SBS - The best value in QMS software

Same format for WI (Work Instruction) and Procedures?

#21
It´s clear what Procedures should contain (what, when, who)
and format is Objective,Scope, responsibles,references, etc,

In the case of WI what is the format?
it is the same or just plain instructions, let´s say

e.j. For calibrating a device

1 take the device
2 clean it
3 Take the manometer....
etc

Excluding how the procedures begin with?
------------------------
Other 2 points
Will be recommended to include the Wi into the procedure document
thus avoiding to create a lot of WI´s?
is there an iso rule for this?
-----------------------------------
I have seen some WI but the file name is e.j. "Procedure for managing documents"
and they begin with Objective, scope,purposes,etc.
why that?
I suppose that the difference it´s its contents
Procedures= what, who ,when
WI=how to do it, with no other text
what is your point of view?
--------------------------



Hope somone can help me

Lot of thanks
Tvillan:
The advise you've had here is great, if you feel you must stay with that kind of structure. I believe that this level of formality is one of the reasons that no one likes the quality system documentation - because to use that format makes documentation into a bureacracy. There are threads recently posted which are asking for help to 'energize' people. I'd wager a large part of the problem is the 'heavyweight' formality of the documentation they were told to use. Most of these 'formal' documents started in heavily regulated/military style requirements and have been passed on through the 'ISO' world. You don't have to do it that way.......

Work instructions are best made as pictures with little or no words - for an example you only have to look how effective the emergency instructions are on a plane.(Yes. I know we hope we never have to use them........:rolleyes:)

Procedures can be introduced 'This is the way we do.........XXXX'. If you are having to make long lists of definitions etc., then who are you writing them for? The people who do the job should help create the documentation. I have helped document systems using both formats and I have seen which style people prefer.

In the USA everyone talks about the 'KISS' principle - you can use this too.....

(I think it means Keep It Short and Sweet..............:lmao::lmao:)
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#22
Tvillan:
The advise you've had here is great, if you feel you must stay with that kind of structure. I believe that this level of formality is one of the reasons that no one likes the quality system documentation....
Good point. I'm a flow chart proponent for system and departmental procedures. The best ones are linear with inputs and outputs on either side. They have a lot more details than when I first started using them in the late 1980's.

Work Instructions are another matter. I've seen lots of formats for work instructions. For some years now electronic pictures has made for some very nice formats with visuals
 

BradM

Staff member
Admin
#23
Tvillan:
The advise you've had here is great, if you feel you must stay with that kind of structure. I believe that this level of formality is one of the reasons that no one likes the quality system documentation - because to use that format makes documentation into a bureacracy. There are threads recently posted which are asking for help to 'energize' people. I'd wager a large part of the problem is the 'heavyweight' formality of the documentation they were told to use. Most of these 'formal' documents started in heavily regulated/military style requirements and have been passed on through the 'ISO' world. You don't have to do it that way.......
Andy, this is such a well-worded paragraph, I just wanted to repeat it again. The only thing that would have made it better is if I had stated it!:tg:

Let's pick Taco Bell. Is this organization not concerned with consistency and standardization? By all means. Observe their posters/ pictures on the wall inside the work area (sometimes not easy to see from the register; but look for them and you'll see them). They are simple, clear, and easy to follow. They are written for their workers to follow. Some just have pictures, some are diagrams, and a few are statements of sorts. All are simple, easy to follow and very clear. Then, management concerns themselves with training and supporting the policies.

Know thy audience.
 
#24
Why, Brad, thank you very much!:bighug:

I'm a Taco Bell afficionado myself and use that analogy for documentation (or McDonald's) as part of related discussions when running a class! (and I have teenagers, so we have to 'do' Taco Bell sometimes!!)
:thanks:
 
Thread starter Similar threads Forum Replies Date
Q Managing Internal/External RNC and Complaints in same Format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Are you allowed to reuse the same asset number if the device was replaced? General Measurement Device and Calibration Topics 10
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
Scanton Double Major for the same infraction? IATF 16949 - Automotive Quality Systems Standard 11
G Same parts but new customer - What will the auditor ask me? IATF 16949 - Automotive Quality Systems Standard 2
K 510K new manufacturer but same components Other US Medical Device Regulations 6
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
G Same intended use devices - Technical file EU Medical Device Regulations 5
K More than one importer for the same device 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
K Validation of new machine (second machine of the same type) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
M MSDS process audit - Can any one give idea for checklist of the same Occupational Health & Safety Management Standards 14
L PMA and Non-PMA parts in same finished goods area? Federal Aviation Administration (FAA) Standards and Requirements 1
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
C Failure nets - Same level effects FMEA and Control Plans 0
C Subsidiaries; same/different Quality Policies? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
qualprod Add new action plans in CA, while waiting effectiveness - Same problem reappears ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
S Multiple Authorized Reps in the EU for the same device? EU Medical Device Regulations 3
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Help me to decide which test to use - If each proportion belongs to the same population Using Minitab Software 7
qualprod Write down same nonconformity in several processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J UDI Requirements - Products that all fall under the same family 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Is an Annual Layout Inspection the same as an Annual Re-validation? Internal Auditing 1
B AS9100 Multiple Distributor warehousing locations under same Company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
GStough Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate? Registrars and Notified Bodies 7
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
I Corrective Action Tracking for Product and Process in the same system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
MrTetris Informational Risk Register - Same hazardous situation, different severity of harms ISO 14971 - Medical Device Risk Management 7
K Is minimum repair or replace guarantee period for medical devices in EU the same as consumer guarantee law of 2 years? EU Medical Device Regulations 5
D IATF 16949: Do we have too many processes? Are they all the same? Registrars and Notified Bodies 7
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
qualprod ISO 9001 - Cl 6.1 and 9.3 and 10 - Opportunities for Improvement the same? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P Is throughput yield the same as FPY or FTY? Rolled Throughput Yield Manufacturing and Related Processes 3
J Is a stable process also normal at the same time? Manufacturing and Related Processes 7
qualprod Transition and recertification at the same time? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Legal requirement for same indications as in Country of Origin Other Medical Device Regulations World-Wide 4
H Numbering for documents with same content but different language ISO 13485:2016 - Medical Device Quality Management Systems 4
D CE Mark with same NB (Notified Body)? CE Marking (Conformité Européene) / CB Scheme 4
A Why I get a different kind of regression equation when I do the same data in a differ Using Minitab Software 7
B PMCF study plan is same to clinical investigation plan? EU Medical Device Regulations 3
W Is sharing resources treated same way as remote function? IATF 16949 - Automotive Quality Systems Standard 1
K Is an annual "audit schedule" the same thing as an audit scope/ audit plan? Internal Auditing 8
Jane's You may or may not have the same person managing Operations and QA ISO 13485:2016 - Medical Device Quality Management Systems 18
S Is it advisable to do MDSAP and ISO 13485:2016 at the same time? ISO 13485:2016 - Medical Device Quality Management Systems 11
Q Risk Analysis - Same Risk Treatment for Context and Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Gantt Chart / Time Tracker in Excel - Combining Tasks on the Same Line Excel .xls Spreadsheet Templates and Tools 2

Similar threads

Top Bottom