admin | 18-03-2018
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.
Based on the nature of failure an investigation team (expert from different department e.g. manufacturing, packaging, quality, engineering, R&D etc.) to identified the assignable root cause should be form so that each and every fact can be investigate and root cause can be fixed. Real fact can be missed out if single person will involve in the investigation.
2. Delayed Investigation
Delay in the investigation destroy the fact or clue and as a results right assignable root cause can not be identified so investigation must be started immediately once failure encountered. Once failure encountered then that area, machine etc. should be secure immediately same like crime scene so that fact can not be destroyed.
To prioritize the investigation there should be "TRIAGE" mechanism. Triage is a medical terminology which is used at Emergency or Trauma center to start the treatment of patient based on his/ her condition. 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 investigation person if interview is required of person then generally person ask the question; why you have not seen? why you have not stop machine? How badly you do your work which make person uncomfortable so avoid all these type of question during person interview. It is better keep the person on ease and avoid too much person during interview. Ask the question from person at the same site where failure happened so that he can explain better. Don't interrupt the person when he is telling 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 choose very carefully e.g. where only single or two factor involve in the failure then you can use simple question asking tool i.e. 5-why but if you feel that multiple factors are involve in failure then use 6M , fish bone 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 investigate all the facts. Without investigate the right fact right CAPA can not be proposed and failure can be encountered again.
6. Lack of proof/ evidence
Most common mistake which we generally made; We write the complete investigation report but whatever we write in investigation we failed to collect all those evidence which make the investigation very poor.
7. Human failure not investigate thoroughly
Its most common mistake. Most of the time we never investigate why mistake made by a trained person. Human failure should be investigate further to understand the actual root cause why trained person make mistake. Most common factor behind human failure is INADEQUATELY WRITTEN PROCEDURE/ METHOD To understand further Human error can be classified as define below;
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 affected batch. Impact of the failure should be 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 taken only one the same machine/ product/ process where failure encounter however CAPA not taken holistically across other machine/ process/ products etc. and again failure encountered on other area, machine etc. CAPA not inline with identified assignable root cause. So CAPA (Corrective Action & Preventive action) should be define holistically and effectiveness of CAPA should be check periodically after its implementation.
SO NOW TAKE CARE DURING ANY FAILURE INVESTIGATION.
GOOD MANUFACTURING PRACTICES