The content of Work Instructions

S

s_warin

#1
The contents of work instruction should describe critical activities. Details which do not give more control of the activity should be avoided.
How to justify which is critical activities?
What is the criteria?
Why details should be avoided?:(

(4.6.2 Contents: ISO/TR 10013:2001)
 
Elsmar Forum Sponsor
#2
Ok, I'll start off...

First I'd have a look at 9001:2000 4.2.1 note 2.

I suppose an activity would be considered critical if a failure to perform it correctly means that the end product suffers?

That, in turn, puts the focus on the skill level of the operator and the compexity of the operation.

Opinions anyone?

/Claes
 
#3
Work Instruction Content

Also don't forget Note 2 of 4.2.1, dealing with what to consider when looking at the detail of the work instruction.
 
M

M Greenaway

#4
Again this is something only you can answer. Dont worry that an auditor will pick you up for not having a work instruction, or not having sufficient detail in a work instruction - it wont happen.

Conducting an FMEA might well highlight areas that need control, which you may target through additional work instructions if so desired.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#5
We've discussed this in another recent thread. Bottom line: Work with the people who will be using the WI to determine what level of detail is needed to do the task effectively and efficiently. Consider the users' education, skill level, familiarity with the job, how often it is performed (might people forget things if it is an infrequently done task?), training, who will be the "backup" task performer if/when the primary task performer is not at work and what might their needs be, the criticality of the task, etc. As is often said here in the Cove, write it so that it works for your people, not for the auditor. Don't get paralyzed by analysis -- try something and revisit it later to see if it is working and adequate, if not revise it as needed (PDCA!). JMO as always.
 
T

Trakman

#6
Hello s_warin,

A few thoughts...

give due consideration to Standing Operating Procedures - for example, SOP1 describes inserting light bulb
SOP2 describes testing light bulb
SOP3 describes removing old light bulb

So the "Real" procedure might state: SOP3 --> SOP1 --> SOP2.

Next time when there is no old bulb in the socket, the "real" procedure is SOP1 --> SOP2.
This avoids having to re-write the entire procedure.

Of course the example would really apply to the more complicated common procedures that need to be performed.

The real question is, What do your employees need to know to get the procedure done? Document it, or train them to do it in their sleep, and toss (put away) the procedure.

Can you verify that the result is correct based and meeting your expectations (spc, inspections, etc..) with no written procedure? If yes, then the procedure can stay absent. Is the procedure being performed with the same problems over and over? Maybe put reminders near the machine. ("Keep machine clear of chips to prevent scratching...") Keep in mind that a "procedure" also can be:
-a video of the work example
-an internal web page with instructions
-a sample with numbers on the parts indicating the order of work
-a sample in some level of partial assembly secured to the wall or a board with numbers indicating order (think of taking a hamburger apart and stapling each item on the wall in order of assembly with arrows!... this also gets beyond language barriers)
-pictures in order (e.g. think of teaching a child to do chores)

Keep it simple and clear. Include the details that always get forgotten that matter.

:smokin:
 
R

RICKG111

#7
Re: What do you think about the content of Work Instruction?

Very true in my own experience as well. Concentrate on those aspects, parameters (specs) that are the process/manufacturing variables. These will dictate the level of instructional control you may need to write. Provide detail ... where it is needed to produce uniformly. The WI could just say, "make it to drawing XXX" or may need level(s) of WI to complete. A skilled machinist might only need the base drawing, while lesser trained/skilled employees would need more detailed instructions.
 
S

Sequence_Barry

#8
Great answer Mike S. As we have worked with customers over the years we have learned that the only hard and fast rule is "know your audience." This encompasses skill level, frequency of build, complexity, regulatory requirements, etc.

Regarding leaving out detail, while unnecessary information should be avoided, we have encountered companies that write only very general, high-level instructions to avoid issues of not following the work instructions when being audited. We typically find this practice in organizations that are just trying to skate by as opposed to organizations that are really focused on lean and quality.
 
Thread starter Similar threads Forum Replies Date
V Manufacturing Work Instructions and Work Instruction Content Manufacturing and Related Processes 4
S Manufacturing Instructions and Forms for our Products - Question on Content Document Control Systems, Procedures, Forms and Templates 9
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
F Calibration certificate content - Average Value and True Value ISO 17025 related Discussions 6
Raffy ISO 14001 9.2.2 Internal Audit Programme Content Internal Auditing 9
F Control of medical device IFU content Other Medical Device and Orthopedic Related Topics 3
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
L Label Content Requirements under MDR regulation EU Medical Device Regulations 5
dgrainger MHRA - Creation of new UK Responsible Person section with added content. Medical Device and FDA Regulations and Standards News 0
L Content of Declaration of conformity (MDR) EU Medical Device Regulations 1
E Calibration Certificate Content Requirements General Measurement Device and Calibration Topics 3
G ISO 9001 - 9.3.1 Management Review - Content and Frequency Management Review Meetings and related Processes 12
Dean Bell QMS Content for one-man consultancy Consultants and Consulting 19
I Environmental Policy Content - ISO 14001 Clause 5.2 ISO 14001:2015 Specific Discussions 2
F Organising IQ, OQ and PQ content in a "smart" way Qualification and Validation (including 21 CFR Part 11) 3
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M Informational EU – MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers Medical Device and FDA Regulations and Standards News 0
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
M FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission Medical Device and FDA Regulations and Standards News 1
G Regulatory requirements for secondary packages in terms of label content Other Medical Device Regulations World-Wide 2
M Is referenced content sufficient to meet record content requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Corrections and Removals - Fiber Content in our textile products was incorrect Other US Medical Device Regulations 1
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
H Numbering for documents with same content but different language ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 9001:2015 Transition Quality Manual Update - Redundant Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Software for Medical Devices - Requirements Content for compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
V Periodic Audit Trail Review - Scope, Content & Frequency Qualification and Validation (including 21 CFR Part 11) 10
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Work Instruction Content or Sequence Changes and Operation Numbering Document Control Systems, Procedures, Forms and Templates 3
C AS9102 FAIR Form 1 Content Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
T ISO 62304 - Software requirements content IEC 62304 - Medical Device Software Life Cycle Processes 3
H Cause analysis for an Audit Finding - Purchasing Procedure Content ISO 13485:2016 - Medical Device Quality Management Systems 9
Oscar Wang Question on the Content of an Abbreviated 510(k) US Food and Drug Administration (FDA) 1
Q Scope in procedure and content for 7.6 Monitoring and Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A API (American Petroleum Institute) Design Package Content Requirements Oil and Gas Industry Standards and Regulations 1
S Required PFMEA Content - Final QC Inspection FMEA and Control Plans 7
R Inconsistent Form Content including User Changes Document Control Systems, Procedures, Forms and Templates 3
B External Label Content of multi-device (sterile and nonsterile) EU Medical Device Regulations 2
J Document Control Features (Document Content Requirements) and 21 CFR 820.40 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Scope content of TS 16949 certificate under Rules 4 IATF 16949 - Automotive Quality Systems Standard 6
D Class II Disposable Medical Device Label Content Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Change in wording, but not content - Special 510k? Other US Medical Device Regulations 2
D ESD Policy Content Best Practices Manufacturing and Related Processes 8
S Glove Protein Content in μg/dm2 to μg/g and Powder Amount mg/dm2 to mg/glove Other Medical Device Regulations World-Wide 4
K FMEA and Control Plan Header Content FMEA and Control Plans 6
I Content to be included or excluded in Design Control Meeting Minutes ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom