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(