1.0 OBJECTIVE To lay down a procedure for root cause analysis related to exception like incident, deviation, market complaints, product recall & audits observations etc.
2.0 SCOPE This SOP shall be applicable for investigating the root cause analysis of incident, deviation, market complaints, product recall & audits observations of pharmaceuticals products.
3.0 RESPONSIBILITY Concerned department which is Initiate the incident, deviation & complaints shall be responsible to report the same.
2.0 SCOPE This SOP shall be applicable for investigating the root cause analysis of incident, deviation, market complaints, product recall & audits observations of pharmaceuticals products.
3.0 RESPONSIBILITY Concerned department which is Initiate the incident, deviation & complaints shall be responsible to report the same.
Initiator department head & Head-QA shall nominate the investigation team for detect the root cause & responsible for review of root cause analysis report.
Head- Quality is responsible for review & approval of root cause analysis report & compliance of SOP’s.
Head- Quality is responsible for review & approval of root cause analysis report & compliance of SOP’s.
4.0 DEFINITION (S)
4.1 Root cause Analysis : It is a method of problem solving used for identifying the root cause of faults or problems.Or
A technique used to identify the conditions that initiate the occurrence of an undesired activity or state. The process of problem solving used to identify the underlying or initiating source of a non conformance.
5.0 PROCEDURE
5.1 Investigation shall be performed for exceptions like Non conformance, deviation, complaints product recall & audits observations etc
5.2 OOS / OOT investigation shall be performed as per respective SOP.
5.3 Initiator Head department & Head–QA shall nominate the investigation team for carrying the investigation. Investigation team shall be cross functional on basis of nature of problem identified.
4.1 Root cause Analysis : It is a method of problem solving used for identifying the root cause of faults or problems.Or
A technique used to identify the conditions that initiate the occurrence of an undesired activity or state. The process of problem solving used to identify the underlying or initiating source of a non conformance.
5.0 PROCEDURE
5.1 Investigation shall be performed for exceptions like Non conformance, deviation, complaints product recall & audits observations etc
5.2 OOS / OOT investigation shall be performed as per respective SOP.
5.3 Initiator Head department & Head–QA shall nominate the investigation team for carrying the investigation. Investigation team shall be cross functional on basis of nature of problem identified.
5.4 For an effective investigation of exceptions following steps shall be followed.
5.4.1 The problem shall be defined for which the investigation is required.
5.4.2 Collect all the information/evidence related to the problem.
5.4.3 The investigation process shall follow a clearly defined procedure to identify the true cause associated with the problem.
5.4.1 The problem shall be defined for which the investigation is required.
5.4.2 Collect all the information/evidence related to the problem.
5.4.3 The investigation process shall follow a clearly defined procedure to identify the true cause associated with the problem.
5.4.4 Appropriate tool like Fish-Bone analysis (Ishikawa diagram), Brain storming, Why-Why analysis to be used for investigation (as applicable) .
1. 5- why concept
2. Brain stroming
3. Fish bone diagram
5.4.5 Investigation shall be done by review of concerned document i.e. BPR, logbooks, relevant SOPs, analytical data, raw data, stability data, preventive & breakdown maintenance data, calibration records, validation reports & any other relevant documents shall be reviewed to collect maximum possible related data.
5.4.6 If required necessary interrogation shall be done up to doer/performer level to find the route cause.
5.4.7 After going through all relevant documents & data collected through the discussions with relevant personnel, investigation team shall suggest the next step such as re-sampling ,retesting, extra testing & any other measure required (Wherever applicable) to complete the investigation.
5.4.8 Based upon investigation outcome, team shall identify the root cause of the exception.
5.4.9 After identification of root cause of the problem impact/Risk assessment shall be performed , wherever applicable.
1. 5- why concept
2. Brain stroming
3. Fish bone diagram
5.4.5 Investigation shall be done by review of concerned document i.e. BPR, logbooks, relevant SOPs, analytical data, raw data, stability data, preventive & breakdown maintenance data, calibration records, validation reports & any other relevant documents shall be reviewed to collect maximum possible related data.
5.4.6 If required necessary interrogation shall be done up to doer/performer level to find the route cause.
5.4.7 After going through all relevant documents & data collected through the discussions with relevant personnel, investigation team shall suggest the next step such as re-sampling ,retesting, extra testing & any other measure required (Wherever applicable) to complete the investigation.
5.4.8 Based upon investigation outcome, team shall identify the root cause of the exception.
5.4.9 After identification of root cause of the problem impact/Risk assessment shall be performed , wherever applicable.
5.4.10 Designated person from QA shall conform the authenticity & completeness of the data & analyze the data to identify potential product & quality problems for which corrective action & preventive actions are required.
5.4.11 CAPA shall be decided based on scientific & logical justification to prevent future re-occurrence of the similar problem.
5.4.12 After completion of investigation of all possible/probable cause, the team/designee shall prepare a final root cause analysis report within 30 days from date of initiation of investigation, wherever applicable, CAPA shall be handled as a part of source documents.
5.4.13 If the investigation followed by report preparation is not completed within 30 days, interim report shall be submitted to QA by explaining the reason & justification for extension.
5.4.14 The approved comprehensive investigation report shall be enclosed to its reference source documents.
5.4.11 CAPA shall be decided based on scientific & logical justification to prevent future re-occurrence of the similar problem.
5.4.12 After completion of investigation of all possible/probable cause, the team/designee shall prepare a final root cause analysis report within 30 days from date of initiation of investigation, wherever applicable, CAPA shall be handled as a part of source documents.
5.4.13 If the investigation followed by report preparation is not completed within 30 days, interim report shall be submitted to QA by explaining the reason & justification for extension.
5.4.14 The approved comprehensive investigation report shall be enclosed to its reference source documents.
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