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Moh1975
Please elaborate in detail on how to identify, develop and sustain Subject Matter Experts in different departments for audit as well as knowledge sharing aspects?
From India, Chennai
Dinesh Divekar
7855

Dear Moh1975,

You could have given information about the nature of your industry, the type of workforce your company has and above all, your designation and why the query is being raised.

The HOD of each department generally spends a sufficiently long time in their respective function and is expected to be a Subject Matter Expert (SME). They develop their functional expertise because of their long stay in the department. When they started their career the dynamics of the industry was different, however, as they progressed in their career, they saw a lot of changes. Additionally, they also get exposure to the various acts, laws related to their function. They also deal with the various government authorities. HODs are expected to be advisers to the management for the area related to their work.

Your query is on the "audit" of the department. What kind of this audit is and who will do it? Will it be an external party or an internal one? What kind of knowledge sharing is expected?

Please give a little more clarification.

Thanks,

Dinesh Divekar

From India, Bangalore
Moh1975
Dear Mr.Dinesh Divekar,

Thanks for your timely insights.

Regarding your details-finding exercise, I would like to furnish the below information.

I basically belong to Pharma Industry as Sr.Mgr.
We are facing scheduled ISO/GMP/Regulatory Inspections/Self-Inspections etc.
This involves both internal and external people.

For training our dept.staff, cross-functional staff and to explain the processes to auditors, we need a procedure to establish SMEs.

The query is raised for the above objectives.

Thanks in advance for throwing light on this topic.

Regards,
Mohan.

From India, Chennai
Dinesh Divekar
7855

Dear Mohan,

If your company is aware of the audits that will take place at regular intervals, then you may organise a brainstorming session for all HODs and Managers to prepare the SOP for each type of audit. The SOP should have details like"

a) Chalk an audit calendar for the next 2-3 years.
b) What is to be done, who will do it, when they will do it, how they will do it
c) Identify the auditable documents and other records. Which are the common documents or records that will be audited across all types of audits? Can a specific audit (like ISO) be given primacy?
d) Identifying the ownership of the auditable documents and also handing/taking over of the auditable documents in case of HOD's long leave or separation from the company
e) How to avoid a last-minute hustle and bustle on receipt of the intimation on the external audit?
f) What checks senior management or top management personnel will do to ensure that audits are not seen as a clumsy activity.
f) How to record post-audit lessons in an organised manner?

Additionally, you may include a chapter on "Audits", in the induction manual also.

Thanks,

Dinesh Divekar

From India, Bangalore
Moh1975
Thanks a lot for giving detailed perspectives on the Subject Matter, Sir.
From India, Chennai
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