Does notes posted on machines have to be controlled?

Elsmar Forum Sponsor
C

C Emmons

#2
Yes. However, I am speaking from personal experience. I had an auditor write us up for a zip code list that was posted in a dispatch office, as well as cheat sheets with account numbers posted on computer monitors. Better to be safe than sorry.
I try to follow the rule of thumb: If it is important enough to post, control it, if not , get rid of it.
 
C

Craig H.

#3
DWPOZE

Welcome to the cove!

As far as the notes go, I would say that it depends.

Assuming we are talking about an ISO 9001:2000 system, the main clause is 4.2.1, and 4.2.3 also applies.

You didn't say what the notes contain, but according to 4.2.1d, if they are needed to ensure "...effective...operation and control", then the documents (notes) should be "...established, documented, implemented and maintained". So, my take on the "maintain" is, yes, if the note is needed for operation and control, it should be maintained - as a controlled document. Clause 4.2.3 tells us just what this control entails.

Hope this helps.

Craig
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
Dwpoze,

Welcome to the Cove! Good question!

I think it depends on what the "note" says, and to a lesser degree who the auditor is.

If the note says "all guards must be in place before operation" or "turn off the lights before leaving on Friday" or "this week's quality goal is 98% yield" or something like that, I'd say no.

If it is related to, or can effect, the quality of the product I'd say yes, it should be controlled. But I'll also admit to using uncontrolled cheat sheets from time to time. C Emmonns' rule of thumb is not bad, it is probably the safest bet, but sometimes there are gray areas that I get stuck on.

If I read the controlled procedure, and there are a few equipment settings I need to remember but the rest of the procedure I don't need, I'll sometimes write these settings on a Post-It and use it for a few days as I process various lots of material. I transcribed the data from the controlled doc to an uncontrolled doc. If I had written it on a process record for a single lot, no one would probably say diddley, but if I put it on a Post-It to use for a few days and multiple lots, even if I KNOW the process did not change in the interim, an auditor probably would not like that. If I had kept it in my memory (or tried to) no one would know. I could show proof that the numbers were correct if asked, but this might not get me off the hook. Gray area to me. I'm personally not too much of a stickler on these notes if they are very temporary.

Others???
 
N

noboxwine

#5
Re: Notes on Equipment

THAT ONLY DEPENDS ON ONE THING: HOW YOU WRITE YOUR CONTROL OF DOCUEMENTS PROCEDURE. YOU MAKE THE CALL. I WOULD FINE IT VERY COSTLY AND COUNTER PRODUCTIVE TO CONTROL NOTES, WOULDNT YOU ? ????????? WRITE THE PROCEDURE TO FIT YOUR NEEDS AND MAKE IT SIMPLE. GOOD LUCK !


DWPOZE said:

Question????

Does notes posted on machines have to be controlled?

Thanks,

Dwpoze
:D
 
#6
Hi DWPOZE, and welcome to the Cove. :bigwave:

The question you need to ask yourself is: Is this note "just a note", or is it in fact an uncontrolled written procedure?

We have quite a few controlled written procedures (in some cases excerpts of procedures) posted on the machines.

/Claes
 
D

D.Scott

#7
Here's a "jump ball" for you.

(in some cases excerpts of procedures)
If you post an excerpt, haven't you in fact modified the original procedure by eliminating a portion of it? Wouldn't that be the same as changing the original by deleting whatever you don't want? It would seem to me that unless you give the excerpt a new number and then control that, you would be creating a nonconformance.

I had an auditor tell me at a seminar that all "post it" notes had to be controlled or they would be a nonconformance. I told him that may be true in an absolute sense but if he ever wrote it up, he would never be back to my company. End of debate.

Auditors would like to see all documents controlled. It makes an easier life. In fact, all documents don't have to be controlled. You can determine which documents require control and develop a system to control them. Only those which relate to the requirements of the International Standard MUST be controlled and even at that, you have latitude in how you control it.

As with much of ISO/QS/TS, ask "does this make any sense?". If not, why would you do this just to make your auditor happy? He works for you, not the other way around. If you don't think it makes sense, ask him to explain it. If you get "that's the way I interpret it", or "we aren't allowed to consult", call me - I will give you a list of a whole lot of registrars who would like to talk to you.
There are many auditors who are now becoming professional and don't have to go on ego trips showing how they know the letter of the law. The good auditor helps your company by recognizing areas of your system that might affect the relationship with your customers, not on how you notify employees of the upcoming company picnic.

Just my own (getting tired) opinion.

Dave
 
#8
D.Scott said:
Here's a "jump ball" for you.

If you post an excerpt, haven't you in fact modified the original procedure by eliminating a portion of it? Wouldn't that be the same as changing the original by deleting whatever you don't want? It would seem to me that unless you give the excerpt a new number and then control that, you would be creating a nonconformance.
----X----
Dave
Hi Dave,

hehehe... I was rather expecting someone to bite on that one. :p

Actually, no (imo). The operators have access to the complete documents as well, via the intranet. However, they use some parts of the documents (usually tables, lists and such things) more or less continually, and that would make it awkward to access them from intranet.

So we post the excerpts they need on the machines. When they need the additional information in the complete document they just go to the intranet. We have a database to keep track of not only all recipients of written procedures, but also in what form they need them: Paper size, excerpts, media, you name it.

It works for us, and the external auditors never even squealed in protest. Quite the opposite in fact. They like it, because it prevents information overload.

/Claes
 
#10
No problem there...

The issue can be found in the document header (The smallest excerpt is one page - I should have mentioned that), and can be compared with the complete version (always the current issue) on the intranet. Thus, anyone can verify that they are using the correct issue at any time.

Of course any send-out of new issues includes the excerpts too.

/Claes
 
Thread starter Similar threads Forum Replies Date
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 1
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 0
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 14
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
M Does C=0 strictly mean 1 bad, all bad, all the time? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 5
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
M What does "constantly" mean ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
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 8
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
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom