What is the degree of evidence needed to report a nonconfomity?

Stijloor

Staff member
Super Moderator
#11
Re: Degree of evidence

From ISO 9000:2005:

3.8.1
objective evidence
data supporting the existence or verity of something
NOTE Objective evidence may be obtained through observation, measurement, test (3.8.3), or other means.
Jim and Stijloor...:D

Our posts should be sufficient and objective evidence of a clear definition.
 
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John Broomfield

Staff member
Super Moderator
#12
Re: Degree of evidence

What is the degree of evidence needed to report a nonconfomity? For example, outdated documents available at points of use. Should it be 3 samples of the same kind? or 1 sample of outdated document found will suffice?
Ka Pilo,

Why not ask the people responsible for monitoring their processes per 8.2.3?

You may then discover how permissive the work environment is per 6.4.

You may discover that the procedures and their work instructions specify unnecessary details.

The employees and their leaders should be the first to decide the criteria for success and when correction or corrective action is required per 4.1c and 8.2.3.

Replacing the care of employees and their leaders with auditors making this decision for them, I suggest, is counter to quality.

Quality cannot come from auditing alone.

John
 
K

Ka Pilo

#13
Re: Degree of evidence

Ka Pilo,

Why not ask the people responsible for monitoring their processes per 8.2.3?

You may then discover how permissive the work environment is per 6.4.

You may discover that the procedures and their work instructions specify unnecessary details.

The employees and their leaders should be the first to decide the criteria for success and when correction or corrective action is required per 4.1c and 8.2.3.

Replacing the care of employees and their leaders with auditors making this decision for them, I suggest, is counter to quality.

Quality cannot come from auditing alone.

John
I think the definition of "objective evidence" provided by Jim and Stijloor is equally applicable to both auditors and auditees. It's clear that the objective evidence may be obtained through observation, measurement, test, or other means though the amount of relevant evidence which a reasonable mind "might" accept as adequate to justify a conclusion is subjective.
 

Jim Wynne

Staff member
Admin
#14
Re: Degree of evidence

I think the definition of "objective evidence" provided by Jim and Stijloor is equally applicable to both auditors and auditees. It's clear that the objective evidence may be obtained through observation, measurement, test, or other means though the amount of relevant evidence which a reasonable mind "might" accept as adequate to justify a conclusion is subjective.
If an obsolete document has been observed at a point of use, there is no question, or there shouldn't be, whether a nonconformity exists. The existence of the document is the only objective evidence necessary to support the contention. However, if the contention is that the entire document control system has broken down, you'll need more evidence than a single out-of-place obsolete document to support it.

An example of evidence that shouldn't be considered objective is a verbal assertion by an operator that until 20 minutes ago, an obsolete document was being used. This is not something directly observed by the auditor, and as such shouldn't be used as the basis of a nonconformity finding. It might be cause for further investigation.

In internal audits there should be no question of subjectivity, because "major" and "minor" classifications aren't helpful. Either a nonconformity exists or it doesn't, and the need for and extent of corrective action should be left to management.
 

Marcelo

Inactive Registered Visitor
#15
Re: Degree of evidence

An example of evidence that shouldn't be considered objective is a verbal assertion by an operator that until 20 minutes ago, an obsolete document was being used. This is not something directly observed by the auditor, and as such shouldn't be used as the basis of a nonconformity finding. It might be cause for further investigation.
Being not directly observable does not mean that it's not traceable - verifiable. If you cannot observe something, but can verify the infromation (for example, in records), then you can use those as a basis for a NC.
 

Jim Wynne

Staff member
Admin
#16
Re: Degree of evidence

Being not directly observable does not mean that it's not traceable - verifiable. If you cannot observe something, but can verify the infromation (for example, in records), then you can use those as a basis for a NC.
An anecdotal assertion might be, as I said, a basis for further investigation. That doesn't alter the fact that the assertion itself shouldn't be considered objective evidence. Before a nonconformity statement can stand up, it must be supported by evidence directly observed.
 

somashekar

Staff member
Super Moderator
#17
Re: Degree of evidence

An anecdotal assertion might be, as I said, a basis for further investigation. That doesn't alter the fact that the assertion itself shouldn't be considered objective evidence. Before a nonconformity statement can stand up, it must be supported by evidence directly observed.
Would it mean that a NC statement can begin or end with " As stated by the responsible manager " being the evidence ... ?
 
Last edited:

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#18
Re: Degree of evidence

Would it mean that a NC statement can begin or end with " As stated by the responsible manager" being the evidence ... ?
When attending Lead Auditor training for TS 16949, an auditee's statements were certainly considered evidence and could be included as part of the NC description. We specifically practiced them.

That said, it is helpful to consider that the organization will very likely be interested in tangible evidence so I am disinclined to simply say "So-and-so said such-and-such" as a writeup because people can say anything. They may be mistaken from lack of insight, exaggerating, suffer momentary confusion and so on.

However, in event of a breakdown somewhere an investigation can, and should include testimony as part of the body of evidence.
:2cents:
 

Stijloor

Staff member
Super Moderator
#19
Re: Degree of evidence

When attending Lead Auditor training for TS 16949, an auditee's statements were certainly considered evidence and could be included as part of the NC description. We specifically practiced them.

That said, it is helpful to consider that the organization will very likely be interested in tangible evidence so I am disinclined to simply say "So-and-so said such-and-such" as a writeup because people can say anything. They may be mistaken from lack of insight, exaggerating, suffer momentary confusion and so on.

However, in event of a breakdown somewhere an investigation can, and should include testimony as part of the body of evidence.
:2cents:
Yes, statements of fact are considered audit evidence:

From ISO 19011:

3.3
audit evidence

records, statements of fact or other information, which are relevant to the audit criteria (3.2) and verifiable

NOTE Audit evidence may be qualitative or quantitative.
Emphasis mine.

Stijloor.
 

Marcelo

Inactive Registered Visitor
#20
Re: Degree of evidence

Before a nonconformity statement can stand up, it must be supported by evidence directly observed.
Not to be picky, Jim, but I do not think that you need to directly observe a finding to use it to report a NC.

The definition of audit evidence from 19011

audit evidence
records, statements of fact or other information, which are relevant to the audit criteria (3.2) and verifiable
clearly means that you can have anything as evidence as long as it's relevant to the audit and verifiable.

In fact, I woould say that that's exactly why records where created - so that a system can be audit even if if the auditor does not directly observe something. Records shows that things were done and you simply audit with this supposition.
 
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