ISO
9001:2015 QMS Awareness – Improvement – Nonconformity and corrective action
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Nonconformity = Non-fulfilment of a requirement
Nonconformity = Deviation from a specification, a standard requirement
or an expectation
Correction = An action to eliminate a detected nonconformity
Corrective action = An action to eliminate the cause of a nonconformity
Corrective action = An action to prevent recurrence of the nonconformity
Correction focuses on rectifying the immediate nonconformity, while
corrective action aims to eliminate the root cause of the nonconformity and
prevent its recurrence.
The requirements related
to nonconformity and corrective action mentioned in ISO 9001:2015 QMS standard (clause
10.2) are applicable when a nonconformity occurs (happens / takes place /
exists / be found to be present) and arising from complaints.
The purpose of the requirements
related to nonconformity and corrective action mentioned in ISO 9001:2015 QMS
standard (clause 10.2) is to eliminate – (i) The causes of nonconformity, (ii)
Correct the nonconformity to conformity.
The organization needs
to react to the nonconformity (as applicable) – (i) Take action to control and
correct the nonconformity, (ii) Deal with the consequences / effects), (iii)
Evaluate the need for action (by reviewing and analyzing, determining the
causes, determining if similar nonconformity exists or could potentially occur)
so that the nonconformity does not recur / occur elsewhere, (iv) Implement any
action required, (v) Review the effectiveness of corrective action taken, (vi) Update
risks and opportunities determined during planning, if necessary, (vii) Make
changes to the quality management system, if necessary.
Corrective action needs
to be appropriate to the effect of the nonconformity encountered.
The organization needs
to retain documented information (records) – (i) Nature of nonconformity, (ii)
Any subsequent action taken, and (iii) Result of corrective action taken.
The requirements (regarding
nonconformity and corrective action) basically relate to learning from errors
to prevent their repetition. The following process can be a suggestive way –
(i)
Begin with identification
of a problem or nonconformity
(ii)
Continue with
identification of the root causes of the problem or nonconformity
(iii)
Plan corrective action initiatives
(iv)
Start corrective action
for the root cause
(v)
Check the result of the
corrective action taken
(vi)
If desired results not
achieved after checking, carry out root cause analysis again and plan-do-check-act
cycle process for correction
(vii)
In case problem is not
solved or nonconformity is not eliminated then to control such nonconforming product
(output), please deal as per requirements of clause 8.7 (control of
nonconforming outputs) that include segregation, containment, return,
suspension, informing the customer, obtaining authorization for acceptance
under concession
(viii)
Standardize the
improvement in the similar related activities – Use of learning from the
corrective action for the improvement of the organization’s processes
Think of
the following Questions
(1)
What is a nonconformity?
(2)
What is corrective action?
(3)
How will you proceed when you find a
nonconformity?
(4)
How will you deal with situations when you are
not able to get desired results after taking corrective action?
Best wishes,
Keshav Ram Singhal
Please have your comments /
reaction.
To train your employees with ISO
9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN:
B093YFFY7Z), which is available worldwide at Amazon. Please
search this Training Handbook in Amazon Website of your country.
You may also supply your
employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information
(eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/
(ii) Applying Risk-based Thinking in an Organization Implementing ISO
9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/
Thanks.
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