Subject Matter Expert: When we
say SMEs means Subject matter experts then we believe that he knows very well
about respective subject. He can explain everything about respective area/
topic/ Machine or whenever anyone asked with him. During external audit like FDA,
MHRA, WHO, other regulatory agency or Internal audit the SME plays a major role
and protect his organization from unnecessary observation. SME clear the query
of auditor and explain the activity what the auditor wants to know. If SMEs is
not appropriate then auditor will assumed as untrained person are working here
and if he not found correct answer then give observations.
It is not necessary if any person having well technical knowledge in respective area then it is sure he or she can explain perfectly whenever auditor asked question about his subject. In that case it is required to train your SME according to method of audit. Train them how to behave with auditor, how to listen auditor’s question, what say and what should not say during inspection, when to be speak, when to be silent. These behaviors make a perfect SME. Below are some dos and Don’ts that should follow during inspection to Subject Matter Expert.
2-Keep smile on your face but not over smile.
3-Be confident but not overconfident.
4-Listen auditor’s question carefully.
5-Repeat every question that he asked. It will make confirmation what you understand.
6-Ask for explanation or interpretations of what you do not understand.
7-Answer all questions honestly.
8- For that question, you are not sure then say “I don’t know” or “I’ll get the answer for you”.
9-Avoid such phrases as “I think,” “Sometimes/often/usually,” “never,” and “next time”.
10-Avoid qualifiers, such as “typically,” “normally,” “generally,” and “usually”.
11-Stop speaking once the question is answered.
12-Control your temper, remain polite and professional.
13-Maintain eye contact.
14-Speak clearly for easy to understand.
2-Volunteer information.
3-Be scare.
4-Guess answers.
5-Attempt to answer “what if?” or hypothetical questions of auditor.
6-Argue or disagree with any inspector statement.
7-Philosophize, ramble or editorialize in front of auditor.
8-Point out deficiencies or errors.
9-Apologize for problems or comments made by auditor.
10-Feel the need to respond to every comment made by auditor.
11-Become defensive or evasive.
12-Look away, fidget or look nervous.
13-Enter into casual conversation during the audit i.e. speak in local language.
14-Look at your senior’s face when auditor asks any question.
15-Without auditor permission, try to give explanation in other area also.
Auditors are trained in such a way that they can dig the information from anyone. Sometime what happened, they ask question and SME give answer. After over the answer from SME, still auditor silent and look at SME consistently in such a way that they want to listen more. In that case SME think auditor is not satisfied from his/her answer and SME try to explain additional things beyond the answer which is actually not required at that time. These are the style of auditors to find out extra information from persons.
In this situation when auditor still looks at SME face then SME should also be silent and waiting for auditor next question.
Such type of training should be provided to SMEs to make them perfect during inspections. Also perform mock audit and interact with your Subject matter experts to make them confident during inspection.
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.