SOP FOR REPORTING OF INVESTIGATION
PURPOSE: To lay down a procedure for reporting of investigation.
SCOPE: This SOP is applicable to for the quality related failures of product, which do not meet the acceptance criteria.
RESPONSIBILITY:
Personnel of concern department are responsible for the Quality Related failures of product.
Concern-HOD or designee shall investigate and conclude the investigation to find root cause
Head QA or designee shall evaluate root cause and ensure the compliance and implementation of agreed corrective and preventive actions.
ACCOUNTABILITY: User department Head and Head-Q. A Shall are Accountable for implementation and compliance of SOP.
PROCEDURE
Product failures shall be reported in the “Failure Investigation Report” form.
The “Failure Investigation Report” form shall be issued by QA on request. A “Corrective and Preventive action” form shall be issued along with “Failure Investigation Report” form.
Before issue the failure investigation report shall be numbered serially in the calendar year with an identification code of department.
A typical Failure investigation shall be numbered as: FI/XX/ZZ-YYY
Where, FI: Failure investigation
XX: Department code
ZZ: Last digit of the calendar year
YYY: Serial number commencing at 001 in the calendar year.
The “Failure Investigation Report” number and details of failure shall be recorded in the failure investigation log.
“Failure Investigation Report” form shall be filled by concerned department.
The initiator shall fill the details like Department, Name of product, Batch No. and Date on the form, along with the description of the failure and source information.
The initiator shall sign and forward the form to the concerned department.
Concerned department shall fill the investigation of failure column with details of document review and probable reason and proposed corrective and preventive actions. If required additional sheets can be attached. The department head shall sign and forward the form to Head QA.
The investigation shall be conducted by concerned department Head in consultation with Head QA. Investigation team shall be cross functional team comprising of members from following functions like Initiating department, Quality Assurance, Quality Control, Manufacturing, Engineering, Formulation & Development and Warehouse etc.
Depending on the nature of the failure, the investigation team shall list down all the documents which need to be reviewed as part of the investigation like Batch Manufacturing Records / Batch Packaging Records of the specific batch for critical parameters.
Control Samples:
Analytical data of RM, PM
In process & Finished products
Stability data
Cleaning records
Instrument / Equipment calibration /qualification status
Personnel training record
Interview of involved personnel
Trend data
Note: The personnel of Production, QC and QA shall carry out the review of the documents
Head QA shall review the investigation of the failure column with details of document review and the probable reason for failure by using investigation tools like
Brain storming
Affinity Diagram or chart
Root cause and Effect Analysis:
Fish bone diagram/ Ishikawa diagram (Cause and effect diagram)
5 why
Impact assessment
Conclusion
Brain storming:
Brainstorming is a situation where a group of people meet to generate new ideas and solutions to find a conclusion for a specific problem. In this session people are able to think more freely and they suggest as many spontaneous new ideas as possible. It is to be performed immediately upon receipt of complaint/ deviation. Following question to asked but not limited to:
What happened? Describe actual problem. Provide Details of the defect. What has happened to the product?
When did it happen? When was the defect discovered?
Where did it happen? What were the situation/ location?
What is the impact? What is the impact over the product? What could be impact over the batch/ other batches in market?
What could be the probable causes that have lead to this defect/deviation?
Whether similar nature of defect reported in past?
Was any breakdown observed in the equipment or instrument during the manufacturing?
Has any in-process check failed during manufacturing?
Was any deviation reported during manufacturing?
Note: Based upon the brain storming session, Fish bone diagram is to be derived.
Affinity Diagram or chart:
The affinity diagram organizes a large number of ideas into their natural relationships. It is the organized output from a Brainstorming session. It can be used to generate, organize, and consolidate information related to a product, process, complex issue, or problem. After generating ideas, group them according to their affinity, or similarity. The affinity diagram organizes ideas with following steps:
Record each idea on cards or notes.
Look for ideas that seem to be related.
Sort cards into groups until all cards have been used.
Once the cards have been sorted into groups the team may sort large clusters into subgroups for easier management and analysis
Root cause and Effect Analysis :
Fish Bone Diagram or Ishikawa diagram (Cause and effect diagram)
Ishikawa diagrams also known as fish bone diagram in which the defect is shown as the fish’s head, facing to the right, with the causes extending to the left as fish bones the ribs branch off the backbone for major causes, with sub-branches for root-causes, to as many levels as required.
Analysis of Fish Bone diagram:
Man:
Educational Qualification
Experience
Association with Company
Workload
Machine:
Qualification
Preventive Maintenance
Breakdown
Calibrations
Measurement:
Inprocess checks
Release testing
Control sample testing
Stability testing
Material:
Raw material (API& Excipients)
Packing materials
Semi-finished Goods
Method:
Dispensing
Sifting
Granulation ( Dry & Wet Granulation)
Blending
Capsule Filling
Compression
Coating
Visual Inspection
Packing (Blistering, Bottle packing & Dry Syrup Filling etc.)
Mother nature (Environment)
Details of Temperature, RH and DP during the process & storage
5 WHY:
Based upon the probable root cause, conduct a 5 Why? Analysis to reach to root cause. For example but not limited to
WHY → High DT
↓
WHY → Over lubrication → WHY
↓
More mixing in force feeder
↓
WHY ← Slow machine speed with high feeder RPM ← WHY
↓
Parameters not defined in BMR
Review of complaint history:
Include details of any similar defect/ deviation reported in past.
What was the root cause of that defect?
What were the CAPA derived?
What is the status of those CAPA? What is the difference between current scenario and the past scenario?
Impact assessment:
Include the impact of this defect over other batches.
Were the batches manufactured in campaign?
Whether the defective RM/ PM used in this batch was used in other batches?
What is the recommendation for those batches?
Include the details of the impacted batches’- batch no. mfg. expiry, customer etc.
Whether any action is required to be initiated for the impacted batches.
Conclusion:
Include the actual root causes.
Include the review of complaint history.
Include details of impact assessment
All the Investigation tools mentioned above shall be used in case of any Market complaint, Product complaint and in case of any deviation to find out the root cause but not limited to. Other tools also can be used to find out the root cause for any problem. Based upon the root cause Appropriate CAPA shall be taken.
QA head shall be Performed a detailed investigation to identify the root cause for the reported non-compliance or failure in order to take an appropriate corrective action to avoid recurrence.
Based on the investigations concerned department Head shall document the findings and shall propose Corrective and Preventive actions to correct the failure and to avoid recurrence. The proposed Corrective and preventive actions shall be reviewed by Head QA.
Head QA shall evaluate all the relevant documents and the impact of failure on associated batches and on existing facility, system, equipment, documentation and suggest the necessary recommendations to correct the failure and to avoid the recurrence. Head QA shall sign on the form and a copy shall be forwarded to concerned department.
In case, where experiments are required to be conducted at Production / QC, necessary samples shall be withdrawn. Data shall be reviewed by QA.
Concerned department shall carry out the implementation of the Corrective and Preventive action by updating required documents and/or system.
Concerned department shall summarize the implementation of Corrective and Preventive actions and send the form to Head QA for comments.
Head QA shall review the corrective and preventive actions implemented and shall send the filled form to Head QA.
Head QA shall review and update the related documents, wherever applicable and verify the implementation of corrective and preventive action taken.
Failure investigation shall be closed by Head QA after verification of the implementation of CAPA.
REFERENCES
SOP FOR SOP
Handling of out of specification
Handling of CAPA SOP