Why investigation is required for Market Complaint Deviation and Incidents.
Inorder to identify the root cause, it is required to conduct a investigation and root cause analysis, it can be done through Investigation which intern adapts various techniques of identification of root cause.
Following are tools which one can use to Identify root cause.
1.Ishikawa Fish Bone diagram Analysis.
As per diagram illustrating the heading of investigation like, personnel, material, Measurements, machine, method, and environment. Points should be discussed to identify any untoward observation.
2.Why Why Analysis.
Make a list of questions to the point and try to get unbiased answers for same.
3. Brainstorming
4. Reconstruction of the event.
5. Experimentation.
Ishikawa Fish Bone diagram
Interviews of personal involved and discussion is also helpful.
An Investigator must not have prejudice or biases on the subject.
Is it required to investigate a deviation?
Yes repitative deviations should have an Investigation and root cause analysis and CAPA so that they don't occur in future.
If a deviation is unplanned, it is also classified as incidance, all unplanned deviations must have root cause analysis and identify the root cause and CAPA so that they don't occur in future.
It's important first to classify the complainant is a genuine or a fake.
Many times compititors file false market complaint to Pharmaceutical regulatory agencies FDA, as well as to Quality Department of the company.
It's important to get the sample of the complainant, and observe the same. Many times observations on the sample reveille the fact that it was tampered. Such instances it's required to conduct unbiased Investigation.
Why Why Analysis and Brainstorming sessions are very effective as Investigation tools lateron the data gathered can be ustilsed with Ishikawa Fish Bone diagram.
If a market complaint sample has any untoward observation that must be reproduced in laboratory by experimentation reconstruction of the events.
Incase of an Incidence reconstruction of events gives clue for the root cause.
By adapting above discribed methodology a root cause must be identified from the root cause analysis and a proper Corrective and Preventive Action can be proposed and implemented.
Even if after the implementation of such Preventive Actions if any incidance happens or same market complaint is reported one should follow same investigation methodology by changing the investigator.
Most of the time unbiased Why Why Analysis is very useful in getting actual root cause of any incidance or market complaint.
Alternatively Root cause analysis technical team can be formed taking in one individual from every section. Like Quality Assurance. Production, Quality Control. R & D.
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