Documentation for ISO9001-2000

I

ivan99

#1
:frust:
SOP's, Work Instructions, Training Manuals?? where is the demarcation line?? Can I build a robust QMS based on few SOP's and WI's and heavy on training manuals?? Are training manuals subject to document control??
 
Elsmar Forum Sponsor
D

David Mullins

#2
As QA Manager, it's your call.
Just get everyone else to agree, and make sure it complies with whatever it needs to - EASY!?!?!
 
N

noboxwine

#3
Here's a twist.

ivan99 said:

:frust:
SOP's, Work Instructions, Training Manuals?? where is the demarcation line?? Can I build a robust QMS based on few SOP's and WI's and heavy on training manuals?? Are training manuals subject to document control??
Here's a left of center, but effective way to look at it. Put the ISO book in the bottom drawer. Build an effective QMS using the tools you need to maintain it's effectiveness. Test it over a reasonable amount time. If it works, then pull out the bottom drawer and fit the system into the standard and see if you have gaps. Fill them accordingly. KEEP IT SIMPLE PLEASE !!!!!!!!!!!!!

MORAL OF THE STORY: Fit your program into ISO. Not ISO into your program. When it comes time to read the standard, start at page 9 and read through 22. Read it as written, not between the lines. Amazingly, you'll see that you have the flexibility to run your business effectively without changing the world. And for God's sakes, don't let an auditor with "short man's disease" or anyone else put you in a corner noting a noncompliance to the standard when indeed they're simply not agreeing with your business practices. Good luck and have a day.
:smokin:
 

gpainter

Quite Involved in Discussions
#4
Most companies over document, ISO was never meant to be a document nightmare. Although, many consultants have suggested to over document and Work Instruct everything. And many companies have. Lean, mean and train. The key word TRAIN.
 
D

David Mullins

#5
Could I please have a dollar for every half-arsed CAR response I've received over the years that said "operator to be retrained".
I'll hand out a C note for every CAR that says they would implement a system to prevent it happening again.

Training, sure, but sometimes we have to make systems that don't rely on people - they aren't that reliable!
 
I

IceZebra

#6
David,

I couldn't agree more.

I have started the process of rejecting every CAR that lists Operator Error as the root cause. You can train all you want (and should) but unless you make your process error proof... Murphy's Law.

And I thought our process guys were confused before. :confused:
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
Systems that don't rely on people? Operator error not possible/never acceptable? Maybe I'm just dumb, but I think I need some more explanations on these opinions because as blanket statements they do not jive with my experience and beliefs. Please, educate me.
 
I

IceZebra

#8
Mike,

David Mullins:
...systems that don't rely on people...
I think what David was trying to say was don't rely on people to do it correctly. Make the process robust. (Correct me if I'm wrong Dave!)

The point I was making was if the process allowed the operator to make an error, then there is something wrong with the process, not the operator. It is important to point the finger at the process and not the person working on it.

For that reason alone, I reject all CAR's with Operator Error, unless they can give me a plausible explanation (which they haven't to date).

Now, let me qualify where I am coming from. I work in the automotive industry so I can only speak from my experiences there. For other industries, perhaps my statement was a bit of 'shooting from the hip'. (Maybe Marc could offer a 'foot in the mouth' smilie for just such a thing ;) )

I hope this clarifies my thoughts...
 
#9
Not always the process

The point I was making was if the process allowed the operator to make an error, then there is something wrong with the process, not the operator. It is important to point the finger at the process and not the person working on it.
I think there are times where we can legitimately say it was operator error. Not all processes can eliminate the human element. Sometimes the best we can do is to install checks so the error doesn’t make it very far without notice. I too reject “retraining” as the fix. Most cases, it was not a training issue, it was an execution issue. The employee knew what to do (or not to do), put performed otherwise.

Also, we can never safeguard completely from sabotage. My uncle used to work on the assembly line. After the afternoon break, the next vehicle going down the line would have a pop bottle in the passenger’s door. He did it to “drive the dealership crazy”. I’ve seen fuel tanks with hats and rags deliberately stuffed inside of them.

In many cases, the best the process can do is to detect and isolate such errors (whether they be accidental or intentional)
 
I

ivan99

#10
I tyhink I got the pic!! but we drifted frommy original question to training as emphasis and that was definitely not my intent. All I was aking is semantics...the difference between a document called SOP or whatever and another called Training Manual...they bith contain the same info...which one do you choose...that's all I was asking about! Sorry for any confusion on my part...Please keep it going...
 
Thread starter Similar threads Forum Replies Date
T Incorporating your employee handbook into the ISO9001:2000 documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N ISO9001:2000 Documentation/Activities Recording Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Identifying Changes to Documentation - ISO9001 Clause 4.2.3 c ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K Combining ISO17025 with ISO9001 Documentation - Product is standard solutions ISO 17025 related Discussions 3
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
C Gobys for operations documentation plan Oil and Gas Industry Standards and Regulations 4
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
K ITAR Visitor Documentation of Citizenship AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
A Process Documentation for ISO 9001:2015 Internal Auditing 2
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
F ISO 17025:2017 mandatory documentation requirements ISO 17025 related Discussions 1
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
F PPAP Documentation Control APQP and PPAP 8
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
DuncanGibbons Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers Manufacturing and Related Processes 0
V What is the criteria to cite an good documentation practices observation as an data integrity related issue US Food and Drug Administration (FDA) 6
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
L ISO 9001:2015 standard documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
W Documentation - Use of Addendum vs Amendment Document Control Systems, Procedures, Forms and Templates 1
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
D QMS Documentation Process - I want to put all the Process SOPs to a QMS system Document Control Systems, Procedures, Forms and Templates 3
T QMS - Documentation Cloud Storage EU Medical Device Regulations 0
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
B Quality Management System documentation identification Document Control Systems, Procedures, Forms and Templates 11
J Training documentation - ISO 13485 audit and the auditor had questions General Auditing Discussions 7
D Documentation requirements for the new Medical Device Regulations (2019) CE Marking (Conformité Européene) / CB Scheme 5
Ashok sunder ISO 45001:2018 Documentation template Occupational Health & Safety Management Standards 4
M Informational BSI – MDR Documentation Submissions Best Practices Guidelines Medical Device and FDA Regulations and Standards News 0
R DMR or Manufacturing Documentation - How detailed does the documentation have to be? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Is Software code documentation required for FDA premarket submissions? IEC 62304 - Medical Device Software Life Cycle Processes 2

Similar threads

Top Bottom