Work Instruction vs. Reference Only document - Computer software use instructions

E

eohara - 2008

#1
Hi,

I know I may start a firestorm of people who hate "reference only" documents, but let me ask if this case might be ok......

We have Procedures for our Quality System and Work Instructions for our Mfg tasks (Asm, Shipping, Service). My question is regarding SPECIFIC indirect support job tasks, and if they need work instructions.

For example, our customer service rep was leaving, so she created a big list of uncontrolled instructions for her replacement - how to enter orders, how to invoice, etc - basically, how to use our computer software to perform the tasks. The new person ended up using these to learn, but modifying them to fit the way she liked to do the job. I don't think these need to be controlled. Can these remain "Reference Only"? I see them more as job aids than work instructions. Also, since we're a small company, if I start making everyone document work instructions, the author and the trainee will end up being the same person.

Comments?

Thanks in advance for the feedback.

Emily
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Work Instruction vs. Reference Only document

Hi,

I know I may start a firestorm of people who hate "reference only" documents, but let me ask if this case might be ok......

We have Procedures for our Quality System and Work Instructions for our Mfg tasks (Asm, Shipping, Service). My question is regarding SPECIFIC indirect support job tasks, and if they need work instructions.

For example, our customer service rep was leaving, so she created a big list of uncontrolled instructions for her replacement - how to enter orders, how to invoice, etc - basically, how to use our computer software to perform the tasks. The new person ended up using these to learn, but modifying them to fit the way she liked to do the job. I don't think these need to be controlled. Can these remain "Reference Only"? I see them more as job aids than work instructions. Also, since we're a small company, if I start making everyone document work instructions, the author and the trainee will end up being the same person.

Comments?

Thanks in advance for the feedback.

Emily
Emily,

When you work for a small organization, how important is it that experience is maintained? (Preservation of knowledge). In your example, the instructions should have been developed long before the person left. It's all part of mitigating risk (within reason of course).

As far as documents are concerned, aren't they all "for reference only?";)
Any time you look at a document, aren't we "referring?"

I know, I may be splitting hairs here. :)

In the end, do what makes sense for your organization but keep it simple, practical, and easy to maintain.

I always say about a document: "If you keep it; control it!"

Good Luck.

Stijloor.
 

Randy

Super Moderator
#3
Re: Work Instruction vs. Reference Only document

If it has to be referenced, it isn't, it's an operational document. Just a hint;)
 
C

CliffK

#4
Re: Work Instruction vs. Reference Only document

Having these documents available becomes more important when only one person knows how to do the job - often the case in a small company.

The way to make sure the documents remain available is to control them.

Your control method does not have to be complicated. The hardest part will be thinking of a simple way to handle them.

:topic:Did you ever notice how easy it is to think of a complicated way to do things, and how hard it is to think of a truly simple way?
 

Wes Bucey

Quite Involved in Discussions
#5
Re: Work Instruction vs. Reference Only document

I see two issues.
  1. Operating instructions describe how a system works when certain inputs are entered. This is pretty much like saying the light will [probably] go on when one flips the switch. Sounds to me like the first operator combined this information with the following information (work instructions) and needlessly muddied the water.
  2. Work instructions describe when and under what conditions a worker should flip the switch. This is pretty much like saying, "Flip the switch to on when you start the shift."
Neither of those instructions goes into a lengthy discourse about the nature of electricity, the type of lamp used, the current and voltage, or even preventive maintenance of cleaning and changing bulbs in the lamp (since the need for that information may be for a different employee function.)

The biggest value of a controlled work instruction which is followed by each and every worker performing the task is that it provides a baseline for determining root causes of nonconformance AND simultaneously provides a baseline for potential improvement of the methods used in the process.

When internal auditors perform an audit, they try to determine if a system or process is being performed according to plan. If not, does the change from the plan result in a nonconformance of output? If there is no nonconformance of output or (especially) if there is an improvement in output as a result of the change from the plan, is this an improvement which should be documented and the plan modified to adopt it as the new plan?
 
S

spacemanR

#6
Re: Work Instruction vs. Reference Only document

Emily,
in my opinon,if one oprocess operation is not enough simple for the process owner,the WI need to be devopled ,of course the WI need to be controlled,or the concerned person will be guided wrong.
 
U

Umang Vidyarthi

#7
Re: Work Instruction vs. Reference Only document

Hi,

I know I may start a firestorm of people who hate "reference only" documents, but let me ask if this case might be ok......

We have Procedures for our Quality System and Work Instructions for our Mfg tasks (Asm, Shipping, Service). My question is regarding SPECIFIC indirect support job tasks, and if they need work instructions.

For example, our customer service rep was leaving, so she created a big list of uncontrolled instructions for her replacement - how to enter orders, how to invoice, etc - basically, how to use our computer software to perform the tasks. The new person ended up using these to learn, but modifying them to fit the way she liked to do the job. I don't think these need to be controlled. Can these remain "Reference Only"? I see them more as job aids than work instructions. Also, since we're a small company, if I start making everyone document work instructions, the author and the trainee will end up being the same person.

Comments?

Thanks in advance for the feedback.

Emily
Hello Emily,

The 'instructions' given by the out going person can also be controlled by stamping it 'UNCONTROLLED' (as is being done on Engg.drawings), and the new incumbent can revise and endorse it by showing 'Rev.- 01'.

Hope this helps

Umang :bigwave:
 

Jim Wynne

Staff member
Admin
#8
Re: Work Instruction vs. Reference Only document

Hello Emily,

The 'instructions' given by the out going person can also be controlled by stamping it 'UNCONTROLLED' (as is being done on Engg.drawings), and the new incumbent can revise and endorse it by showing 'Rev.- 01'.

Hope this helps

Umang :bigwave:
And we have always been at war with Eurasia. How can something that is marked "uncontrolled" be controlled? I think it's a fairly simple matter. As Wes suggested, the "operational" part of it should be extracted and left uncontrolled, and the instructions relative to running the process should either be controlled or gotten rid of. A decision needs to be made about controlling the process. If the process needs to be controlled, the documentation does too.
 

SteelMaiden

Super Moderator
Super Moderator
#9
Re: Work Instruction vs. Reference Only document

Personally, if the job is so that you need pages of instructions, and nobody (one person) could teach you how to do the job, you should probably create either work instructions, or a training document (same thing imho) so you do not lose bits and pieces through the cracks only to wonder at some later date - What Happened?
 
E

eohara - 2008

#10
Re: Work Instruction vs. Reference Only document

THANK YOU EVERYONE! I think I knew I had to control them, but I didn't want to overcomplicate things. Everyone gave great feedback and ideas, and my favorite was this quote below:

"Did you ever notice how easy it is to think of a complicated way to do things, and how hard it is to think of a truly simple way?"


That will be my task!

Thanks again

Emily
 
Thread starter Similar threads Forum Replies Date
A Changes to QRI (Quick Reference Instruction)? What I can or cannot change ISO 13485:2016 - Medical Device Quality Management Systems 2
M How do you reference a WI (Work Instruction) to a procedure? Document Control Systems, Procedures, Forms and Templates 16
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