Identifying context for every process in an organization

[Coury Ferguson]

As the Client of the audit it boils down to this; when the auditor or his organization seems to be making up the rules you must ask:

1) Show me within the standard were it is required
2) Show me within the ISO/TC 176 Approved Interpretations Against ISO 9001:2015 were it is required
3) Show me within the ISO/IAF ISO 9001 Auditing Practices Group documents were it is required.

[FONT=&quot]If the auditor insists you simply thank him/her and ask who within his/her organization to address the audit finding appeal in accordance with ISO 17021-1 CB requirements. Draft your formal appeal and send it [FONT=&quot]in[/FONT]. If they do not address your appeal, or appear to be incorrect, you then should go to ANAB and ask for a clarification.[/FONT]

Valid points. Thanks.

 

[LUV-d-4UM]

You appear to have a negative attitude toward CB Auditors. May I ask you a question that really doesn't have any thing to do with this thread. Are you a Consultant by chance?

As for the CB Auditor's interpretation, at times there are CB Auditors that may interpret something differently. Their job is to review, analyze, document results and any findings. It is up to the organization to challenge this during the closing meeting, show your facts, and they show you their facts. Come to a resolution with documented results. If no resolution is agreed upon then your responsibility is to elevate to the CB itself. Then they will determine who has the correct facts.

Just my take on this.

I hope this is not a negative reflection on a CB auditor. They are just learning the standard like ourselves. We just need to have a a healthy conversation of what really is the intent of the standard. It's OK to disagree. There are moderators who can serve as referee. And the CB auditors should also be open to questions.

 

[Coury Ferguson]

I hope this is not a negative reflection on a CB auditor. They are just learning the standard like ourselves. We just need to have a a healthy conversation of what really is the intent of the standard. It's OK to disagree. There are moderators who can serve as referee. And the CB auditors should also be open to questions.

I am in agreement with you. I use to be a 3rd Party CB Auditor.

 

[LUV-d-4UM]

Nobody is perfect. I can understand that auditors do not want to be challenged. But we can have a healthy conversation. And in the end during the closing, auditors must articulate what is the SHALL requirement that is violated. If he cannot do that, they the finding is not real.

 

[BoardGuy]

[FONT=&quot]I do rather enjoy the use of the IAF/ISO Audit Practices Group documents during CB audits. In their 13 January 2016 Guidance on Nonconformity Documenting it is clearly stated “if there is no audit evidence – there is no nonconformity”. I’ve seen some auditors write up findings that start with there is no evidence… [/FONT]

 

[LUV-d-4UM]

Auditors have to write the evidence of the nonconformity and the nonconformity must be registered against a requirement of the standard and the company's own policy or procedure.

 

[JoShmo]

[FONT=&quot]I do rather enjoy the used of the IAF/ISO Audit Practices Group documents during CB audits. In their 13 January 2016 Guidance on Nonconformity Documenting it is clearly stated “if there is no audit evidence – there is no nonconformity”. I’ve seen some auditors write up findings that start with there is no evidence… [/FONT]

Of course! If the organization hasn't implemented part of its management system, let's say preventive maintenance, so there's no records, no plan etc, despite there being procedureal documents to suggest it's being done, how else does an nc get written?

 

[JoShmo]

You appear to have a negative attitude toward CB Auditors. May I ask you a question that really doesn't have any thing to do with this thread. Are you a Consultant by chance?

Off topic perhaps, but:
Why would that be the case? What about all those register auditors who are also consultants? You don't have to spend long on such forums to know that there's plenty of negativity towards CB auditors from other than consultants - they try to protect clients from wacky "interpretations" - which isn't the registers auditors job anyways. As for auditors "learning", what's to learn? This stuff isn't, never has been rocket science! Anyone who knows this quality stuff from before the hype and got more than a certificate from a lead auditor course should know 2015 isn't such a big deal. Of course, if you never made a mental change from 1994 requirements, your gonna be SOL...

 

[Sidney Vianna]

[FONT=&quot]I do rather enjoy the used of the IAF/ISO Audit Practices Group documents during CB audits. In their 13 January 2016 Guidance on Nonconformity Documenting it is clearly stated “if there is no audit evidence – there is no nonconformity”. I’ve seen some auditors write up findings that start with there is no evidence… [/FONT]

As with many others, that particular ISO Paper is poorly written.

In the last paragraph of the first page we read:

If there is no audit evidence – there is no nonconformity. If there is evidence – it must be documented as a nonconformity, instead of being softened with another classification

It should have been clearer. What they meant to say was:

If there is no audit evidence OF A FAILURE TO SATISFY A REQUIREMENT – there is no nonconformity. If there is evidence – it must be documented as a nonconformity, instead of being softened with another classification

Audit evidence can show conformity or nonconformity to requirements. In your example, when you mention that some auditors state a nonconformity by using the words of "....there is no evidence of....", the next few words in that sentence should state the identified requirement not being complied with.

For example, imagine an organization which self imposed a requirement that any (potential and/or confirmed) nonconforming material and/or product should be promptly segregated in a locked crib. If the auditor sees nonconforming product on open shelves, s/he could write a nonconformity statement stating that (for example) there is no evidence that nonconforming product is being promptly segregated in locked cribs, as required in procedure NCMR 013, Rev.C, Paragrah 4.8; evidence shows multiple products such as widgets P/N 65540-09 and P/N 6368-003 identified with nonconforming tags, but left in open shelves by workstation A3....

 

[Jen Kirley]

It seems worthwhile to consider the processes when determining context of the organization, since interested parties may vary among the processes, and internal/external issues may vary from process to process.

But I have been finding myself cautioning "Don't overthink this thing" and this CB auditor could be asking for, or be misunderstood to be asking for, a much more detailed approach than is needed. Not having been present, I can't tell which...

It is true that CB auditors are getting used to the revised standard at the same time as users are. For that reason I have found the ISO TC/176/SC2 (Technical Committee) web page to be very useful, having many links to papers on these various subjects and especially links for auditing. In this specific case, there's a guidance paper on Context. I would not let a nonconformity stand without dispute if it does not align with these papers. They are not the standard, but they originate from the group that promulgated the standard and so they are sorely needed right now - even though, I agree with Sidney, some could be written better.

I hope this helps!