Soft Side of Internal Auditing

D

Deepu

#1
I happen to be the MR in my organization. During one of our last internal audits, one of my internal auditors was checking the QMS awareness of a new joinee in a support department. For some reason the auditee became very apprehensive and was almost shivering when she was asked questions. Lo, the Department Head complained to the CEO that the internal auditing team was not taking people's feelings into consideration. Result - the CEO gives me an action to train my internal auditors on the soft side of internal auditing. My auditor is not all that bad, though he has a habit of asking 'trick' questions to check awareness.

I am stuck and don't have sufficient matter for a half an hour to one hour session. :(Well I can say that an auditor needs to be on a fact finding and not fault finding mission, one needs to put the auditee at ease by some general chit chat in the beginning, etc, etc. But I feel I am missing something. Can anyone in the forum give me some guidance to prepare a presentation with some punch on this subject? Is there information that will be useful in this context available in the net or in any of the previous threads? My search results were not satisfactory. Maybe someone even has a ready made presentation on this subject (being overly optimistic). Thanks in advance for your help.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
There are people who are difficult to audit in the way some people do not do well taking tests. To some people it can be emotionally tramatic. I have seen people cry in audits. In one 5000+ facility I worked with during their imlementation 2 women went to the hospital (one fainted and the other became what might be described as a nervous wreck).

The biggest factor I found in reducing the problem is making sure everyone has some type of basic training in how to handle an auditor - What questions to expect and how to answer. I know I have some stuff here. I'll have to ferret it out. I also made wallet cards with the Quality Policy and things the auditors might ask them.

Since as far back as 1994 I convinced a number of companies to have t-shirts printed up with something like the company logo on the front and in big letters " I'm Ready! Audit me!" on the back. We had everyone in the company wearing them for at least the first day. Talk about getting employees energized and ready for an auditor...

Now - I realize I'm referring to registration audits, but even in internal audits there are going to be people who have a hard time. For some of them there is nothing you can do about it. An audit is like a test. Some people do very well while other 'freeze up' or otherwise have problems.

Just some thoughts...
 
P

Phiobi

#3
You could suggest, to your CEO, that the only way to avoid this sittuation in the future is to use an automated software program to assess the ongoing level of awareness and effectiveness of your fellow employee's. That way you avoid trick questions and people can be assessed by email, therefore take away the one on one stress that some people just cannot handle.

There are companies out there that will provide the skills and software to perform such tasks, it can even be used to assess QMS effectiveness AND is now being used by a CB!!
 
Last edited by a moderator:
J

JaneB

#4
Gee, one single person was apprehensive... and there's proof that the whole team of auditors needs soft skills training? I'd want just a little more factual evidence than that, meself before leaping to that particular confusion :confused:

I second Marc's comments - some people do get very nervous, no matter how softly skilled the auditor is.

But perhaps there is scope to establish whether your auditor's use of trick questions is a/valid and b/effective? What about considering a discussion/interactive session in a group, rather than a 'I present' one? For example, roleplay different audit styles, make sure you include nervous auditee (as well as other modes?) and having others watch and critique? Get the auditee to talk about how they felt during the different types of audit. Strikes me the discussion would be the most important thing.
 
#5
I'm going to suggest something else. There's a sub-text here and the one employee was just the trigger for the complaint.

I would suggest that you take a look, not at the auditors and their soft skills, but at the way you plan and schedule audits. If you do them the way the vast majority of people do it, on a 'push' system with a whole year's of audits on a calendar, then you have an opportunity to do something dramatically different.
 
B

Bill Pflanz

#6
Before our first registration audit we did do some training for the auditees about what to expect and how to respond. I don't remember us doing that training for new employees but it sounds like a good idea. You may have to do some auditor training but may need to convince your boss of adding some auditee training.

Bill Pflanz
 
D

Deepu

#7
Hi Andy,

Thank you for the reply. We do it based on an annual calendar like you mentioned. But I am not sure I understood the change you indicated correctly. Is it that the particular department may be getting audited a little too many? We don't audit teams which are fairly compliant more than once a year.

Warm Regards,
Deepu
 
#8
Hi Andy,

Thank you for the reply. We do it based on an annual calendar like you mentioned. But I am not sure I understood the change you indicated correctly. Is it that the particular department may be getting audited a little too many? We don't audit teams which are fairly compliant more than once a year.

Warm Regards,
Deepu
Deepu - most audit schedules are a 'push system'. Your auditors 'arrive' to audit a process/department etc. to a schedule which is based on some criteria that you decide. This leads to suspicion of the purpose of audits, by management. In some cases, because they don't know what they're being audited for, they try to discredit the audit program. This looks like such a case!

Make this person your biggest advocate! Work with them when scheduling audits. Have the audit focus on something which is of interest/concern to them - turn the schedule into a 'pull system'. Talk to them about 'risk' and 'impact' - see this article here: http://www.nqa-usa.com/resources/articles_detail.php?id=48
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#9
I have been making an effort to (internally) audit people who have never before been audited. Knowing no one springs from the egg ready to be so quizzed, before I start asking questions I tell them, "This isn't a verbal exam - it is about how well our system provides you with everything you need to do your job well."

When they don't answer correctly, I give them the right answer and we run through it again after I clarify that one of the things I do is to help people prepare for being audited by outsiders. I will then let them know the boundaries of things they'll be expected to answer when being audited by registrars; we don't expect everyone to know everything about everyone's job, and there's no need to go on and on: just answer the question.

Last thing I do is make a point of asking if there is something they need - something I can help them get, or get done. Is this a kind of "gotcha" against management? It could be viewed that way, but after all we do promise they'll be given everything they need and it does give auditees the chance to see I'm not taking sides.
 
Thread starter Similar threads Forum Replies Date
O Soft and technical skills for a VP of Quality Career and Occupation Discussions 1
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
G Saline solution change for soft contact lens potting CE Marking (Conformité Européene) / CB Scheme 0
C Proper Thickness Gauge for Foam/Felt and Soft Materials General Measurement Device and Calibration Topics 5
rob73 Advice/recommendations for equipment to measure a soft pvc tube - Optical Measuring? General Measurement Device and Calibration Topics 4
M Declaration of conformity for "orthopedic soft goods" EU Medical Device Regulations 5
J What is soft auditing and soft grading in the IATF Rules 4th Edition? IATF 16949 - Automotive Quality Systems Standard 1
kedarg6500 Should soft annealing of Copper be done using regular air or in an inert atmosphere ? Manufacturing and Related Processes 2
Manix Measuring Soft Thermoset Plastics and Elastomers Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
M Zeiss U-Soft versus Uni-Touch CMM Software Calibration and Metrology Software and Hardware 7
G Document Control - Are hard copies required in addition to soft copies maintained? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Help find support manual for Zeiss CMM U-Soft, Ver. 3 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Control of Documents - Drawing (soft copy) for further work by other Consultants Document Control Systems, Procedures, Forms and Templates 1
H Reusable Soft Tissue Surgical Laser Fiber Sterilization Method US Food and Drug Administration (FDA) 3
E Soft Contact Lens - Medical Device Class 2 or 3? US Food and Drug Administration (FDA) 2
ScottK Soft Grading - What's your stance for the standards you work with? General Auditing Discussions 17
S Quality Manual - Possibility of maintaining only SOFT COPIES Quality Management System (QMS) Manuals 17
kedarg6500 Protection of Records in soft copies - Password needed? Records and Data - Quality, Legal and Other Evidence 4
F Conical gauges (ISO 5356) how to use on PVC (soft part) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
I FMEA Detection Rating - What is Soft or Hard? FMEA and Control Plans 7
Sidney Vianna Aerospace auditors are told to stop soft grading NC's. Or else! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 42
A Soft Ware program for control of the assembly/manufacture process Manufacturing and Related Processes 3
D Gage R&R on Felt, Flock and other Soft Materials Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
L How do you measure soft skills training efficiency? Training - Internal, External, Online and Distance Learning 12
R Would like a Soft Copy of ISO9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Soft Copy - Online Publishing Document Control Systems, Procedures, Forms and Templates 9
D Testing for Cracks - Molded parts which are very soft before they are cooked General Measurement Device and Calibration Topics 8
K Monitoring the identified side-effects and contraindications ISO 14971 - Medical Device Risk Management 4
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
W Surveillance report along side an NCR program Nonconformance and Corrective Action 2
M IATF 16949 - TS vs IATF side by side IATF 16949 - Automotive Quality Systems Standard 2
P Accounting for Variability on High Side of Specification Reliability Analysis - Predictions, Testing and Standards 1
Chennaiite FMEA - The Funnier Side Imported Legacy Blogs 5
M Is information required on more than one side of box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Presentation Invitation on ISO13485 from the Distribution Side ISO 13485:2016 - Medical Device Quality Management Systems 1
B ISO 9001 Application to my Business for the Production side of things only ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Pre-Control Chart for Single Side Tolerance Statistical Analysis Tools, Techniques and SPC 1
G Permit to Fly - Is flight testing relevant to our production side? EASA and JAA Aviation Standards and Requirements 6
A Is Disposition Applicable if We are in the Service Side of the Industry? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L ISO 9000 Internal Self Assessment on the Operational Side - Your Comments? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Marc The Value of ISO 9001 Registration and the 'Dark Side' of Implementation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T Control Plans - Right hand side of the control plan was a flow chart FMEA and Control Plans 3
Marc Hacker Hunters - An elite force takes on the dark side of computing After Work and Weekend Discussion Topics 0
S Side by Side comparison of calibration softwares? Calibration and Metrology Software and Hardware 1
S Question About Rockwell Verification Blocks - Testing on the back side of the block General Measurement Device and Calibration Topics 10
S Looking for software one side tolerance GD&T Quality Assurance and Compliance Software Tools and Solutions 1
R ISO 9001:2000 - Control over the Accounting/Financial Side of Things ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
E Sales and Marketing - How I can get them on my side Misc. Quality Assurance and Business Systems Related Topics 12
S Consulting on the side - What arrangements did you make with your employer? Consultants and Consulting 7

Similar threads

Top Bottom