1.0 PURPOSE:
This procedure describes the structured approach and methodology to conduct an investigation of any discrepancies in GMP compliance/quality systems with the objective of determining the potential root cause, impact/risk assessment, and appropriate corrective and preventive action to avoid reoccurrence.
2.0 SCOPE:
Applicable to the investigation of
1. Deviations
2. Non-conforming Products
3. Market Complaints
4. Product Recalls
5. Self-Inspection observations
6. Product Quality Reviews
7. Internal Data Reviews
8. Validation results
9. Inspectional Findings
10. Out-of-Specification Test Results
11. OOS result at Contract testing lab
12. Lab Deviations
13. Out-of-trend results in manufacturing and testing activities.
14. Independent investigations and investigation of any other product quality issue etc.
3.0 RESPONSIBILITY:
All Departmental Heads
4.0 DEFINITIONS:
4.1 Investigation: A simple systematic process for finding the underlying harmful, factor (cause) of a discrepancy failure, impact assessment, and appropriate corrective and preventive action.
4.2 CAPA (Corrective and Preventive Action): A systematic approach that includes actions needed OR Corrections (correction), prevents recurrence (corrective action), and eliminates the cause of potential (preventive action), non-conforming product, and other quality problems.
4.3 Discrepancy: Datum of result outside of the expected range, an unfulfilled requirement may be called non-conformity, defect, deviation, out-of-specification, out-of-trend, etc.
5.0 PROCEDURE:
The key to a successful investigation is to record every inquiry, every question, every doubt, and every suspicion as probable reasons and get an answer to the same. The answer should always be supported with a valid document used to record the event supporting the investigation and can be considered as evidence. A hypothesis to figure out the underlying reason for such an event may be derived to demonstrate the sequence of events resulting in the discrepancy. Investigations can also be triggered by any of the investigators based on suspicious or a lead/information from any individual on a quality-related issue. An issue/event/activity / visual can be brought under the scope of investigation if found to be suspicious with a potential to harm the quality of the product.
5.1 Selection of Investigation Team Members:
5.1.1 An investigation team shall be formed based on the issue to be discussed and investigated. The team members may be added as the investigation progresses or as needed.
5.1.2 The investigation team shall include members from the originating departments and the relevant area of activity to begin with.
5.1.3 Investigation team member shall be formed based on their experience, skills, area of expertise, etc.
5.1.4 This list shall be prepared by the originating department Head and approved by the Head of Site Quality Assurance.
5.2 Investigation Methodology:
5.2.1 Investigation includes the following steps
1. Step I-Initiation of investigation
2. Step II-Collection of Data
3. Step III-Identification of possible factor (Root cause analysis)
4. Step IV-Summary of Investigation
A) Fishbone or Ishikawa or Cause-and-Effect Diagrams:
Ishikawa diagrams are also called Fishbone Diagrams, Cause and Effect Diagrams. The various possible causes are grouped into categories such as Men, Machines, Methods, Milieu (environment), Materials, and Measurements and the arrows indicate how the cause cascades or flows towards non-conformity. The identified causes shall be discussed in detail to demonstrate the potentiality of not causing the failure by stepwise elimination process. The example given below is for guidance purposes, investigation team members may review additional parameters as per discrepancy.
B) Why-Why Analysis:
Whys: The investigator shall keep asking the question ’Why?’ for the non-conformance/suspect until the contributing factor underlying the problem can be identified.
Benefits of 5-Why:
1. Simplicity: It is to use and requires no advanced mathematics or tool.
2. Flexibility: it works well alone and when combined with other quality improvement and troubleshooting techniques.
3. Quick resolve: It helps to quickly separate symptoms from causes and identify the root cause of a problem.
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