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.

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.

Check the following two papers from the ISO TC 176 APG:
How to audit top management processes (http://isotc.iso.org/livelink/livelink/3553985/APG-AuditTopManagement.doc?func=doc.Fetch&nodeid=3553985) & Auditing Quality Policy, Quality Objectives, and Management Review (http://isotc.iso.org/livelink/livelink/3553587/APG-QualityPolicyandObjectives.doc?func=doc.Fetch&nodeid=3553587)

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

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?):lmao:

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???

Check the following two papers from the ISO TC 176 APG:
How to audit top management processes (http://isotc.iso.org/livelink/livelink/3553985/APG-AuditTopManagement.doc?func=doc.Fetch&nodeid=3553985) & Auditing Quality Policy, Quality Objectives, and Management Review (http://isotc.iso.org/livelink/livelink/3553587/APG-QualityPolicyandObjectives.doc?func=doc.Fetch&nodeid=3553587)

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

No quality policy, quality objectives or management review.

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?):lmao:

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.

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............

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???

Feel free to "de-isoize" this list. (A new word I cooked up; meaning remove the "ISO flavor"). Audit from a customer perspective. To be honest with you, that's the intent of the quality system for which you Top person is responsible anyway.

Stijloor.

No quality policy, quality objectives or management review.

You may not have them formally defined, but if you look beyond formality, is there no evidence of a system that is customer focused, knowledge of what the expectations are, or regular interactions between Managers?

Stijloor.

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............

He is a great bloke - maybe too nice and too optimistic. He is pretty hands on. As an academic he loves to help out in any area, which the board and some clients have identified as a problem - does he want to be CEO or 'Scientific Director'.

I would say objectives would be, according to the business plan, increase in sales, profit, growth, fewer failed test runs, fewer record errors, but also that the company is adding value from a scientific perspective ie providing testing services that produce meaningful data to help get new durgs on the market quicker. Not sure this can be measured. I plan to ask him what the objectives for the company are and how and when these will be identified and communicated, measured, improved upon.

He is a great bloke - maybe too nice and too optimistic. He is pretty hands on. As an academic he loves to help out in any area, which the board and some clients have identified as a problem - does he want to be CEO or 'Scientific Director'.

I would say objectives would be, according to the business plan, increase in sales, profit, growth, fewer failed test runs, fewer record errors, but also that the company is adding value from a scientific perspective ie providing testing services that produce meaningful data to help get new durgs on the market quicker. Not sure this can be measured. I plan to ask him what the objectives for the company are and how and when these will be identified and communicated, measured, improved upon.

Nice one, Curry! (or is that Cyril?)

Nice one, Curry! (or is that Cyril?)

:topic: You're not a Spurs fan are you?

:topic: You're not a Spurs fan are you?

Not me! I prefer the Hooligan's game played by Gentlemen.........:cool:

Not me! I prefer the Hooligan's game played by Gentlemen.........:cool:

No, gentlemen didn't wear pads and lift at the lineout when I played.....

No, gentlemen didn't wear pads and lift at the lineout when I played.....

Me either............:lol:

Keep it simple guys so the poor chap doesn't confuse those people any more than they might be due to their lofty position and the rarified air up there.

Simply put, Senior (top) management responsibilities are very clearly defined and in part consist of ...in no specific order....

1) authorize and have put into place a policy that clearly states how the organization intends to achieve customer satisfaction while seeking ways to improve the way it does so.

2) clearly define and have made known to all persons in the organization the individual role they must meet in helping the organization fulfill its commitments in the policy

3) specifically identify and assign an individual(s) working at some level of understood leadership within the organization the responsibility to specifically manage the process of putting the system in place according to its requirements and then reporting back to them the status of the system at periods and times that they dictate.

4) provide the resources whether its money, people, time, equipment, materials, training, assistance, or whatever else is identified as necessary to achieve the satisfaction of the customer and achievement of objectives, sustain the capabilities of the organization to do so and allow for improvement when deemed necessary

5) perform reviews of the performance of the management system on a timely basis and of the presribed information in the standard.

6) make decisions based on information from the review process for the improvement of the system, changing the policy to more accurately reflect the intent of the organization, determination and allocation of any new resource needs, product improvements

7) approve of objectives for the organization to achieve

8) provide focus on customer needs and satisfaction

9) free up and provide the tools to allow for the communication of relevant information across the organization

All the other hocus pocus stuff is eyewash, fluff and clumsy to use...keep it simple and relevant to the process which is your QMS

Hey, Good Luck!

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.

[this is so helpfull thanks and more information keep it coming]

[this is so helpfull thanks and more information keep it coming]

Thank you for your kind comment.

Welcome to The Cove Forums! :bigwave: :bigwave:
Please come back for sharing and learning...:agree1:

Stijloor.