Defining what a Posted Work Instruction is



I have organizational responsibility for Document and Data Control. Our Production Manager wants the authority to "post" information in the production area. He has done so on many occasions. I'm concerned that some of these postings are "work instructions". In fact, the PM agrees that some could be defined as such. Some are even taken directly from documented SOPs! However, they are not "controlled" with revision leves/dates, nor have they been subjected to an "approval" process.

Two questions: 1) How does your organization define a Posted Work Instruction, and 2) Do you interpret the Standard as providing an organization with the discretion and/or lattitude to authorize an individual, such as a Production Manager, to post work instructions as described?
Elsmar Forum Sponsor

M Greenaway

There is nothing in the standard to say a PM cant issue documents (the standard is not that specific), but like you say they must be issued under the controlled conditions required by ISO9001. The PM can operate this control himself.
Yes, they own the written procedures

Absolutley.... Our managers are the owners of the work instructions concerning their departments. As long as they follow our procedure for control of documents, I'm all for it.


barb butrym

Quite Involved in Discussions
local control

I typically recommend a part of doc control I call "local control' that allows excerpts, blow ups of an area of a drawing or diagram and posted memos, color coded assy stuff, WI or the be controlled by the area supervisor etc..... i usually design a representative stamp or label for it that the controller/issuer fills the doc # and rev it was taken from ( or correct to, so if a rev changes and the info doesn't a detailed new color coded/blow up example doesn't have to be generated just a new label), who and when issued, exp date if required (not typically...but some times) and so on. detailed WI get a little closer to the normal doc control procedure with revisions. the stamp is designed for each company based on what they is the verbage/rules

Laura - 2003

Work instructions are the responsibility of the originator as is the control.

It is up to the originator to ensure their work instructions are controlled in accordance with the data and document control procedure.

Mike S.

Happy to be Alive
Trusted Information Resource
I agree that a PM or area manager, etc. can post work instructions IF they maintain the required doc. control as per your procedures. This is perhaps the ideal situation as well. However, I have found that, especially in the infancy (maybe through the adolesence!) of a QMS often times these managers will "forget" or not follow the doc. control procedures (maybe they're too busy with the "important stuff"), resulting in the predictable chaos of poor doc. control not to mention audit troubles. They often like the "freedom" /"authority" of doing it but sometimes can't play by the rules.

One option is to train them well in the proper doc. control procedures and tell them they can do it on their own as long as they play by the rules. Then, formally or informally, audit them often until you are confident they pass muster. If they drop the ball, you have two choices: Report them to their superior if you think that'll do any good (in some cultures yes, in others, no). Or, take it from them, forcing them to go through you for issuance/change control etc. More work for you, unfortunatley, but perhaps less than dealing with the chaos when they don't behave. Then, perhaps later, when the QMS is more ingrained and mature (one hopes!) maybe they can take it back and do it right.

Just one of those many cases where sometimes the ideal doesn't work in the real world, unfortunately. JMHO.

Mike S.


W/I, Notes etc.

Our policy is:

Anything related to "how you do your job" has to be controlled.

Below is in my W/I.

"Any individual page(s) removed from the document and placed at a site away from the controlled document shall be kept intact and controlled by the process number and revision. The person posting will document page(s) posted and their location on the front page of the controlled document. This will alert Document Control to update/ remove posted copies when changing over documents. The removed copies will be forwarded to the appropriate Engineer and the Engineer will update posted copy as deemed necessary and annotate on coversheet."

Michelle<who is the doc tech.
Thread starter Similar threads Forum Replies Date
S Defining special characteristics beyond customer drawing FMEA and Control Plans 11
PQ Systems Defining Quality with Specifications Using SQCpack Software 0
K Defining risk control measures IEC 62304 - Medical Device Software Life Cycle Processes 14
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Defining staff competence - Small mechanical workshop Occupational Health & Safety Management Standards 20
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 3
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
K Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
C AS9100 rev D 8.5.1 c 2 - Defining the Machine in-process frequency per ANSI/ASQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
V Defining Safety Precautions for Category 4,5 Molecules Occupational Health & Safety Management Standards 2
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
T Defining Major vs. Minor Changes to Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
GStough Adequately Defining Which Suppliers to Audit and Frequency Supplier Quality Assurance and other Supplier Issues 8
E Quality Techucuan (Technician) in Electronics - Defining Postion Requirements Career and Occupation Discussions 4
moritz Defining a good Scope for Critical SOPs ISO 13485:2016 - Medical Device Quality Management Systems 7
T Standards for defining audible alarms/warnings for OR instruments IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Defining Critical Vs. Non-Critical Suppliers/Service Providers (API Q1, 9th. Ed.) Oil and Gas Industry Standards and Regulations 2
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Defining Sub-Disciplines for Chemical Testing Laboratory Employee Proficiency Testing General Measurement Device and Calibration Topics 1
T Defining Nonconformances in a Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Defining Reliability and Confidence Levels Reliability Analysis - Predictions, Testing and Standards 8
J Defining Martial Arts and Gymnastics Statistical Techniques Statistical Analysis Tools, Techniques and SPC 4
V Defining the criteria for equipment to be qualified or requalified Qualification and Validation (including 21 CFR Part 11) 2
R Need help on defining scope for Design Verification File for Class III IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Defining CCP (Critical Control Points) in a Rice Mill Plant Food Safety - ISO 22000, HACCP (21 CFR 120) 9
S Process Map and defining KPIs Misc. Quality Assurance and Business Systems Related Topics 5
5 Major Nonconformance for not "clearly" defining the "device lifetime" ISO 13485:2016 - Medical Device Quality Management Systems 2
E Defining the lifetime of an Implantable Medical Device Other Medical Device and Orthopedic Related Topics 5
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Defining Post Mold Cure Ramp-Down Temperature Manufacturing and Related Processes 2
K Audit Nonconformity on Defining 'Outsourced' Infrastructure Maintenance Quality Manager and Management Related Issues 21
G Points to consider while defining the Quality Policy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Developing Documentation and Defining Processes as Subcontractor IATF 16949 - Automotive Quality Systems Standard 6
C Defining ISO 9001:2008 Scope for a Sterilization Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Defining Skilled vs. Semi-Skilled vs. Unskilled Labor Manufacturing and Related Processes 1
I Defining the scope for ISO 9001 Registration - Software, Hardware and Customer Care ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Product Specification vs. Information Defining Product - The differences? IATF 16949 - Automotive Quality Systems Standard 6
R Defining Interaction of Processes in a Software Company Software Quality Assurance 3
N Where to begin defining and monitoring Quality Metrics in a Machine Shop Manufacturing and Related Processes 9
A Testing Process Audit - Defining a Process Compliance Mechanism Software Quality Assurance 2
R Defining the type of Applied Part - Metal Probe (Applied Part) employs Water Cooling IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Defining Security Interfaces for Scope for ISMS - Need help IEC 27001 - Information Security Management Systems (ISMS) 10

Similar threads

Top Bottom