SBS - The best value in QMS software

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

C

Charlie H

#21
#21
I'm sorry I don't respond to your responses in a timely manner.

The windex is:
company supplied & used on the floor to clean machine windows.

We have emailed her and currently waiting for a response.
 
Elsmar Forum Sponsor
Q

QA Lady

#22
#22
I say as long as it is properly identified with
shelf life and OSHA NFPA labels you are
meeting requirements.
 
R

Rick Hart

#23
#23
This is definitely not a nonconformance! The only areas he could site you would be if your work instructions specified a cleaner other than Windex and it was observed that Windex was being used. The other area he could site you would be if the Windex was in an unidentified bottle. That's it.:bonk:
 
Wes Bucey

Wes Bucey

Prophet of Profit
#24
#24
It could be argued this auditor was engaging in "consulting" by commenting the window cleaner could have an adverse effect upon the product and/or material.

The fact the cleaning product is supplied by the organization and that managers are satisfied employees know proper way to use said product doesn't leave much room for an auditor to assign NC, but the auditor could possibly offer an Opportunity for Improvement by suggesting the organization "confirm" any cleaning product will have no adverse effect upon the material - most MSDS sheets merely address adverse effect upon humans and other living creatures.
 
Jim Wynne

Jim Wynne

Staff member
Admin
#25
#25
Wes Bucey said:
It could be argued this auditor was engaging in "consulting" by commenting the window cleaner could have an adverse effect upon the product and/or material.
Click to expand...
Auditors should be allowed to make informal, off-the-cuff observations without being concerned about being accused of consulting. By the same token, auditees should always ask questions if a such a comment seems like it might be meaningful in some way.
 
A

AndyN

Moved On
#28
#28
Roybe1950 said:
Auditors should stick with auditing and not utter non-relevant comments
Click to expand...
Absolutely correct...however, the problem is the auditor likely thought it was relevant.......and apparently no-one knew enough to point out the error of his/her ways.

The dilemma is that everyone (well, mostly) is trying to get 'value' out of their CB audits and so do many of the CB auditors. The difficulty faced, then, is deciding when a comment is well placed and accurate or not - and sometimes the client doesn't know, doesn't want to seem 'dumb' and doesn't know the auditor doesn't know better, either......
 
D

Desara01

#29
#29
Bwaaa ha ha ha ha.!:lmao:


There's probably ammonia in her hair dye - maybe she shouldn't be out there either.

People stop letting loons like this get away with it! Call them on it EVERY TIME.
 
Jim Wynne

Jim Wynne

Staff member
Admin
#30
#30
Desara01 said:
Bwaaa ha ha ha ha.!:lmao:


There's probably ammonia in her hair dye - maybe she shouldn't be out there either.

People stop letting loons like this get away with it! Call them on it EVERY TIME.
Click to expand...
I think that the initial post, and the first response to it (by Steelmaiden) were all that was necessary. :cool:
 
You must log in or register to reply here.
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