How to Determine Mandays for Different Plants?

Ajit Basrur

Staff member
Admin
#1
I have a question - we have 14 plants differing in size and volumes that they handle. Even the product range is different from sterile to non sterile pharmaceuticals.

As part of the Internal audit for non steriles, we have fixed 3 auditors who audit for 5 working days thus totalling 15 mandays and for sterile areas, it is 4 auditors and 5 working days totalling 20 mandays. Sometimes, if the audit scope gets extended, we assign one more auditor.

This entire exercise is working well but I am open to ideas on how to quantify the mandays for internal audits based on different inputs. Is there any MS Excel apreadsheet on this quantification ?

Thanks in advance :thanx:
 
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Randy

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#2
Ajit, I have seen folks apply the same formula from the IAF that the CB's are required to use. It works for them, takes out the guesswork and can easily be justified.
 
#3
I'd be inclined to do it empirically. Have one of your better (more competent) auditors do an audit, observe them and time them. You could add some time for less experienced auditors etc (maybe 25%) and use that on a 'per process' basis as a multiplier. See how it goes, make adjustments and so on. No fun, not 'scientific' but probably as good as it gets. Not sure about the CB guidelines - they're for very experienced based on number of heads, not complexity of processes etc.
 

Sidney Vianna

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#4
Not sure about the CB guidelines - they're for very experienced based on number of heads, not complexity of processes etc.
Andy, keep in mind that the process for estimation of audit days, according to the IAF MD5 (as well as the previous IAF Guide to ISO GD62) does take into account many issues, including number of processes and system complexity. The number of employees is just the starting point for the determination, as indicated in the MD5 chart below.
 
#5
Andy, keep in mind that the process for estimation of audit days, according to the IAF MD5 (as well as the previous IAF Guide to ISO GD62) does take into account many issues, including number of processes and system complexity. The number of employees is just the starting point for the determination, as indicated in the MD5 chart below.
True, Sidney, however, I didn't want to complicate the matter!

I wasn't attempting to demonstrate my entire knowledge of the ins and outs of adjustments which we as CBs are allowed, since this seemed to be for manufacturing processes and not, for example, design, purchasing, training etc.

Specifically, this is an internal audit and I don't believe that working out an audit duration based on 'heads' is appropriate!
 

Sidney Vianna

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#7
Specifically, this is an internal audit and I don't believe that working out an audit duration based on 'heads' is appropriate!
I will respectfully differ with your view point. Number of employees is an important factor for the determination of audit duration, be it 1[sup]st[/sup] or 3[sup]rd[/sup] party audits. Simply because the sample audited must be representative of the "population". So, a larger headcount should be followed by a larger sample, in order to ensure that the auditor is reaching decisions, based on a statistically valid sample size.
 
#8
Simply because the sample audited must be representative of the "population". So, a larger headcount should be followed by a larger sample, in order to ensure that the auditor is reaching decisions, based on a statistically valid sample size.
Why? Could you explain the rationale for the population of a process having an impact on the duration of an internal audit?
 

Jim Wynne

Staff member
Admin
#9
Why? Could you explain the rationale for the population of a process having an impact on the duration of an internal audit?
A process that has 12 consecutive operations, each with two or three people and each with its own documentation should take the same amount of time to audit as a process with one operation, one operator and one document?
 

Sidney Vianna

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#10
Make Jim's my words...:tg:
Why? Could you explain the rationale for the population of a process having an impact on the duration of an internal audit?
A process that has 12 consecutive operations, each with two or three people and each with its own documentation should take the same amount of time to audit as a process with one operation, one operator and one document?

You doing an internal audit of Boeing's Everett plant with 18,000+ employees. Are you going to spend the same 1/2 day as you would be spending at Radio The Shack store, at the corner?
 
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