How does your organization react to customer audits?

ScottK

Not out of the crisis
Staff member
Super Moderator
#1
I am strongly of the mind that customers should be welcomed into my facility to audit our processes as part of our continual improvement plan.
I'm not frightened, I see no need to "cram" as if for an exam, and I welcome any suggestions that they may have.

Unfortunately, in more than one place I've worked, customer audits are dreaded. They're dreaded like final exams are dreaded in school. Senior management insists on meeting after meeting to make sure our butts are covered.

But few of these are "pass/fail" audits. Business doesn't hinge on them, they are existing customers, they are no based on an inordinate amount of complaints. It's the customer following up on his supplier surveillance process.

I suppose, in my current position, once I have my internal audit process going most of this fear will go away. I hope.
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
I am strongly of the mind that customers should be welcomed into my facility to audit our processes as part of our continual improvement plan.
I'm not frightened, I see no need to "cram" as if for an exam, and I welcome any suggestions that they may have.

Unfortunately, in more than one place I've worked, customer audits are dreaded. They're dreaded like final exams are dreaded in school. Senior management insists on meeting after meeting to make sure our butts are covered.

But few of these are "pass/fail" audits. Business doesn't hinge on them, they are existing customers, they are no based on an inordinate amount of complaints. It's the customer following up on his supplier surveillance process.

I suppose, in my current position, once I have my internal audit process going most of this fear will go away. I hope.
Although it's not an issue where I work now (a large OEM) I've had to deal with customer audits in the past, and generally consider them a necessary evil. On the other hand, I've always welcomed customer visits and have encouraged customers to come in and see what was going on.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
Although it's not an issue where I work now (a large OEM) I've had to deal with customer audits in the past, and generally consider them a necessary evil. On the other hand, I've always welcomed customer visits and have encouraged customers to come in and see what was going on.
the only time I have an issue with a customer audit is when they REQUIRE corrective or preventive actions to our systems based on their observations.
L'Oreal Corporate was horrible with this in two place I worked, demanding copies of our CAPA reports in a shorter period than required by our internal procedure.

The way I see it is that I'm wide open to suggestions. But demands I'm automatically going to fight.
 
#4
I'd suggest that it all depends on the auditor. I've witnessed customer audits that were well received and the reverse. You're correct that there should be no need to 'cram' before the visit, but does everyone else back at base have the same comfort zone?

Andy
 

SteelMaiden

Super Moderator
Super Moderator
#5
Come one, come all. Although we are not necessarily overjoyed when someone wants to audit us, it's nothing but a thing. We welcome all of our customers to visit.
 
C

Craig H.

#6
In my experience I would rather have a customer audit done by people who are competent in (or even familiar with) the ISO 9001 approach than someone who is merely "auditing" against their opinion, or what they are used to doing "back home".

Not only is the former more likely to be more able to look at the process(es) objectively, their input will more than likely be of some good use.

The latter, on the other hand, can be a monstrous combination of a goose chase and a snipe hunt. No fun whatsoever.
 
R

ralphsulser

#7
I agree with Andy, it depends on the auditor. During registrar audits there is an opportunity to challenge the auditor if you disagree, or show me. Customer audits have too much discretionary or dictatorial decisions by the auditor. Some times it is used as an excuse to make a return visit. I can site examples of audits where other customer and registrar auditors thought our system was fine, but one customer auditor wanted to be dictating major CAs even if we had documented evidence we addressed the issues.

This is not new, and has been going on for at least 40 years. Makes one wonder how much the management of customer auditors is involoved in evaluating these reports.
 
R

RosieA

#8
I generally enjoy customer audits...I've been the recipient of many over the years in different companies. I find that they kind of fall into several categories:

1. People who come in with an open mind and listen to your explanations in light of your situation. They're interested in a partnership and in understanding. There are often great opportunities to learn from them, and they from you.

2. People who come in with tunnel vision and only want to see things from their perspective or their system. They want to "fix" you, even if you don't need fixing. These people are driven by some internal mandate and inflexible idea about what quality is and that the only way to achieve a good outcome is from THEIR process.

3. People who come in with an axe to grind and nothing you say will ever be accepted. You might as well just sit there and take it, because nothing you say or do is going to matter.

4. People who are there to check you off their list. They write a finding or two and move on.

Obviously, I like customer #1 the best. :D
 
Q

Quality Girl

#9
I've been part of customer audits from both sides of the table, and I have to say that the open, honest approach is always easiest on all parties. There is no point in the auditee expressing resentment at the audit, as the auditor is merely fulfilling a requirement (be it regulatory or internal procedures). When doing supplier audits I never took the approach that I was looking for errors, rather that I was there to verify compliance with whichever regulation/QS was appropriate. If all auditors explain this from the start, and stick to that mindset then I think the whole aduit experience is more positive, and should be seen as constructive rather than detrimental.
Clare.
:yes:
 
J

Jgryn

#10
Perhaps the key is to give the organization something to prepare for customer or external audits/visits.

Here is a list that I like to follow that helps everything run smoothly.

1 - If this is an overnight visit, book a hotel room for them, making sure they get your company's hotel rate.

2 - Arrange pick-up at the airport if necessary.

3 - Book a conference room for the entire day. Review the room before anyone arrives to make sure it is clean and free of confidential material (open the white boards)

4 - Book a small room or office if you think they will need somewhere to make calls/conduct business during the day. Always good for visiting SQA's who never truly stop running, or need a nap. :)

5 - Have water, coffee, tea, juice, snacks available all day. Have breakfast, lunch and dinner brought in. Do not order Pizza. Do not count on going out unless it was requested ahead of time.

6 - Have management concentrate on Housekeeping only. This will help make a good impression and keep them busy.

7 - Have management ensure that all confidential material is cleared away/locked, especially if it is associated with another customer and/or financial.

8 - Line up a couple of guides, especially if you have a group visiting. If your visitor is a smoker and you are not, assign someone who does smoke to accompany them on all breaks.

9 - Try to set up an agenda, even if it looks like:
Meet and greet
Tour Plant
Lunch
Tour labs and Warehouse
Wrap-up

10 - to avoid any potential issues record everything that they say, any comment, official or unofficial. If they ask for action specifically, write it down and assign someone else to track it down. Do not wait around for someone to 'find' something if at all possible.

Cheers,

Jen
 
Thread starter Similar threads Forum Replies Date
Q Does ISO 9001 Requirement for Document Approval (a service organization) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S ISO 14001 Clause 4.1 Organization and its context - What does an Auditor expect? ISO 14001:2015 Specific Discussions 12
D Where does the QMS (Quality Management System) fit in your organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
J How does your organization store documents for Class I and Class II Medical Devices? Benchmarking 4
T Does Organization Size change a QE's Required Knowledge? Career and Occupation Discussions 1
M How Does Your Organization Measure Cost of Quality? Benchmarking 14
N Does OHSAS 18001 require organization to have AED (Automatic External Defibrillator) Occupational Health & Safety Management Standards 4
B How does an organization ensure valuable employees are taken care of? Career and Occupation Discussions 10
P Does anyone know any organization with IMS (QMS+EMS+ISMS)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Quality Organization - Does it matter where it reports to? Other US Medical Device Regulations 13
I Does your organization include Finance & Accounting documents in the QMS? Document Control Systems, Procedures, Forms and Templates 16
V ISO 9001:2008 - How does an organization demonstrate "sustain success"? General Auditing Discussions 14
Hershal Definition Preventive Action - Definition - How does YOUR organization define PA? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
D Does TS Organization have to use the Design Information Checklist? Design and Development of Products and Processes 1
M Does "Environment" include air, water, land...etc. within the organization Miscellaneous Environmental Standards and EMS Related Discussions 4
B Does Your Organization Need Free Audits or Do You Need Audit Experience? General Auditing Discussions 7
A Does Your Organization Really Benefit from Internal Audits? Time for a Change? Internal Auditing 149
D Global Motors - Does your organization (workplace) receive government subsidies? World News 31
R In a perfect world, who does the Quality Organization answer to? Philosophy, Gurus, Innovation and Evolution 18
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3

Similar threads

Top Bottom