Help me Audit Senior Management

[curryassassin]

Dear Fellow Covers,

Tomorrow I have one hour in which to interview my CEO about the responsibilities of senior management, and I need your help to ensure I don't waste my time. A little background.

I work for a small (30 employees) org that offers specialist laboratory testing services to the pharmaceutical industry. We are not certified to ISO9000 (maybe I'll convince them one day) but we are certified to the relevant pharmaceutical regulations. We have over 40 clients on our books, with lots of repeat business and new enquiries from potential clients each week. Sales, profits, staff and facilities/equipment/services is expanding (80% on last year). On the audit schedule this year, is this month's audit of Organisation & Personnel. So what should I ask the CEO?

I know him really well. We go way back. As Quality Manager, I am very familiar with the audit process, CAPA status, staff training, SOP needs, sub-contracting and other responsibilities as defined in the regs. The one area of all the regs and ISO9000 that really stands out is the 'sufficient resources' phrase, and this is the area that I am most concerned about. Since we are so small, and we seem to win a lot of repeat business and new business, how should I assess how management 'fits' new business into an already packed schedule? How is growth managed? What is success?

What questions would you ask? Your help would be greatly appreciated.

[Stijloor]

Originally Posted by curryassassin

Dear Fellow Covers,

Tomorrow I have one hour in which to interview my CEO about the responsibilities of senior management, and I need your help to ensure I don't waste my time. A little background.

I work for a small (30 employees) org that offers specialist laboratory testing services to the pharmaceutical industry. We are not certified to ISO9000 (maybe I'll convince them one day) but we are certified to the relevant pharmaceutical regulations. We have over 40 clients on our books, with lots of repeat business and new enquiries from potential clients each week. Sales, profits, staff and facilities/equipment/services is expanding (80% on last year). On the audit schedule this year, is this month's audit of Organisation & Personnel. So what should I ask the CEO?

I know him really well. We go way back. As Quality Manager, I am very familiar with the audit process, CAPA status, staff training, SOP needs, sub-contracting and other responsibilities as defined in the regs. The one area of all the regs and ISO9000 that really stands out is the 'sufficient resources' phrase, and this is the area that I am most concerned about. Since we are so small, and we seem to win a lot of repeat business and new business, how should I assess how management 'fits' new business into an already packed schedule? How is growth managed? What is success?

What questions would you ask? Your help would be greatly appreciated.

Hello curryassassin,

I developed a tool to audit the Top Management "process." See attached.
It is ISO 9001:2000 "flavored", but you can change, edit, modify, etc., make it work for you.

Good luck when you interview the "Boss."

Stijloor.

[Sidney Vianna]

Check the following two papers from the ISO TC 176 APG:
How to audit top management processes & Auditing Quality Policy, Quality Objectives, and Management Review

Good luck, and remember, you are auditing the system, not the people.

[AndyN]

Oh, when I read the title, I thought you wanted me to book a flight (I'm available next week!).

My currybuddy - according to another post around here, http://elsmar.com/Forums/showthread.php?t=23232 you only have to spend 15 minutes and you can ask two questions.

However, I would prefer something a little more practical.

After the appropriate time spent studying current objectives, customer feedback, lab performance etc. I'd go and ask the following:-

How well are the lab's current business objectives being met? i.e are we on target with the KPI's. Then, if they are, what is planned on being improved (customer or business focus). If they aren't what's being done to correct it? Do you know if we get these results because everyone's following the lab qms? (audit results)

I believe this would be the basis of a pretty interesting conversation, especially since he should be able to pull all this info together fairly easily.

(p.s I can fly into LHR or Birmingham - would you be able to come pick me up to keep expenses low?)

[curryassassin]

Originally Posted by Stijloor

Hello curryassassin,

I developed a tool to audit the Top Management "process." See attached.
It is ISO 9001:2000 "flavored", but you can change, edit, modify, etc., make it work for you.

Good luck when you interview the "Boss."

Stijloor.

Thanks. Many of these questions may be brushed off as 'ISO9000 related - we don't want that management responsibiliy'. Also our company is very customer facing. A project plan is prepared and approved by the client for each project, the work is done, progress/problems/results are communicated to the client at the time or are included in the project report. It appears as if we know what they want???

[curryassassin]

Originally Posted by Sidney Vianna

Check the following two papers from the ISO TC 176 APG:
How to audit top management processes & Auditing Quality Policy, Quality Objectives, and Management Review

Good luck, and remember, you are auditing the system, not the people.

No quality policy, quality objectives or management review.

[curryassassin]

Originally Posted by AndyN

Oh, when I read the title, I thought you wanted me to book a flight (I'm available next week!).

My currybuddy - according to another post around here, http://elsmar.com/Forums/showthread.php?t=23232 you only have to spend 15 minutes and you can ask two questions.

However, I would prefer something a little more practical.

After the appropriate time spent studying current objectives, customer feedback, lab performance etc. I'd go and ask the following:-

How well are the lab's current business objectives being met? i.e are we on target with the KPI's. Then, if they are, what is planned on being improved (customer or business focus). If they aren't what's being done to correct it? Do you know if we get these results because everyone's following the lab qms? (audit results)

I believe this would be the basis of a pretty interesting conversation, especially since he should be able to pull all this info together fairly easily.

(p.s I can fly into LHR or Birmingham - would you be able to come pick me up to keep expenses low?)

Thanks, mate, you did make me chuckle. I'd love you to come, but fear my CEO may offer you my job !!!

We don't have objectives or KPIs. I should also point out our regulatory inspections threw up only minor comments as have several recent client audits.

[AndyN]

Originally Posted by curryassassin

Thanks, mate, you did make me chuckle. I'd love you to come, but fear my CEO may offer you my job !!!

We don't have objectives or KPIs. I should also point out our regulatory inspections threw up only minor comments as have several recent client audits.

Really - like really???? Your top bloke doesn't have something in mind for how he determines if the lab's been having a good year? If not, then don't waste your time with the audit, use the time to coach him as to the strategic advantage of having a defined qms to manage risk - capitalize, if you like on the 'good' of what's been happening, so that - as the lab gets more work - the ball won't be dropped, a customer unhappy and the resulting losses of revenue, face etc. Or use the looming risk of a regulatory issue causing significant losses (as before) up to and including someone's life. He's probably thought of this at some time, if not wracked by the fear on a regular basis.

If he isn't, and doesn't want to discuss it with you - start looking at Monster.co.uk............