Work Instructions - Process Control and a SOR (Set-up, Operate, and Reaction) Plan

A

AAguado

#1
#1
Well, I'm not sure :$ in which Room I should place this info: Marc, pls put it in the best fit place...

A few days ago, I was browsing at "Procedures" room and I was trying to find out any Work instruction example: nothing avaliable.
So, I'm attaching an example of my work instructions used by Operators in a Computer central agency.

Here's the explanation (DiviRep is the name of this product):
*Flux-D: workflow diagram, showing also: responsabilities, control process parameter and current specification (w/tolerances if apply).

*FMEA-D: FMEA starting from control process parameter (from Flux) to detect possible failures and consecuences.

*5w+1H_D: the well known methodology to deploy a reaction/prevention plan.

One of the main purpouses to writte down this very "long" wk instructions is for disminish Operators excessive dependence in Supervisors (FYI this area works 24/7), and to have a very formal documentation for trainning new Operators.

PS: Sorry for my English grammar horrors (English isn't my mother tongue...).
 

Attachments

SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
E Wall

E Wall

Just Me!
Super Moderator
#2
#2
Translation

After reviewing the documents provided, I find that I cannot offer an opinion because the documents are not in English. Please be patient, you may have to wait a few days for a response.

Can anyone else help out?
 
A

AAguado

#3
#3
Brief explanation

Ok.
I'm attaching a -very- brief explanation/translation:bonk: of my previous post: I hope it'd be helpful:smokin: .

Plz, let me know any comments or feedback.
 

Attachments

E Wall

E Wall

Just Me!
Super Moderator
#4
#4
I like it

AAguado - This looks like a cross between a process control and a SOR (Set-up, Operate, and Reaction) plan. Very effective to communicate with first line employees for thier use and is a helpful auditing tool as well.

What I couldn't tell from the limited amount of translations is: Are there references included for any required records or reporting of information? If not you may consider including them along with references to higher level process documents if applicable.

Best Regards, Eileen
 
A

AAguado

#5
#5
Eileen,
Thx for your comments (I appreciate it :bigwave: ).

That was one of the main concerns of Top Managment here: is there an effective ending of work instructions? :confused: how do you know where it ends? is there any link with those currently mapped products (an output that might feed another product)? :frust:

Well, trackability it's how we distiguish if the "product" was effective performed :smokin: . I mean, the output (a file, a report) will lead us to determine if we must segregate and rework or approve for next stage (note: most of the products, are sub-products or inputs for another process).

Thx again and I'll be carefully checkin' out your advice.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
O Work Instructions vs. Process Control Plans - No Substitutions? TS16949 - 7.5.1.2 Document Control Systems, Procedures, Forms and Templates 10
R Design Control Gating Process - Seeking work instructions and discussion Design and Development of Products and Processes 20
S Process Control - The Requirement for listing references in Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Manufacturing Process Work Instructions - Format Manufacturing and Related Processes 4
A Process Changes, but Work Instructions/Process Maps are not updated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Machine Shop Process Instructions (Traveler) question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R Work Instructions versus Process Flow Charts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Process Instructions via BOM for Subcontractor? (PCB Population) Manufacturing and Related Processes 2
N What is the difference between Process, Procedure and Work Instructions Document Control Systems, Procedures, Forms and Templates 2
S Template for Operating Instructions for a Lamination Process Document Control Systems, Procedures, Forms and Templates 12
Q Training Matrix - Job Class vs. Process Instructions - ISO 13485 Training - Internal, External, Online and Distance Learning 4
M What is the difference between process documents vs. Work Instructions? Document Control Systems, Procedures, Forms and Templates 2
S Manufacturing Process Work Instructions vs. Work Procedures - Differences? Document Control Systems, Procedures, Forms and Templates 10
R Talsico Process Picture Map software to write their procedures / work instructions? Quality Assurance and Compliance Software Tools and Solutions 2
L 4.9.1 Process Monitoring & Operator Instructions QS-9000 - American Automotive Manufacturers Standard 1
T Design Traceability - Labelling / Instructions for Use ISO 13485:2016 - Medical Device Quality Management Systems 5
S Instructions for use multiple manufacturing locations ISO 13485:2016 - Medical Device Quality Management Systems 0
T Different Formats for SOPs/Work Instructions? Document Control Systems, Procedures, Forms and Templates 5
dgrainger Informational EC - Medical devices – online manuals replacing paper instructions - Feedback period: 27 April 2021 - 25 May 2021 EU Medical Device Regulations 0
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
U Intended Users in IFU (Instructions for Use) EU Medical Device Regulations 5
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
C Work Instructions; Controlled/Uncontrolled? Document Control Systems, Procedures, Forms and Templates 5
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
L MDR - Information in the instructions for use - clause 23.4.(z) EU Medical Device Regulations 4
S ISO 18223-2 Temperature symbol in the Legend table in the Instructions for Use Other ISO and International Standards and European Regulations 4
S Providing IFU (Instructions for Use) in multiple languages EU Medical Device Regulations 0
M Informational The USFDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
Z IFU (Instructions for Use) Symbol - 7010:M002 - can it be in black? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Document levels and approval requirements for lower level documents like work instructions, forms etc. Document Control Systems, Procedures, Forms and Templates 18
N Electronic Instructions for use (eIFU) EU Medical Device Regulations 2
Marc Elsmar Xenforo Software Instructions #2 - 9/2018 Elsmar Xenforo Forum Software Instructions and Help 0
Marc Elsmar Xenforo Software Instructions #1 - 9/2018 Elsmar Xenforo Forum Software Instructions and Help 0
M Batch record supersedes all other instructions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H SPC Work Instructions (WI) Statistical Analysis Tools, Techniques and SPC 2
S Are 2 Hard Copies of Procedures and Instructions Required? ISO 13485:2016 - Medical Device Quality Management Systems 6
K IATF 16949 Cl. 8.5.1.2 - Requirements of Work Instructions and Documents IATF 16949 - Automotive Quality Systems Standard 2
J Work Instructions - We have approx 1,000 work instructions from over the years Document Control Systems, Procedures, Forms and Templates 8
Ajit Basrur Incoming Inspection for Instructions for Use (IFU) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Product Instructions (IFU) - Placement Requirements - ISO 13485:2003/2016 Other ISO and International Standards and European Regulations 2
D 207/2012 Update for MDR (?) - Instructions for Use (IFU) EU Medical Device Regulations 9
R How to Control Videos as part of the QMS Documented Procedures and Instructions Document Control Systems, Procedures, Forms and Templates 2
D eQMS/ERP System Admin Work Instructions - Where do they fit? Misc. Quality Assurance and Business Systems Related Topics 5
R ISO 50001 - Manual and instructions Sustainability, Green Initiatives and Ecology 8
C Following Order of Work Instructions ISO 13485:2016 - Medical Device Quality Management Systems 23

Similar threads

Top Bottom