Detail Required in Documented Procedures

S

Steve

#1
What is the level of detail generally required in a documented procedure? My approach was to make the procedures fairly "vague" (or open ednded) and expect the person performing the procedure to use their best judgement. Other people at my commpany seem to want to include every little detail they can think if. So I am unsure of what level of detail is necessary in the procedure.

For example, I said that, for our ESD prcedure, that ground connections should be inspected to ensure that they are in good repair. Is it enough to leave it at that? Or do I need to "define" what the requirements for "good repair" are. This would seem to me to be overkill. Is it unreasonable to asume that the person making the inspection has the judgement to determine what "good repair" is?

Any thoughts you have would be appreciated.

Thanks,

Steve.
 
Elsmar Forum Sponsor
E

energy

#2
How about using an Ohmeter to verify continuity and visually inspect connectors and cable (wire) for wear or damage?
That's not too many more words and kind of narrows it down a bit.
energy
 
M

MrPhish

#3
I see that a good part of your QMS relies on qualified personnel to perform the work, not just written procedures and work instructions. Look at ISO 9001:2000 section 4.2.1 NOTE 2 " The extent of the QMS documentation can differ from one organization to another due to c) the competence of personnel."
This tells me that as I increase the use of more qualified (and now competent) personnel my amount and detail level of documentation can (doesn't have to) go down (inverse proportion).
Now a danger in this scenario is that if these "qualified and competent" personnel don't perform well ... then the absence of "detailed guidance" may be brought up by the external auditor as a flaw in the QMS. Its a tough call. I think a company has to make sure all of its employees understand the goals of the company and what is expected from them. Then when they are forced to make a decision (maybe based on a lack of "written detail") they can rely on their understanding (and skills)of what is expected of them as employees to make the right call and make the quality decision.
Another down side of less detail is if you have a bunch of "Sea-lawyers" working with you. They question everything that is not laid out in front of them I guess so they don't have to think for themselves. Less detail works well with self motivated employees who understand that the whole game is about customer satisfaction.
Its hard to know how much or how little is correct. Good luck on the high wire.
 
T

tim banic

#4
Another thing you will have to watch out for, is training records of your staff. You will have to show that they are compitant to make the decision whether the product is good or bad.

one reason for detailed work instructions is when you need to train new staff in that position...what documentation do you use to train them. Eventually yes they will become compitant enough to do the job with out looking at the work instruction but until then, they need something to reference.

Hope this helps

tim banic
"if it moves, train it...if it doesn't move, calibrate it...if it isn't written down, it never happened!"
 
D

David Mullins

#5
STEVE,
From the methodology that I employ, the short answer is that it depends on the standardisation already inherent within the organisation at the time you write these procedures. You are a change agent - don't make the change so big that you lose everone on the way.

ESD EXAMPLE:
Unfortunately this is not a good example for my point. Let's say that different areas within the org were using different inspection methods, and some didn't perform inspection at all. This is a prime candidate for establishing a standardised work practice where you want everyone to perform an inspection, but don't take it to the Nth degree of stipulating the actual inspection instructions - hance a major change for some, and no change for others.
In reality we clearly need to stipulate what the inspections consists of, which can be stated in the procedure, an annex to the procedure, or a separate work instruction. This represents major change for some, minor change for some, and no change for the others.
Why do we have to stipulate the inspection methodolgy? Because (and this utilises the basic principles of quality - every process has variation, if you don't control it you can't improve it, &, If you don’t measure it you can only change it you don’t know if you improved it) you will get greater variation in measurement outcomes without it, thus increasing process capability spread to the point that you can't actually calculate it because you don't control the process.

Also to take into consideration, is this degree of standardisation going to adversely impact user impressions, to the extent that it turns them off the quality system all together. In this case I don't think the impact is going to be Earth shattering - indeed this kind of things reduces or eliminates barriers that previously existed between work groups.

I could say more but I've got work to do.
Let me know if you want more dribble :)
David.



------------------
 
D

Dan Larsen

#6
My approach...

The policy defines why.

Procedures define who does what and when.

Instructions (or another document vehicle) defines how.

In you example for the ground connectors, I'd say the procedure would be OK (except for possibly defining the frequency). An instruction would be used to define acceptance critertia.
 
R
#7
Hi Steve,
I agree with Dan. In your system, too many corrective actions may point to a need for specific work instructions.
Mike
 
F

Fire Girl

#8
Our system, is a very cumbersome one. At least that's my opinion.

However, I will tell you how we do it. We have a general procedure manual which basically laid out on the same format as the Standard. Then I have operations manuals for Production, Toolroom and QA. In the Operations Manual are the specfics on how to do the job. I feel these are still fairly vague, and taking into account the Operators are skilled setter/operators. They also have 'Set-Up Instructions'. There is a Set-Up Instruction sheet for EVERY job that we run. This gives sort of 'tricks' for setting up that particular job.

For the ISO 9k:2K I am hoping to go to shaved down procedures and flow charts....
 
Thread starter Similar threads Forum Replies Date
P ISO 9001:2015 4.2 and 6.1 - Interested Parties - How much detail is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B Shop Traveler/Router Detail Required Document Control Systems, Procedures, Forms and Templates 6
R Level of detail required - Results of Corrective, Preventive Action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M 8.2.4 Monitor and Measure Question - Re: Sub-Assemblies and Level of Detail Required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Quality plans - How much detail is required? What is typically included? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M AS9102B Detail Part/Assembly FAI Form 1 box 13; AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 4
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
L AS9102 Form 1 Section 13 Detail or Assembly Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M FAI Requirements of Detail and Assembly AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P What is a Tooling Detail form? APQP and PPAP 2
T 510k Level of Detail Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
P Development and Approval of New Products - Procedure Length and Detail Document Control Systems, Procedures, Forms and Templates 1
D AS9102 FAI - Detail vs Assembly FAI (Form 1, Box 13) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
T ISMS (Information Security Management System) Task Flow Chart in 'Detail' IEC 27001 - Information Security Management Systems (ISMS) 7
R Level of Detail in a Quality Manual vs. a Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
M Quality Procedures - General Detail Level and Record Keeping Requirements Document Control Systems, Procedures, Forms and Templates 6
Q Document Control Procedure - Too much detail? Document Control Systems, Procedures, Forms and Templates 8
H Calibration Procedure Level of Detail - ISO Procedure question Document Control Systems, Procedures, Forms and Templates 8
M Applying EN 62304 - Medical Device Software Architecture - Level of Detail IEC 62304 - Medical Device Software Life Cycle Processes 21
A Quality Control vs. Quality Assurance in detail with example? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q How much detail in DHR (Device History Record) is too much? US Food and Drug Administration (FDA) 3
A Identification and Traceability down to the smallest detail of the component AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
P Separating "Shall" requirements from "Should" detail ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
N Quality Program Plan - How much detail does the customer want? Quality Manager and Management Related Issues 1
J Level of Technical Detail of Technical File Submission ISO 13485:2016 - Medical Device Quality Management Systems 1
J Quality System Process Map - Is this too detailed or not enough detail? Process Maps, Process Mapping and Turtle Diagrams 77
M Control of Detail Prints Document Control Systems, Procedures, Forms and Templates 11
U PPAP and AQAP Training - I really want to learn PPAP, APQP, and QS-9000 in detail Training - Internal, External, Online and Distance Learning 3
K ISO 14001:2004 - 4.3.2 Legal & Other Requirements - Level of detail expected ISO 14001:2015 Specific Discussions 18
R Updated Process FMEA: How much detail? Closure of an External Corrective Action FMEA and Control Plans 3
V References instead of Detail - Control Method and Reaction Plan FMEA and Control Plans 5
C What is acceptable quality manual content? How much detail to put in here? Quality Management System (QMS) Manuals 25
K Supplier Audits - How far do we have to go? How much detail? Supplier Quality Assurance and other Supplier Issues 12
D Showing Interrelationships - How Much Detail? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement Process Maps, Process Mapping and Turtle Diagrams 7
A Detail info on CMMI - Capability Maturity Model Integration for Software Software Quality Assurance 15
J FMEA Level of Detail - Is the registrar's auditor correct? FMEA and Control Plans 1
W Control Plan Content Requirements - Level of Detail FMEA and Control Plans 25
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
K When is Bioburden Testing Required? Other Medical Device Related Standards 3
G Is repeatability required for equipment calibration? General Measurement Device and Calibration Topics 10
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11

Similar threads

Top Bottom