Definitely you have encountered anytime with failure and you have done the investigation. If you see the FDA 483 and MHRA observation then you will find most of the observations are related to anomalous of investigation. I hope this article will help you to understand that what type of common mistakes we made during any failure investigation.

1. Investigate individually rather than as a team; 

Based on the nature of failure an investigation team (expert from different department e.g. manufacturing, packaging, quality, engineering, R&D, etc.) to identify the assignable root cause should be formed so that each and every fact can be investigated and root cause can be fixed. The real fact can be missed out if a single person will involve in the investigation.


2. Delayed Investigation

Delay in the investigation destroy the fact or clue and as a result right assignable root cause can not be identified so investigation must be started immediately once failure encountered. Once failure encountered than that area, machine, etc. should be secure immediately the same as the crime scene so that fact can not be destroyed. Dealy in the investigation – Destruction of fact or clue which makes the investigation more difficult. In the investigation procedure deadline for the investigation completion should be defined and any delay in the investigation completion should be justified and interim control should be available to safeguard the product in that case.

To prioritize the investigation there should be a “TRIAGE” mechanism. Triage is a medical terminology that is used at the Emergency or Trauma center to start the treatment of the patient based on his/ her condition. A similar investigation should be started based on the criticality of any failure so that its impact can be minimized timely.

3. Blame Game culture

During the investigation, if an interview is required of a person then generally person asks the question; why you have not seen? why you have not to stop the machine? How badly you do your work which makes the person uncomfortable so avoid all these types of questions during personal interviews. It is better to keep the person at ease and avoid too many people during the interview. Ask the question from a person at the same site where the failure happened so that he can explain better. Don’t interrupt the person when he is telling a complete story. Just record the whole story and try to connect all the dots…

4. Selection of wrong investigation tools

There are different tools to investigate the failure like; 5-why, FTA (Fault tree analysis), FMEA, 6M (Men, Machine, Material, Method, Measurement & Mother’s nature). Investigation tool should be chosen very carefully e.g. where only single or two factors involved in the failure then you can use simple question asking tool i.e. 5-why but if you feel that multiple factors are involved in failure then use 6M, fishbone or FTA tools to identify the assignable root cause.

5. Directly jump on conclusion

Don’t try to hide the actual fact. Don’t jump directly on the conclusion without investigating all the facts. Without investigating the right fact right CAPA can not be proposed and failure can be encountered again.

6. Lack of proof/ evidence

The most common mistake which we generally made; We write the complete investigation report but whatever we write in the investigation we failed to collect all those evidence which makes the investigation very poor.

7. Human failure did not investigate thoroughly 

Its the most common mistake. Most of the time we never investigate why mistakes made by a trained person. Human failure should be investigated further to understand the actual root cause of why trained people make a mistake. The most common factor behind human failure is INADEQUATELY WRITTEN PROCEDURE/ METHOD  To understand further Human error can be classified as define below;

Human Error Categorization
Human Error Categorization

                                                                     8. Inadequate Impact assessment

During investigation people generally fail to do the right impact assessment considering the following impact on safety, efficacy, potency, quality of the affected batch. The impact of the failure should be a check on current products/ batch or previously produce products/ batches and action should be define based on that assessment.

9. Failure to proposed right CAPA (Corrective Action & Preventive Action)

CAPA has taken only one the same machine/ product/ process where failure encounters however CAPA not taken holistically across other machines/processes/ products etc. and again failure encountered on other areas, machine, etc. CAPA not inline with identified assignable root cause. So CAPA (Corrective Action & Preventive action) should be defined holistically and the effectiveness of CAPA should be check periodically after its implementation.

                                  SO NOW TAKE CARE DURING ANY FAILURE INVESTIGATION.