Unusual requests from some auditees? bosses

LesPiles

Involved In Discussions
#1
Hello everyone!

We’ve just made a late audit a fews fays ago, and when planning audit, we have faced some difficulties. We have informed that we would do an audit and thereafter, we made requests to visit some people.

In the R & D department, we were faced with the reaction of the manager who wanted:
• to be informed of the resources of his department who would be interviewed
• to nominate himself those persons to be interviewed for those processes to be audited, and finally,
• To be present during these audits.

Given already difficult context to conduct the audit this year (we faced a tight schedule), we were "good prince" by acquiescing to his points - although we did not agree in principle. But hey! We do not have much to hide ;) - unlike him, maybe? ;)

I have though included in my report remarks about the behavior of this manager which is unusual (it's the first time I encounter this case in several years of practice). I have also talked to my boss and he also does not agree with this approach ... that could be described as equivalent to putting "the dust under the carpet" while an audit goal is about the opposite !

The purpose of my post is to receive your comments regarding this "incident".

In addition, I would also receive your comments about "who" should put this manager "in the right track" ...

Greetings


Les Piles
 
Elsmar Forum Sponsor
#2
Les Piles:

In my experience, what you described is a function of the way many people do audits - based on what they were taught in a Lead Auditor or similar course - and that model is an external audit! That model is wrong for internal audits (but no-one seems to understand how wrong).

The fact is that, since audits are often done on the external model, there is an external influence at play - audits on suppliers are done by customers - so you'd better take notice or risk losing their business! When done by CB auditors it becomes, you'd better take notice or risk losing our certificate.

The audits MUST go ahead or there's a risk - and who wants to be responsible for THAT?

Internal auditors don't have either of those drivers to fall back on - who cares?

So, the way in which internal audits are planned and focused must be different. You HAVE to engage management before hand, to ensure that the audit focuses on something they will get some help with. Of course there will always be those difficult people who won't get it, but their boss(es) will - and you might have to work a little harder to win some friends, but it will happen...
 
P

PaulJSmith

#3
Re: Unusual requests from some auditees’ bosses

I suppose the key to understanding his behavior is knowing what drives it. As Andy suggested, it may be previous experience with auditors has him apprehensive about your process. If that's the case, a closer look at that may be in order.

It may also be that he's just an overbearing jerk who's looking to protect his reign over his little kingdom. If that's the case, he needs to be brought into the fold with the rest of the company. He needs to understand the true purpose of internal audits. Surely he answers to someone. That might be a good place for your manager to start.
 

Ninja

Looking for Reality
Trusted Information Resource
#4
Re: Unusual requests from some auditees’ bosses

Some great feedback so far, so I thought I would chime in in counterpoint.

It may be that the R&D manager wants to learn...I did.

When manufacturing was being audited, and I had just made a significant change to how one group operated, I wanted to be consulted re: who got audited so that I could make sure that group was on the list.
All the same, I stated to the audit team that that was why...not just a blanket "Let me pick".

When a relatively new employee is selected for audit, I want to be present. I don't want to steer the audit, but I do want to know where I haven't done a good enough job. The wrap up meeting will identify some of those weaknesses...but if I watch it happen I'll get to see all of them. Then I know where to fill in the gaps so the next audit goes much better (or more to the point so the employee does not suffer from my oversight).
I can provide better coaching after the audit if I see the details of what went on rather than an audit summary.

An audit team does their job...but a manager should know more about what's behind the weakness (if any) and can get a really good view from watching (not participating in) the audit and know where to strengthen things/people/systems.

The group manager who works for me has never been in the lead for an audit (being audited). He has tagged along twice while I was the primary person being audited. Next audit, he will be in the lead...but I'll be there.
All things going well, I won't be there for the following one since I won't be needed.

It may be that the R&D leader is a control freak...it may be that he's trying to do his job better...the "WHY" of his requests are important to know in order to discern between these.
:2cents:
 

Mikishots

Trusted Information Resource
#5
Re: Unusual requests from some auditees’ bosses

Hello everyone!

We’ve just made a late audit a fews fays ago, and when planning audit, we have faced some difficulties. We have informed that we would do an audit and thereafter, we made requests to visit some people.

In the R & D department, we were faced with the reaction of the manager who wanted:
• to be informed of the resources of his department who would be interviewed
• to nominate himself those persons to be interviewed for those processes to be audited, and finally,
• To be present during these audits.

Given already difficult context to conduct the audit this year (we faced a tight schedule), we were "good prince" by acquiescing to his points - although we did not agree in principle. But hey! We do not have much to hide ;) - unlike him, maybe? ;)

I have though included in my report remarks about the behavior of this manager which is unusual (it's the first time I encounter this case in several years of practice). I have also talked to my boss and he also does not agree with this approach ... that could be described as equivalent to putting "the dust under the carpet" while an audit goal is about the opposite !

The purpose of my post is to receive your comments regarding this "incident".

In addition, I would also receive your comments about "who" should put this manager "in the right track" ...

Greetings


Les Piles

I don't see it as an issue, because you will be asking the questions you need to ask, and you will be expecting answers . If the staff that the manager nominates cannot provide you with the information you need, then you have not seen the required evidence to show effectivity; you have your findings.

The nominated people can be hand picked and can talk all they want. Your job is to say "Hey, that sounds really good! Show me." If the process is in place and is functioning as intended, it makes no difference who that manager nominates.

My approach would be: "I will be speaking to engineering staff as required by the audit trail. I am looking for evidence of effectiveness of the process, and you are free to nominate or provide any staff member you see fit in order to demonstrate that effectivity. If you cannot demonstrate that effectivity to me, findings will be assigned in order to correct it."
 

Helmut Jilling

Auditor / Consultant
#6
Some great feedback so far, so I thought I would chime in in counterpoint.

It may be that the R&D manager wants to learn...I did.

When manufacturing was being audited, and I had just made a significant change to how one group operated, I wanted to be consulted re: who got audited so that I could make sure that group was on the list.
All the same, I stated to the audit team that that was why...not just a blanket "Let me pick".

When a relatively new employee is selected for audit, I want to be present. I don't want to steer the audit, but I do want to know where I haven't done a good enough job. The wrap up meeting will identify some of those weaknesses...but if I watch it happen I'll get to see all of them. Then I know where to fill in the gaps so the next audit goes much better (or more to the point so the employee does not suffer from my oversight).
I can provide better coaching after the audit if I see the details of what went on rather than an audit summary.

An audit team does their job...but a manager should know more about what's behind the weakness (if any) and can get a really good view from watching (not participating in) the audit and know where to strengthen things/people/systems.

The group manager who works for me has never been in the lead for an audit (being audited). He has tagged along twice while I was the primary person being audited. Next audit, he will be in the lead...but I'll be there.
All things going well, I won't be there for the following one since I won't be needed.

It may be that the R&D leader is a control freak...it may be that he's trying to do his job better...the "WHY" of his requests are important to know in order to discern between these.
:2cents:
In my CB audits, managers are welcome to participate or watch. I encourage them to do so, most of the time. However, I would be very uncomfortable if they appear to be cherry-picking whom I may speak with...if I get a sense they are trying to control the audit, I may intervene.

If I perform internal audits, the rules are more flexible. We encourage manager participation, and usually get it. But, we can work around managers who try to control things too much.
 

Big Jim

Super Moderator
#7
Internal audits or CB audits, one of the topics I cover in the opening meeting is that I, the auditor, needs to keep control of the audit sampling. Sometimes I let them pick the first sample (and often it ends up being the one with a problem even though they thought they were cherry picking), but I take control from there. If they resist, I remind them that as I told them in the opening meeting, the auditor needs to have control of the audit samples. I've never had trouble with this approach.
 

normzone

Trusted Information Resource
#8
My previous boss used to try to answer the questions and guide the auditee when things were going astray, and I've seen the external auditor tell my boss to get lost, he wanted to talk to the auditee. Funny to watch. My previous boss was a sales guy at heart, so his instincts overcame his QA training.
 

somashekar

Staff member
Super Moderator
#9
In the R & D department, we were faced with the reaction of the manager who wanted:
• to be informed of the resources of his department who would be interviewed [ The audit can begin with the manager first, who would then direct himself to the resources of his department who would be interviewed based upon the process / activity audited ]
• to nominate himself those persons to be interviewed for those processes to be audited, [ By all means, as said above. Ensure roles and responsibilities that are defined for those persons match to the audited process ] and finally,
• To be present during these audits. [ Most welcome, if the presence is not an intervention, but just the timely support to assist the auditee when really necessary. The auditor must be able to judge this, rather than get swayed away by the manager ]
 
Thread starter Similar threads Forum Replies Date
Ron Rompen Unusual problem with Excel - Need some help Excel .xls Spreadsheet Templates and Tools 7
J Capability Analysis - Unusual Statistical Distribution of my Proccess Capability, Accuracy and Stability - Processes, Machines, etc. 5
S Have you seen and What is an Unusual Controlled Document Records and Data - Quality, Legal and Other Evidence 6
Ron Rompen Shiftwork Scheduling - An unusual problem - Need help please Human Factors and Ergonomics in Engineering 13
Chennaiite "Unusual Situation" in Gemba? Just Food for thought Quality Manager and Management Related Issues 0
Ron Rompen Unusual GD&T Callout similar to the MMC or LMC symbol Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Nissan asks about an Unusual Situations procedure IATF 16949 - Automotive Quality Systems Standard 5
B Service and maintenance company - I have an unusual exclusion to talk about in 7.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
P QMS Process Map - Comments on my unusual QMS process map Process Maps, Process Mapping and Turtle Diagrams 5
M Part Time Quality - Am I the only one? Is Part Time Quality unusual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Unusual ('Weird') Standards -'Bouncers' get their own standard Various Other Specifications, Standards, and related Requirements 5
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 2
P Customer Corrective Action Requests in OASIS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Advice needed - Environmental MS - unwritten but customer requests policy document ISO 14001:2015 Specific Discussions 5
Q Tips for Action Requests on Communication and Leadership ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
M Informational The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants a Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
C If it's not a custom-made medical device... What is it? Clinician requests EU Medical Device Regulations 11
T EU Regulation 207/2012 - EIFU - Customer Requests EU Medical Device Regulations 1
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
S Auditor requests confidential information via Email ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
L Handling Sort/Return Requests Customer Complaints 8
P Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis Nonconformance and Corrective Action 2
S Handling Cost of Sales requests for Customer Quality Manager and Management Related Issues 2
T Process Matrix for ISO 9001 - SRI requests R.20 44KO Sample/Example ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
MarilynJ6354 Missing Corrective Actions - Workforce does not trigger corrective action requests General Auditing Discussions 6
5 Expediting Internal Corrective Action Requests (CAR) Closures Nonconformance and Corrective Action 3
J ISO 17025, Laboratory Scope and Certifications Requests ISO 17025 related Discussions 4
K Suppliers not responding to Supplier Corrective Action Requests (SCAR) Supplier Quality Assurance and other Supplier Issues 12
T Customer and Supplier Information - Requests and Questionaires Customer and Company Specific Requirements 2
R 510(k) Statement Requests to a Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
I Manufacturing build requests - process and form Other Medical Device Regulations World-Wide 4
x-files Proper Document Control Requests Document Control Systems, Procedures, Forms and Templates 1
S Customer Corrective Action requests and Sales Employees Promises AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Why the FDA requests Lot Number in Testing Reports 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M Concession Requests from Suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Customer Requests On-site Audit Supplier Quality Assurance and other Supplier Issues 9
pittmatj CFDA Requests Biocompatibility Evaluation for Raw Materials ISO 13485:2016 - Medical Device Quality Management Systems 6
D Combining Internal & External Corrective Action Requests Nonconformance and Corrective Action 5
x-files Plans/Requests from Parent Company: Objectives or still plans? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Requirements vs. Change Requests - IEC 62304 Definitions IEC 62304 - Medical Device Software Life Cycle Processes 4
S Whose responsibility is it to issue Corrective Action Requests? Internal Auditing 8
L How to deal with too many CARs (Corrective Action Requests), PARs (Preventive Action) Nonconformance and Corrective Action 25
K Looking for Ideas to Track Customer Requests and PPAP Data Packages APQP and PPAP 4
Mr.Happy Operator Mistakes (Errors) and responding to CAR (Corrective Action Requests) Nonconformance and Corrective Action 20
Ajit Basrur FDA Guidance Document - User Fees for 513(g) Requests US Food and Drug Administration (FDA) 3
A Closing CARs (Corrective Action Requests) due to Process Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R PPAP requests for old parts that pre-date your PPAP Process APQP and PPAP 2
M Formula for Prioritizing Engineering Change Requests (ECR)? Document Control Systems, Procedures, Forms and Templates 1

Similar threads

Top Bottom