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Difference Minor and Major Non Conformity

Minor nonconformities are isolated incidents that are unlikely to result in quality management system failure or the delivery of nonconforming products or services. Examples include a drawing marked up with unauthorized changes or an inspection instrument that is past its calibration date. Major nonconformities represent serious problems in the system, such as a total breakdown of controls or procedures, and put an organization at risk of shipping nonconforming products or failing an audit. Between these two are less serious nonconformities that, when considered together, could identify a system failure and constitute a major nonconformity. Auditors must consider all evidence to make an informed judgment about whether a process or subsystem is failing.

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896 views

Difference Minor and Major Non Conformity

Minor nonconformities are isolated incidents that are unlikely to result in quality management system failure or the delivery of nonconforming products or services. Examples include a drawing marked up with unauthorized changes or an inspection instrument that is past its calibration date. Major nonconformities represent serious problems in the system, such as a total breakdown of controls or procedures, and put an organization at risk of shipping nonconforming products or failing an audit. Between these two are less serious nonconformities that, when considered together, could identify a system failure and constitute a major nonconformity. Auditors must consider all evidence to make an informed judgment about whether a process or subsystem is failing.

Uploaded by

chrisn786
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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What is a Minor Non Conformity?

The definition of a MINOR non conformity:


Failure to conform to a requirement which (based on judgement and e!erience" is not li#ely to result in $uality
Management system Failure
% single obser&ed la!se or isolated incident
Minimal ris# of nonconforming !roduct or ser&ice
'am!le: % drawing mar#ed u! with unauthorised changes
% !urchase order released without re&iew and a!!ro&al
%n ins!ection instrument !ast its calibration date
% Training record not a&ailable
Minor non conformities ha&e little li#elihood of allowing nonconforming !roduct or ser&ice to be deli&ered or
causing a brea#down of system control( It does indicate that there are occasional la!ses that must be formally
addressed through correcti&e action(
What is a Major Nonconformity?
The definition of a M%)OR nonconformity:
Total brea#down of system* control* or !rocedure
%bsence of an I+O ,--.:/--0 requirement
% number of minors related to the same clause
% nonconformity that would result in !robable shi!ment of nonconformity or unins!ected !roduct
% condition that may result in the failure or materially reduce the usability of !roduct intended for !ur!ose1
% non2conformity that e!erience and judgement indicate will li#ely result in $uality Management system failure
or materially reduce its ability to assure controlled !rocesses and !roducts
'am!les: No documented !rocedure for any required element of the standard
3ocument changes routinely carried out in an unauthorised 4controlled manner
5ritical !urchases made form une&aluated su!!liers
6roduct dis!atched without required ins!ection and tests
Major re!resents serious !roblems in the system that must be addressed with attention and resources on a
!riority basis( It !uts the business at ris# with customers and com!liance satisfaction(
On certification audits (third 6arty"* the auditor may threaten to sus!end an organisations certificate and later
re&o#e it* if the organisation fails to address the major* does not address it in a timely manner* or just su!erficially
corrects it(
7etween these two etremes a number of less serious nonconformities* when considered together* may identify a
system failure and hence a Major nonconformity(
%s auditors we need to consider all the e&idence a&ailable to see whether there is a !rocess or sub2system of the
$uality Management system is failing( It is the combination of all the e&idence that will contribute to the informed
judgement that we as auditors will be required to !resent to the organisation(

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