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

K

Ka Pilo

#1
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 For example, outdated documents available at points of use.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 or 1 sample of outdated document found will suffice?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Degree of evidence

A single example is a nonconformity.

However, the decision of how to proceed with this nonconformity relies on various factors, such as the risk of failure introduced or enabled by this single nonconformity. If we were talking about purchase orders for office materials I would look for more than one example before calling for action to resolve. If, however we are referring to an inspection record following a repair to a nuclear station's cooling piping, a single errant document can and arguably should generate an action.
 
K

Ka Pilo

#3
Re: Degree of evidence

A single example is a nonconformity.

However, the decision of how to proceed with this nonconformity relies on various factors, such as the risk of failure introduced or enabled by this single nonconformity. If we were talking about purchase orders for office materials I would look for more than one example before calling for action to resolve. If, however we are referring to an inspection record following a repair to a nuclear station's cooling piping, a single errant document can and arguably should generate an action.
So, the standard gave the auditors the sole discretion to decide whatever amount of evidence they deem sufficient based on risk.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Re: Degree of evidence

The standards I work to (ISO 9001, 14001, OHSAS 18001, ANSI/ISO/IEC 17025 and TS 16949) do not place limits or indeed cite specifics of any kind as this goes, so yes the auditor is charged to determine a condition of conformity/nonconformity exists based on objective evidence.
 

qusys

Trusted Information Resource
#5
Re: Degree of evidence

So, the standard gave the auditors the sole discretion to decide whatever amount of evidence they deem sufficient based on risk.
The registrar auditors have their own rules and can decide for a major or minor ncn. For example, if there a repetive evidences of outdated or wrong documentation in the several processes examined, they can decide to elicit a major non conformity based upon the sistematic evidences collected.
In other case if there is one clear evidence, for example internal audit planning missing, it is sufficient only this to raise a major.
It is a question of balancing .
This is my experience that I have seen in lots of audits.:bigwave:
 
K

Ka Pilo

#6
Re: Degree of evidence

The standards I work to (ISO 9001, 14001, OHSAS 18001, ANSI/ISO/IEC 17025 and TS 16949) do not place limits or indeed cite specifics of any kind as this goes, so yes the auditor is charged to determine a condition of conformity/nonconformity exists based on objective evidence.
What is the definition of "objective evidence" under ISO 9001?
 

Jim Wynne

Staff member
Admin
#7
Re: Degree of evidence

What is the definition of "objective evidence" under ISO 9001?
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.
 
K

Ka Pilo

#9
Re: Degree of evidence

The registrar auditors have their own rules and can decide for a major or minor ncn.
IMHO, all the registrars should expressly adopt a uniform rules for the guidance of all parties concerned e.g. organization, auditors etc
 

Stijloor

Staff member
Super Moderator
#10
Re: Degree of evidence

IMHO, all the registrars should expressly adopt a uniform rules for the guidance of all parties concerned e.g. organization, auditors etc
They do and have.

ISO IEC 17021:2011.

Conformity assessment — Requirements for bodies providing audit and certification of management systems.

Stijloor.
 
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