Saturday, November 20, 2010

Inspection for self inspection program

1.0         Purpose     :       To provide instruction for Self Inspection program.

2.0         Objective  :        To provide a documented procedure for Self Inspection program.

3.0          Scope     :            This procedure is applicable for self-inspection program.


4.0         Responsibility   :
·              Primary: Officer – QA / Officer-Store
·              Secondary: Officer – QA Manager.

5.0       Procedure   :
·        Routine inspection
Ø           A trained Quality Assurance person(s) takes routine visit to processing area for the monitoring of routine production activities.
Ø           Following area / activities shall be covered in routine inspection.
Ø           Cleanliness of area / equipment / personnel etc.
Ø           Identification on equipment/containers /rooms.
Ø           Calibration of equipments /instruments.
Ø           Processing area for processing activity.
Ø           Filling Batch Manufacturing Records.
Ø           Reference to design procedures, specification, and test procedures, standard operating procedure.
Ø           Hygiene practices for handling of equipments /products.
Ø           In case of any discrepancy observed note down the observations in book and take the initial of concerned area in-charge for acknowledge. In the case of major discrepancy inform to Quality Assurance Head and respective Department Head for immediate action.
Ø           Quality Assurance department in consultation with other concern department shall decide the course of action.


·        Scheduled for Audit
Ø           Audit schedule shall be made by Quality Assurance Department concerned with other department Heads.
·        Audit Team
Ø           Audit team shall be made from local staff, expertise and knowledgeable in their field of activity and familiar with GMP.
Ø           An expert from outside other than local staff but in the same organization familiar with the GMP requirements and expertise may be appointed.
Ø           The team shall notify the auditors’ 10 days prior to audit to ensure routine work is well organized and planned.
Ø           A member of the audit cannot audit his own area of activity.
Ø           The audit team can call for all such relevant records, inspect sites, operation interact with people cutting across hierarchy to place factual position for management review and action.
Ø           Audit team can break up in 2 or more team and carry out inspection separately.
Ø           Department wise separate audit checklist shall be prepared.
Ø           Findings and observation report in writing should be clear, unambiguous and with facts and reference.
Ø           The approach of the self-audit team shall be such that information is willingly volunteered and open.
·        Audit Frequency  :
Ø           Two Times in a Year.
·        Audit Checklist.
Ø           Separate audit checklist shall be made for each department, e.g. Production, Maintenance, Stores, and Quality Control.
·        Inspection Report
Ø           Audit report shall be made by QA with coordination of other team members.
Ø           Audit report should mention.
Ø           Audit observations.
Ø           Suggestion for corrective action.
Ø           Name of responsible personnel who will take the corrective action of respective department.
Ø           The audit report shall be given to each of the section(s), concerning their activity   the plant manager shall receive the copy.
Ø           Discuss the findings with auditee or concerned department head.
Ø           All the audit team members are required to revert with their audit report.
Ø           In case major deviation observed in auditing a deviation analysis need to be conducted.
Ø           A copy of deviation analysis report is submitted to plant Manager
Ø           Submit the report to Quality Assurance. Quality Assurance to log the self-inspection report in sequential log.
Ø           Co-ordinate with Dept. being audited for corrective and preventive action.
Ø           Based on findings prepare summary of preventive and corrective action plan by Quality Assurance In-Charge.
Ø           If preventive actions are of long term, appoint a person for the follow up of Preventive action.
Ø           Review the results of preventive actions.
Ø           Close the self-inspection report as per the closure checklist.

6.0      Reference Document  :
v     Audit schedule
v     Audit team
v     Audit Checklists (Production, Stores, Maintenance & QC)
v     Audit report format
v     Audit compliances format
v     Audit closure format





7.0      Abbreviations   :
·          QA   = Quality Assurance department
·          SOP = Standard Operating Procedure
·        GMP = Good Manufacturing Practices

8.0      Copies to  Distribution Sites  :
·        QA
·        QC
·        Stores
·        Production
·        Engineering
·        Personnel & Administration 

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