SOP ON CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION)
PURPOSE: To lay down the standard operating procedure for Corrective Action and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems.
SCOPE: This SOP is applicable to define and implement the CAPA for investigation outcome of events such as Non-conformances, Market complaints, Product recalls, Deviations, Out of Specification results, Out of Expectation results, outcome of Annual Product Review (APQR) and Audit/Inspection Observations (Including self-Inspection, External, Customer and Regulatory Audits).
RESPONSIBILITY: Concerned Department Executive: To initiate CAPA form.
Concerned Department Head/Designee: To carry out all the activities of the CAPA such as
carrying out Remedial Actions, carrying out Root Cause Investigation and Identifying Action Items.
QA Executive/Designee: To issue CAPA to initiator/Implementer and logging, The details of CAPA in the log and to monitor the CAPA program with concerned department head and implementer.
Implementer: To implement the actions
Head QA: To verify the details for its adequacy accept or reject the CAPA and ensure effectiveness of CAPA.
ACCOUNTABILITY: The accountability of implementation and compliance of SOP lies with the concerned departments and QA Head.
PROCEDURE: All Departmental Managers shall be responsible for reporting of non-conformances, carrying out investigation under the guidance of the Head QA. This is responsibility of all HOD’s to take corrective action authorized by QA Head and to make necessary records of corrective action taken.
The Quality Assurance assigns a tracking number to the Corrective and Preventive Action CAPA No. CAPA-YY-001
Where YY stands for the last two digit of the Year, in which Corrective and Preventive Action
Request is raised
001 stands for the continuous serial number of the Corrective and Preventive Action Request being raised in the respective year.
QA Head shall be responsible for co-coordinating the corrective and preventive action, and
closing of nonconforming and corrective action request reports.
Investigation of non-conformances and corrective action:
Various types of non-conformances, procedure for communication of non-conformances together
with corrective action to be taken are indicated below:
Nonconformance of product: Nonconformance of product shall be dealt for handling of “control of non-conforming products and materials and destruction”.
Non-conformance of materials: Non-conformance of materials shall be dealt with according to the steps indicated below.
The Initiating department shall be reported the non-conformance report of any material along with ‘Corrective and Preventive Action Request Form’ to QA department.
The Head of QA shall investigate the matter in co-ordination with concern Head of department and Quality Control Head. QA Head shall suggest reanalysis/ rejection of the non conforming material, if required. The reports of nonconforming materials shall be communicated to the QA Head along with result of analysis and supplementary records. QA Head shall take up the matter with the supplier through Purchase Department to improve the quality of materials of the future supplies.
Nonconformance of documentation:
The Head of Quality Assurance shall be responsible for review of the Batch Manufacturing Records/ Product Packaging Records, including analytical Reports of all the batches of all the products manufactured.
Quality Assurance Head shall bring to the notice of the Production Head and the Quality Control Head, the non-conformances observed in the preparation of these records and ensure to correct the records through the respective Departmental Heads before release of the batch.
If the non-conformance is the result of inadequacy in any document, QA Head shall suggest revision in the document / procedure in consultation with the concerned Department Head as per, for handling of ‘corrective action and preventive action register’.
Market Complaints: Customer compliance regarding nonconforming product shall be handled as per SOP for ‘Handling of Market Complaint’ QA Head in consultation with HOD’s of concerned department shall take necessary corrective action such as making a report to the management, writing to the customer, suggesting a change in the design of the product / pack if required.
Product Recalls: If the investigation of the compliant reveals that the product is not suitable for use, QA Head shall arrange to recall the product according to the procedure detailed in SOP, “Product Recall”.
Deviations: Deviations regarding approved specifications and procedure and also arising from malfunctioning equipment shall be handled as per SOP for ‘Handling of Deviation’.
OOS: OOS applicable to situations arising in the event of a product failing to meet
the laid down specification & is limited to validated products, methods, processes and sample received
from plant, tested accordance with existing pharmacopoeia or in-house methods and having laid down specifications shall be handled as per SOP “Handling of Out of Specification (OOS) and Out of Trend (OOT) ”.
OOT: OOT procedure applies to all test results obtained for raw materials, in- process validation, finished product and product yield in which results fall within specification but there is a difference from normal trend which shall be handled as per SOP “Handling of Out of Specification (OOS) and Out of Trend (OOT)”.
Non-conformances observed during Outcome of APQR: Non-conformances observed during APQR shall be recorded and CAPA shall be decided.
Audit observations: Non-conformances shall be recorded in the Internal Audit Report as described the procedure of Self Inspection. The corrective action as agreed by the respective Departmental Head shall be recorded in the ‘Self Inspection Report’ along with compliance action plan.
If Non-conformances recorded in the External, Customer and Regulatory Audit reports, QA designee in-consultation with the Production and QC designee shall narrate the CAPA along with compliance action plan.
QA Head will review and verify the corrective actions taken & all improvement completion details shall be recorded.
Preventive Action: Preventive action shall be planned and implemented on the basis of analysis of historical data of nonconforming products, processes, quality records quality audit reports, deviation to eliminate potential causes of non-conformities.
Information for potential product quality problems shall be collected from quality review of finished products (Stability Study) and suggestions from the manufacturing department.
The Quality Control Head shall send a stability study report to the QA Head with a “Corrective and Preventive Action Request Form”, if the results of the study indicate possibility of nonconformance with the specification.
The Departmental Head (Production Head) shall suggest improvements required in the product in situations leading to quality problems such as, processing difficulties faced and / or frequent re-processing of the batch required in order to meet the release specifications.
The QA Head on his deputy in consultation with the customer re-formulates the product and carryout stability study on such product.
Change in formula / process shall be carried out by the Production Head after obtaining approval from the Head of QA as per SOP ‘Change Control Management’
Information regarding potential quality problems shall also be collected from the periodical internal quality audit reports and from customer complaints (market complaints). Procedure detailed in respective standard operating procedures shall be referred.
The noncompliance and / or inadequacy of the system as recorded in the internal audit report shall be reviewed by the Departmental Head and QA Head.
Necessary Standard Operating Procedures shall be revised to improve quality management system as described in the SOP. “SOP for SOP”.
Management of Corrective Action and Preventive action
The Head of QA shall maintain a register of all nonconformance/ noncompliance reports and the corrective actions taken, ‘Corrective Action and Preventive Action Register’.
In case during implementation, it is required to modify either the scope of CAPA, or implementer, a request shall be given to QA along with justification, revised action, implementer name and date, same shall be updated by QA designee by taking an addendum CAPA form. Copy of addendum CAPA shall be attached to the respective parent document through which the CAPA was identified.
In case a CAPA could not be completed by the target date, the implementer shall submit revised target date in format for ‘CAPA target date extension request” with the appropriate justification.
A copy of addendum CAPA shall be taken to put revised target date and same shall be attached to the respective parent document through which the CAPA was identified.
Respective department Heads shall follow all corrective and preventive actions as suggested by QA Head.
The corrective and preventive action shall be reviewed by the Head of QA to ensure effectiveness of each action taken and close the Corrective and Preventive Action Request Form
Effectiveness of CAPA: The review of the effectiveness shall be recorded in format “Effectiveness of CAPA”.
QA shall review the effectiveness of CAPA along with respective department, on a regular basis.
The CAPA related to changes/improvement in practice or procedures shall be covered as a part of the effectiveness checks.
The effectiveness check shall be carried out based on intensity of CAPA or 30 days of its closure.
Any action plan arising out of the effectiveness check shall be completed within 10 working days.
After final review of “Effectiveness of CAPA” by Head QA enclose the Annexure with the respective parent document through which the CAPA was identified.
The CAPA effectiveness shall be applicable for any planned or unplanned deviation, Market complaint and Risk assessment.
The CAPA form after completion of review by Head QA shall be submitted to senior management or discussed quarterly in Management review meeting.
In case of extension of dates for the closure of CAPA shall be used.
REFERENCE: SOP FOR SOP.