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
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 0
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
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item? Measurement Uncertainty (MU) 10
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
DitchDigger Boston Fire Code: Who Does What? (CAL TB 117-2013; CAL TB 133) Occupational Health & Safety Management Standards 2
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
C Does ITAR apply to Exporters only? Other ISO and International Standards and European Regulations 6
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5

Similar threads

Top Bottom