Procedure
Preamble
A Non- conformance is in essence, something that does
not meet specifications” A deficiency in a characteristic, product
specification, process parameter, record, or procedure that renders the quality
of a product unacceptable, indeterminate, or not according to specified
requirements.
Correction- Action to eliminate a detected
nonconformity. A correction can be made in conjunction with a corrective
action.
Corrective Action- Action taken to eliminate the cause
of a non conformance that has occurred, and
prevent re occurrence of
the non conformance. (In
this case a non conformance has already occurred).
Preventive Action- Action taken to eliminate the cause
of a potential non conformance and prevent the non conformance from occurring. (In this case a non conformance has not yet
occurred).
Non-conformance Report (NCR)’ shall be generated in
case of the following types of non-conformance observations:
Any GMP
related non-compliance observations.
Non-compliance
with in-process specifications.
Falsification
/ misrepresentation of document or data.
Unauthorized
changes.
Any non-conformance observed shall be recorded in
‘Non-conformance Report’.
QA department shall issue the format of NCR to concern
department/personnel.
The non-compliance observation shall be classified into
critical, major and minor category.
Critical observations are those which possess a risk of
(but not limited):
Lead to
Product failure / recall
Lead to
Market complaints
Lead to
Serious adverse health consequence or death.
Regulatory
action
Major observations are those which possess a risk of
(but not limited):
Breakdown
of equipment/system
Yield
discrepancy
Major discrepancy like absence or
complete breakdown of required systems are
observed.
Minor observations are those which possess a risk of
(But not limited:
Isolated
failure to comply with specified requirement.
Missing
out of a product literature in a unit pack could be considered as a minor.
Difference
in Font size of overprinting details during packing operation.
The concerned activity may be stopped immediately after
raising of critical/major/Minor non-conformance report. Concerned department
shall take immediate actions and record the same by selecting either stop
activity or continue activity in immediate action along with brief
justification & description.
Concerned department Head shall investigate the root
cause of non–conformance and propose immediate corrective action or otherwise
define the responsibility with brief description & justification and target
completion date (TCD) for corrective action.
Concerned Department Executive/Designee Shall take
immediate action and record the same by selecting either stop activity or
continue activity in immediate action section along with brief justification
and description. same shall be intimated to other department for further
evaluation and investigation.
Investigation of Non-Conformance
if in process product or finished product is
non-conforming, then it should be quarantined with ‘HOLD’ shifted to designated
area in supervision of QA personnel
Root cause analysis shall be carried out for
Non-conformance by RCA Team as per SOP of Root cause analysis.
Preventive action shall be proposed by department head
in consensus with QA to avoid recurrence in future.
QA personnel shall give the detail of similar type of
Non-Conformance if reported Previously (if any).
After review comments of QA personnel, Non-conformance
report shall be intimated to other department for their comment (if required)
for impact of Non-Conformance on their department procedure.
Duly filled investigation report shall forward to
Head-QA/Designee for their review and comments.
Finally, Non –Conformance Report shall be approved by
Head –QA.
NCR shall be closed within 7 working days, if not closed
proper justification should be given. if corrective action and progress review needs any additional improvement, QA shall
notify the same to concerned department Head and ask for a revised TCD.
For corrective / preventive action requiring management
resolution, the NCR shall be forwarded to management, if required.
A photocopy of product related NCR shall be attached
with concerned records.
QA Head in coordination with concerned department Head
shall organize and conduct need based
training for non–conformance
encountered.
