When is a Work Instruction not necessary or required?

L

LexieB

#1
Hi all,

I'm new, so I should introduce myself really quick. I'm Lexie, and I'm coming from a few years of QA experience in medical device manufacturing and have now been recruited as Quality Director in the machine manufacturing industry. Part of my job at this new place is to obtain ISO certification, so of course the first thing I do is conduct my own mini-audit just to get a feel.

First issue: they have no work instructions for the major machines. At my previous place of employement, we had a work instruction for everything. When I brought up the idea of having WIs for the machines here, I got some eyebrow raises. They explained that 1) their customers are not asking for it, and 2) it's impossible because the machinists are hired on 10+ years of experience, and training is performed as an apprenticeship. According to the foreman, "I can tell whether they know the machines or not after watching them for 90 days." (Small family company, so I don't know if it makes a difference.)

Do you have any recommendations for handling this, and is a WI necessary for everything?

Thanks in advance!!
 
Elsmar Forum Sponsor
J

JaxQC

#2
Re: When isn't a work instruction necessary?

That’s great for the short term but what’s their plan for when the supervisor is hit by a bus and is no longer able to evaluate them. Humor aside, the point of the instructions is to retain the settings, setups and necessary info that will refresh or get someone where they need to be to make a quality product. Will the instructions take someone who doesn’t know which gas to turn on first how to weld. Not really. It’s intended to take a welder and let them know what they need to make a part correct the first time even if they never saw it before. Since you’re in machining, programs, cutting tools, tool positions, work offsets etc will help someone not have to reinvent the wheel every time. Their answer is a very short sighted view and personnel dependent.
 
#3
Re: When isn't a Work Instruction necessary?

First of all, welcome to the Cove!!!!! :bigwave:

Actually, I think you have more work instructions than you realize. As a machinist, I don't need a work instruction to tell me how to operate the equipment (I am not a machinist... this is just an illustration). I know how the equipment works, and what to do if there is a malfunction. Just like you probably don't need a work instruction to tell you how to start your car.

However, I do need some information relating to the product. You can't just tell me to "take some metal off". I need to know how much to take off where. That might mean a program, or maybe just a blueprint. In either case, that would be your work instruction. Just like I might need a map to show me how to get to someplace I have never been.
 
L

LexieB

#4
Re: When isn't a Work Instruction necessary?

First of all, welcome to the Cove!!!!! :bigwave:

Actually, I think you have more work instructions than you realize. As a machinist, I don't need a work instruction to tell me how to operate the equipment (I am not a machinist... this is just an illustration). I know how the equipment works, and what to do if there is a malfunction. Just like you probably don't need a work instruction to tell you how to start your car.

However, I do need some information relating to the product. You can't just tell me to "take some metal off". I need to know how much to take off where. That might mean a program, or maybe just a blueprint. In either case, that would be your work instruction. Just like I might need a map to show me how to get to someplace I have never been.
That makes a lot of sense! Thanks!
 

Colin

Quite Involved in Discussions
#6
Re: When isn't a Work Instruction necessary?

I liked the statement that was in a previous version of ISO 9001 (can't recall the version) where I think it said "provide work instructions where the absence of such could adversely affect quality"
 
Likes: db
#7
Re: When isn't a Work Instruction necessary?

I liked the statement that was in a previous version of ISO 9001 (can't recall the version) where I think it said "provide work instructions where the absence of such could adversely affect quality"
Actually that language is sorta still there in 4.2.1 d), except now it does not limit it to just work instructions.

---- added -----

But you are correct, in that the old language made it very clear.
 
Last edited by a moderator:

ScottK

Not out of the crisis
Staff member
Super Moderator
#8
Re: When isn't a Work Instruction necessary?

Hi Lexie. Welcome welcome.

Here's the shortest answer... ISO doesn't require work instructions.

Makes your job a lot easier, huh?

seriously, though. the need for work instructions is based on the organization. db makes a good point in that you probalby alreay have most of what you need... you just need to formalize it.

Let me give you an example of a situation I very recently had with our registrar:
Background: we make gas regulators, valves and pressure safety devices.
During the last ISO9001 surveillance the auditor noted that we don't have a formal work instruction for the assembly of a particular gas regulator series. My response was a polite "so what? We have several people who do this every day, the bill of materials is at hand, the parts can only go together one way and the order calls out the settings."
Well that wasn't good enough for him right then so we took a breather and he called his boss. He came back after lunch and said "you're right". In the end he wrote an observation that the test settings are not controlled formally... I agreed with that and we will make it better.

Now should we dowork instructions in the future? Maybe. It's a static process and if we get busy it will aid in training new people. But the way I see it is, at this time, there are higher priorities.

I think answering the question "when IS a work instruction necessary" is easier to answer - in my experience a work instruction is necessary when there is a problem with the process - like a step that keeps getting skipped - and you need something formal to train to. They are also handy if your turnover is high, or you need reference for jobs that don't come up that often.

:2cents:

Please stay with us and keep us updated on your progress!
 

Pancho

wikineer
Super Moderator
#9
Re: When isn't a Work Instruction necessary?

Knowledge in folks minds is "tacit", while knowledge that is written down is "explicit". Tacit knowledge is difficult to transmit and improve, and easy to lose. Explicit knowledge is all the opposite. Tacit knowledge may be sufficient to prevent an adverse effect on quality in the short term, but it is risky to rely on it.

Our preference is to turn as much of the tacit knowledge in our organization as possible into explicit knowledge. In other words, we try to document all work that matters into written instructions. One way that we have managed to do this is to write down or improve our documents (including work instructions) every time a problem comes up, or whenever we need to train someone. Most of our CAs involve at least tweaking the documentation to link to a description of the (possible) problem, and more often a modification in a WI.

Pancho
 

Stijloor

Staff member
Super Moderator
#10
Re: When isn't a Work Instruction necessary?

Knowledge in folks minds is "tacit", while knowledge that is written down is "explicit". Tacit knowledge is difficult to transmit and improve, and easy to lose. Explicit knowledge is all the opposite. Tacit knowledge may be sufficient to prevent an adverse effect on quality in the short term, but it is risky to rely on it.

Our preference is to turn as much of the tacit knowledge in our organization as possible into explicit knowledge. In other words, we try to document all work that matters into written instructions. One way that we have managed to do this is to write down or improve our documents (including work instructions) every time a problem comes up, or whenever we need to train someone. Most of our CAs involve at least tweaking the documentation to link to a description of the (possible) problem, and more often a modification in a WI.

Pancho
May I suggest that explicit can also mean electronically recorded sounds and images? For example, a simple video recording of a process or process steps can convey much more information and much clearer than a written document can.

A picture is worth a thousand words. :D

Stijloor.
 
Thread starter Similar threads Forum Replies Date
J One Work Instruction or Multiple Work Instructions (WI's) necessary Quality Management System (QMS) Manuals 13
T Is it necessary for every written procedure and work instruction to be controlled? Document Control Systems, Procedures, Forms and Templates 2
D Work Instruction Question ISO 13485:2016 - Medical Device Quality Management Systems 5
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
A Read instruction manual - What Graphic Symbol must I use? US Food and Drug Administration (FDA) 7
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
Mr Roo Work Instruction Authorization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
F Label work instruction - Medical Devices Manufacturing and Related Processes 1
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 15
S Root cause analysis - The system of developing a work instruction is not effective Problem Solving, Root Cause Fault and Failure Analysis 1
J Standard Work Instruction Languages (IATF 16949 8.5.1.2) IATF 16949 - Automotive Quality Systems Standard 8
E Safety work instruction if the equipment have the CE Marking and a Manual with safety instruction Various Other Specifications, Standards, and related Requirements 16
M EU Regulations or Standards for instruction for use (IFU ) EU Medical Device Regulations 3
S Manufacturing Work Instruction examples that include process pictures Manufacturing and Related Processes 3
L I need an example rework procedure/instruction for injected plastic parts Document Control Systems, Procedures, Forms and Templates 2
Q Product Instruction for Use Manual (IFU) - Obligation to list the standard used 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Example Work Instruction/Procedure for AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 4
W CPU BIST IEC 62304 - Embedded code has CPU instruction tests IEC 62304 - Medical Device Software Life Cycle Processes 2
M Standard work, standardized work instruction & work instruction: What are differences IATF 16949 - Automotive Quality Systems Standard 7
M Work Instruction Content or Sequence Changes and Operation Numbering Document Control Systems, Procedures, Forms and Templates 3
0 Safety Instruction Card and Safety Work Instruction Document Control Systems, Procedures, Forms and Templates 3
L TS16949 Work Instruction Requirements IATF 16949 - Automotive Quality Systems Standard 7
G SOP or Work Instruction for PFMEA? FMEA and Control Plans 5
Z Internal Memo used to document work instruction Document Control Systems, Procedures, Forms and Templates 2
T Handling of Obsolete Material Work Instruction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Mention "according to Work Instruction" in Control Plan FMEA and Control Plans 3
alonFAI SMI (Solder Paste Inspection ) Inline Work Instruction (Procedure) Manufacturing and Related Processes 3
G Work Instruction Performance Measures Misc. Quality Assurance and Business Systems Related Topics 3
M ISO 9001 Work Instruction Structure Document Control Systems, Procedures, Forms and Templates 1
W Control of Document - Working Instruction and Checklist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Steps to Complete Quality Control Plans and Work Instruction Manufacturing and Related Processes 4
A Should I call this ?Blank Template? a Work Instruction? Document Control Systems, Procedures, Forms and Templates 11
Q Referencing a Specification in a Work Instruction as a ?Guidance Document? ISO 13485:2016 - Medical Device Quality Management Systems 1
C SOP Work Instruction (Job Card) Template Revisions question Document Control Systems, Procedures, Forms and Templates 6
K Intended Use wording: What is suitable for the instruction manual? EU Medical Device Regulations 4
A Definition Technical Work Instruction vs. Method Statement - Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
M Orthopedic IFU ( Instruction For Use ) EU Medical Device Regulations 3
J Control of equipment instruction manuals ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H Writing a Product Label Inspection Work Instruction Manufacturing and Related Processes 2
I Document Control - Instruction Manuals and Service Manuals General Measurement Device and Calibration Topics 2
C SS-EN ISO13485 Work Instruction Requirements for Dentures ISO 13485:2016 - Medical Device Quality Management Systems 2
I Work Instruction for Validation of Packaging to EN ISO 11607-2 Requirements Document Control Systems, Procedures, Forms and Templates 3
M Looking for a Powder Coating Process Instruction Manufacturing and Related Processes 3
J Setting up Performance Review Instruction Phrases in my Company Human Factors and Ergonomics in Engineering 11
W FDA Labeling Requirements - Instruction for Use Content 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L ISO 17021:2011 - The Application of Annex A - Work Instruction Details General Auditing Discussions 9
T AS9100C Work Instruction Clarification - How detailed should a Work Instruction be? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
B Work Instruction Application (Software for Document Control) Quality Assurance and Compliance Software Tools and Solutions 2
6 Instruction Manual for the production of Deionized Water Manufacturing and Related Processes 2
M Procedure & Work Instruction Flow Charting vs. Turtle Diagrams AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7

Similar threads

Top Bottom