaware of a requirement that each process have a specific documented procedure explaining exactly how to "do the job". On The Job training (OJT) comes into play here.

NOTE: I'm not an AS9100 person so I could be wrong - Waiting for one to reply.

On this topic, ISO 9001:2008 and AS9100C are the same.

4.2.1 c requires an organization to have documented procedures and records required by the standard.

4.2.1 d requires an organization to have documents, including records, determined by the organization to be necessary to ensure effective planning, operation, and control of its processes.

Speaking to 4.2.1 c, there are six topics specified in the standard that require documented procedures:
Control of documents
Control of records
Internal audit
Control of nonconforming material
Corrective actions
Preventive actions

The only options here are shown in Note 1 o 4.2.1 where it says that a single document may address one or more procedures or that a procedure may covered by more than one document.

So there are six mandatory topics, and an organization may add as many as they want/need.

I think your co-worker needs a refresher course.

On a related note, since the word defined came up in your post, is that the word defined is used in the later part of 4.1 where it talks about outsourcing. Here is says that the controls for outsourcing need to be defined in the quality management system. Defined does not necessarily mean documented.

The term "defined" is not part of the terminology in 4.2.1.

On re-reading the original post, I see there is even more misunderstanding.

There is no requirement to have a documented procedure for every task, not even every production related task, so you have a misunderstanding if you believe that. There is no requirement for work instructions for every task either. The closest the standard gets here is in 7.5.1 b where it requires work instructions to be available as necessary.

If the organization determines that work instructions are necessary, they are necessary and they need to be available. If they have not determined that work instructions are necessary, they are not necessary. If this is what you and your co-worker are squabbling about, your co-worker is correct.

This should be framed. Exactly right.

Six required documented procedures (I have 5, because I blended CA and PA), more as deemed required. Defined does not necessarily mean documented. Work instructions created as needed, no requirement to have a WI for everything.

Cameron24 said:

I just completed the AS9100 Lead Auditor training with SAI Global and I was taught that a documented procedure is needed for whatever process is being audited within the AS9100 Standard.

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Are certain of this? If you are, and they really taught you that, this is very unfortunate and not what I would expect from QM-SAI Global. It is not correct.

There are six procedures that require documentation as per AS9100C, and you create more as the organization deems necessary. For work instructions, you also create them as deemed necessary. If it's decided that WI are needed, they need to be controlled, approved and made available where they are to be used. Outside the six required procedures, verbal is fine as long as you can show that the process is controlled, i.e. the staff are all on the same page. if they aren't, that's your first indication that a WI may be necessary.

Hope that helps.

I recently completed the Certified Lead Auditor training with BSI and was taught that documentation is only required for procedures where the standard specifically calls for a documented procedure. So I agree with the other posters that only six procedures need to be documented and they can be documented in whatever form is best for the company (one doc, multiple docs, etc).

Furthermore, I was also taught that "documented" could mean that everyone involved in the process knows the exact same procedure - that it need not be something I can read. I'd be interested in what others have seen in that regard.

You are referring to the AS9100 Lead Auditor course, correct?

SmallBizDave said:

I recently completed the Certified Lead Auditor training with BSI and was taught that documentation is only required for procedures where the standard specifically calls for a documented procedure. So I agree with the other posters that only six procedures need to be documented and they can be documented in whatever form is best for the company (one doc, multiple docs, etc).

Furthermore, I was also taught that "documented" could mean that everyone involved in the process knows the exact same procedure - that it need not be something I can read. I'd be interested in what others have seen in that regard.

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SmallBizDave,

Not quite.

The definition of procedure makes it clear that a procedure may be documented or not. A documented procedure is documented to the extent necessary for effective planning, operation and control.

And 4.2.1d makes it clear that the organization may decide that it needs to document more procedures than the famous six mentioned in 4.2.1c.

John

Cameron24 said:

Hello Professionals,
I am in need for some external help. I just completed the AS9100 Lead Auditor training with SAI Global and I was taught that a documented procedure is needed for whatever process is being audited within the AS9100 Standard. SNIP Please help. Point me in the right direction.

Thanks,
Cam

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You have been taught wrong, apparently. Refund?

First, I would encourage you to read what the IAQG disseminates via their AS9100C Auditor Guidance Document. Pay close attention to the guidance to section 4.2.1 of AS9100C:

Documentation requirements
4.2.1 General
What to look for
Consideration by the organization of:
• availability of relevant Quality Management System documentation and changes (not only procedures) at all places to be asked all through the audit
• existence of a list of documents, including the documented procedures required by the QMS standard and by the organization itself
• availability of documents in the different work places / shop floors by asking various people
• issue of the documents and regular updates
• samples upwards and downwards showing that the references to and from the procedures are correct (if the documented procedures are not part of the QM)
NOTES:
The list itself is NOT a requirement
The international standard requires, at least, the following documented procedures:
- 4.2.3 Control of documents
- 4.2.4 Control of records
- 8.2.2 Internal audits
- 8.3 Control of nonconforming product
- 8.5.2 Corrective actions
- 8.5.3 Preventive actions

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As for auditing process in the absence of, or minimal documentation, you can always refer to the ISO TC paper titled Auditing a QMS which has minimum documentation.

Good luck.