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 :
· Personnel & Administration