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
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From India, Chennai
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Dear Moh1975,
You could have provided 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 Head of Department (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 were different; however, as they progressed in their career, they saw a lot of changes. Additionally, they also get exposure to the various acts and laws related to their function. They also deal with 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 audit is this, and who will conduct it? Will it be an external party or an internal one? What kind of knowledge sharing is expected?
Please provide a little more clarification.
Thanks,
Dinesh Divekar
From India, Bangalore
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8219You could have provided 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 Head of Department (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 were different; however, as they progressed in their career, they saw a lot of changes. Additionally, they also get exposure to the various acts and laws related to their function. They also deal with 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 audit is this, and who will conduct it? Will it be an external party or an internal one? What kind of knowledge sharing is expected?
Please provide a little more clarification.
Thanks,
Dinesh Divekar
From India, Bangalore
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Dear Mr. Dinesh Divekar,
Thank you for your timely insights.
Regarding your details-finding exercise, I would like to provide the following information.
I basically belong to the Pharma Industry as a Senior Manager. We are currently facing scheduled ISO/GMP/Regulatory Inspections, Self-Inspections, etc., involving both internal and external stakeholders.
To train our department staff, cross-functional teams, and explain processes to auditors, we require a procedure to establish Subject Matter Experts (SMEs).
The query is raised to achieve the above objectives.
Thank you in advance for shedding light on this topic.
Regards,
Mohan
From India, Chennai
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Thank you for your timely insights.
Regarding your details-finding exercise, I would like to provide the following information.
I basically belong to the Pharma Industry as a Senior Manager. We are currently facing scheduled ISO/GMP/Regulatory Inspections, Self-Inspections, etc., involving both internal and external stakeholders.
To train our department staff, cross-functional teams, and explain processes to auditors, we require a procedure to establish Subject Matter Experts (SMEs).
The query is raised to achieve the above objectives.
Thank you in advance for shedding light on this topic.
Regards,
Mohan
From India, Chennai
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Dear Mohan,
If your company is aware of the audits that will take place at regular intervals, then you may organize 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 organized manner?
Additionally, you may include a chapter on "Audits" in the induction manual also.
Thanks,
Dinesh Divekar
From India, Bangalore
Acknowledge(0)Amend(0)
If your company is aware of the audits that will take place at regular intervals, then you may organize 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 organized manner?
Additionally, you may include a chapter on "Audits" in the induction manual also.
Thanks,
Dinesh Divekar
From India, Bangalore
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