SBS - The best value in QMS software

We shouldn't have windex in manufacturing area - Is the auditor right?

Elsmar Forum Sponsor
M

Mike_H

#32
I think that the initial post, and the first response to it (by Steelmaiden) were all that was necessary. :cool:
agree with that Jim...I'd want to be 100% sure that any verbal comments are understood and wording agreed at close-out. Anything that's said "off the cuff" and isn't written down can stay that way as far as I'm concerned. If it's an "opportunity for improvement", well then dispute it at close-out if you feel more information is required, otherwise forget it and move on.

:topic: I read somewhere that coffee on the shop-floor is bad too for certain metallics...I think Aluminium (aka Aluminum)... must be a corrosive I'm guessing. I should try to cut back... :cool:
 
R

RandT

#33
Seeing this thread brought back memories.

I worked for an auto glass manufacturer for many years. We used Windex all the time with no thought; I mean it was made for glass cleaning, so how could it ever cause any issues? I mean we used several gallons a day throughout the entire plant thinking the cleaner we got the glass, the better it had to be.

We had an adhesion issue with one of the components we bonded to the glass, and after a lot of lab analysis, it looked like the Windex wasn't necessarily the cause of the failure, but did leave a residue that did have some negative impact on adhesion. As a result, Windex was immediately banned from the plant, and a lot of the employees went home with a bottle of it that day.
 
C

Charlie H

#34
Well just to let everyone know. That auditor will be back in a couple of weeks. While she is here we are going to request to see the proof.

I will keep everyone updated.
 

Jim Wynne

Staff member
Admin
#35
Well just to let everyone know. That auditor will be back in a couple of weeks. While she is here we are going to request to see the proof.

I will keep everyone updated.
Thanks for the update. I think you need to think about how you approach this issue, though. If this was indeed an offhand comment, and not intended to be a catalyst for correcting the situation, you'll probably be best off not bringing it up at all. If she does bring it up, rather than asking the auditor for evidence, you might just say that you evaluated the situation and decided that the risk was negligible and outweighed by the need to provide a method for cleaning machine windows. In the meantime it might be a good idea to alert your operators to the concern, if you haven' already.
 
Last edited:

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#36
Thanks for the update. I think you need to think about how you approach this issue, though. If this was indeed an offhand comment, and not intended to be a catalyst for correcting the situation, you'll probably be best off not bringing it up at all.
I agree. I would not make anywhere as near of a fuss about it with the auditor as we did in this thread. This is a much more academic discussion - including trying to figure out where the notion came from in the first place.

You could 5S the windex someplace while the auditor is there, just to keep it out of the conversation.
 

SteelMaiden

Super Moderator
Super Moderator
#37
or, just politely say "the last time you were here you asked if we had evaluated the effect of Windex on our product. We've done quite a bit of research but have not found anything to suggest a problem. If' you are aware of something that suggests otherwise, we'd love to see the data if you'd be so kind to point us in the right direction."

eta: please, if you or any of us have something come up in an audit that they are unsure of....ask your auditor, in a non-argumentative way, what they are talking about, or if they can provide evidence to back up their comments. I've only met 2 auditors in my 20 years of QA work that would not have helped me out if I asked them for clarification. Believe me when I say that I've dealt with a lot of auditors. Some I've liked more than others, but almost all of them are very nice people.
 
Last edited:

Wes Bucey

Prophet of Profit
#38
or, just politely say "the last time you were here you asked if we had evaluated the effect of Windex on our product. We've done quite a bit of research but have not found anything to suggest a problem. If' you are aware of something that suggests otherwise, we'd love to see the data if you'd be so kind to point us in the right direction."

eta: please, if you or any of us have something come up in an audit that they are unsure of....ask your auditor, in a non-argumentative way, what they are talking about, or if they can provide evidence to back up their comments. I've only met 2 auditors in my 20 years of QA work that would not have helped me out if I asked them for clarification. Believe me when I say that I've dealt with a lot of auditors. Some I've liked more than others, but almost all of them are very nice people.
Excellent spin!

I agree, most auditors (second or third party) are willing to share knowledge when asked in the right (nonconfrontational) manner.

But then that holds true for most folks, auditor or not, we all want to be heroes or heroines in our own story and, by definition, the hero is the GOOD GUY!
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#39
or, just politely say "the last time you were here you asked if we had evaluated the effect of Windex on our product. We've done quite a bit of research but have not found anything to suggest a problem. If' you are aware of something that suggests otherwise, we'd love to see the data if you'd be so kind to point us in the right direction."
I would not even bring it up if it was not a finding. But, if the auditor mentions it, then I would use that approach.
 
Thread starter Similar threads Forum Replies Date
D Non Conformance Closure - Shouldn't this be the Quality departments responsibility? Nonconformance and Corrective Action 3
P Why women shouldn't take men shopping... Funny Stuff - Jokes and Humour 12
M Same auditor shouldn't do two consecutive Internal Audits on same Process/Procedure? General Auditing Discussions 12
P Why men shouldn't own action figures Funny Stuff - Jokes and Humour 3
L Why QA (quality assurance) shouldn't be in Operations Misc. Quality Assurance and Business Systems Related Topics 27
R I was told that the MR (Management Representative) shouldn't be doing internal audits Internal Auditing 19
S CE and Manufacturing license Manufacturing and Related Processes 1
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
P How to measure DPPM in Chemical batch manufacturing Quality Tools, Improvement and Analysis 1
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
K One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
S Manufacturing Execution Systems Software Costs Manufacturing and Related Processes 0
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
DuncanGibbons Additive Manufacturing Processes Thread Manufacturing and Related Processes 5
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H Line Balancing in Backpack Manufacturing Manufacturing and Related Processes 2
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L SAE AS9145 vs. SAE AS6500 (Manufacturing Management Program) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
qualprod Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom