sop for Non Conformance

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sop for Non Conformance

1.0 Objective
To lay down a procedure for non conformances observed in all areas of operation and all departments.
2.0 Scope
This Standard Operating Procedure is applicable for Non Conformances observed in all departments to be followed at

formulation plant of abc Pvt. Ltd.
3.0 Responsibility
3.1 Concerned department Officer / Executive shall be responsible for receiving non conformance report and for further action.
3.2 Head / In charge Quality Assurance or his/ her designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
NCR : Non Conformance Report
BPCR : Batch Production and Control Record
R & D : Research and Development
5.0 Procedure
5.1 Initiation of Non Conformances are the observation / incident
5.1.1 Non Conformance which not complies to the procedure, system and equipment

shall be recorded as per Annexure-1.
5.1.2 If any Non Conformance observed, then same shall be recorded in NCR by the observer.

Observer shall write the detail of non-conformance and same shall be handed over to

concerned Officer/ Executive of the department.
5.1.3 Filling of NCR shall be carried in reference of SOP, BPCR, process guideline and

other regulatory and In-house quality management system as applicable for filling of NCR.
5.1.4 Concerned Officer/ Executive shall investigate the root cause of non-conformance and

suggest the suitable preventive action in consensus with their Concern Manager.

Head QA shall take lead to investigate the root cause of non-conformance and to

implement the corrective and preventive action.
5.1.5 Concerned Officer/ Executive shall also define the responsibility and target completion

date for the suggested preventive action so that same shall not repeat in future.
5.1.6 If NCR related to batch processing/ activity, then deviation shall be filled by concerned

department as per SOP No. BBL/QA/SOP/008 for further activity.
5.1.7 Concerned department manager shall review the process if required to

overcome the non-conformance in future.
5.1.8 If preventive action and process review needs any additional improvement or

modification in process/ equipment/ system, then QA Head shall notify the same

with concerned department head.
5.1.9 If any additional support required from corporate QA/ R & D, then QA shall

communicate for same to concerned department.
5.1.10 Final review shall be done by QA Head before closing of NCR.
5.1.11 Concerned department head with QA, shall organize and conduct need base

reinforcement training for non-conformance encountered.
5.1.12 After closing of NCR, same shall be submitted to QA documentation cell.

QA Officer/ Executive shall assign unique NCR number. Numbering system shall be of 10 alphanumerical characters like
NCR/XX/YYY where,
NCR stands for Non Conformance report
“/ ” stand for separator
XX stands for financial year
“/” stand for separator
YYY stands for serial number of report like 001, 002
5.1.13 QA documentation cell shall maintain the filled NCR record after closing.

QA Officer/ Executive shall maintain the NCR Log after closing as per Annexuer-2.
5.2 Category f non-conformance:
5.2.1 Non-conformance can be classified into Critical, Major and minor based on observation as given below.
Critical Observation:
• Product failure / Product recall
• Market complaint
• Adverse drug reaction
• Regulatory action
• Significant change in product stability
Major observation:
• Breakdown of equipment / system.
• Yield discrepancy
• Company image
Minor observation:
• Missing out a product literature in a unit pack.
• Smudgy coding
• Missing of tablet / capsule in strip/blister, missing of strips in carton, missing of

cartons in shipper, transportation breakage

6.0 Forms and Records
6.1 Non conformance report – Annexure-1.
6.2 NCR Log – Annexure-2.
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Quality Control, Personnel & Administration, Production, Warehouse, Engineering
8.0 History