PFD (Process Flow Diagram) approach. Setup details as part of PFD?

#1
So coming from different companies where we mainly assembly products, it has been very easy in the past to write PFDs, most of the operations where related for screw assembly, apply coatings, programing PCB's, soldering harnesses, cutting wires, testing, etc.

I'm now at a new company where we build constructions fasteners, threaded rods, nails, anchors, etc. So the product does not involve pretty much operations and most of the operators participation is at changing dies and making setups for the machine that forms and cuts the stainless steel rods.

I'm preparing a PFD but I'm not sure if the setup of the machine must be included as an operation on the PFD? It should be made in very detail? The operator change a lot of parts just to make the setup, but that is not an operation. The operation to me would be how he programs and run the machine.

So how it should be included the setup on a PFD and a PFMEA? I don't want to write a PFD that in the end will look like a work instruction if I include all the steps required for the machine setup (changing gears, screws, dies, etc).


Thanks,
 
Elsmar Forum Sponsor
#3
Set-up from your PFD could hyperlink to photos and other useful detail for RFT set-up.
Ok, but all the steps the operator makes for setup should be included on the PFD? He's not really making an operation but instead he's doing a setup.

To me, the operation on the machine would be "Machine setup", but should I include on PFD also all steps performed on the setup as different operations? It is possible that I just assign "Machine setup" as operation and then include all steps that need to be taken care as "process inputs", i.e. Torque for wire feeder, use line gauge of 0.5 mm, oil level at minimum indicator, etc.

Thanks,
 
#5
To identify process steps, just follow the material and analyse what is being done with it. Machine setup parameters go on the 4M level under machine. Steps that need to be done by the setter are also on the 4M level - under Man. If not done properly, they'd be causes of failure modes of the analysed process step which on its turn would yield product characteristics out of spec.
 
Thread starter Similar threads Forum Replies Date
G Process Flow Diagrams - How detailed the PFD has to be QS-9000 - American Automotive Manufacturers Standard 3
A Corrective Action Column in Control Plan and aligning PFD, PFMEA and Control Plan FMEA and Control Plans 6
Marc Definition PFD - Probability of failure on demand Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
H Functional Safety PFH vs PFD according to IEC 61508 Reliability Analysis - Predictions, Testing and Standards 3
goofygiggler PCP, PFMEA and PFD as one document? APQP and PPAP 5
B Submitting a "Preliminary PFD Definition" Process Maps, Process Mapping and Turtle Diagrams 4
R Redundancy in PFD and Control Plans? APQP and PPAP 3
M Passivation Process Manufacturing and Related Processes 2
G Mfr. Process Validation BEFORE Design Transfer? Other Medical Device and Orthopedic Related Topics 1
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9
D Integrated Management System (IMS) - Process Vs Clause Based Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
D IATF NC Interaction of process diagram - Missing contingency plan Process Maps, Process Mapping and Turtle Diagrams 9
J Cleaning Process for Delicate Parts Manufacturing and Related Processes 4
E Audit Finding - Measurement of Process - Continuous Improvement - Trend Analysis Oil and Gas Industry Standards and Regulations 22
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
I Are suppliers required to hand over process validation reports? ISO 13485:2016 - Medical Device Quality Management Systems 20
S Process Monitoring using SPC software Quality Assurance and Compliance Software Tools and Solutions 6
PQ Systems Introducing Process Improvement to New Employees Using SQCpack Software 0
Quality Runner Continuous monitoring of validated process – sample sizes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H What kind of chart to detect WHEN a in-process NC is about to occur? Reliability Analysis - Predictions, Testing and Standards 2
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3
S Combo Product Assembly Process OQ Qualification and Validation (including 21 CFR Part 11) 0
V Process revalidation periodic criteria Manufacturing and Related Processes 5
G Fully refurbishing process EU Medical Device Regulations 3
A Information on Process-based Internal Auditing Needed Internal Auditing 6
Sortinghat Auditing the Manufacturing Process IATF 16949 - Automotive Quality Systems Standard 3
V Process Owner Quality Management System (QMS) Manuals 1
S Measurment of DPU/DPMO in Assembly process Capability, Accuracy and Stability - Processes, Machines, etc. 1
J Can you have one Core Process (PEAR) with multiple plants? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D "FAI" Requirements/Process for New Supplier Materials Design and Development of Products and Processes 3
W Nonconforming-Material Process Nonconformance and Corrective Action 1
S Performance Qualification and Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
K Sr Process Engineer (Hillsboro, OR) - SPC Program Focused - Ultra Clean Technology Job Openings, Consulting and Employment Opportunities 0
S RFQ Process Automotive Supplier Quality Assurance and other Supplier Issues 1
M Vendor selection process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Process Potential estimation for binary data Capability, Accuracy and Stability - Processes, Machines, etc. 3
M Attempting to Poke Yoke a wire crimping process...need help Design and Development of Products and Processes 3
D Machine rebuilds versus process re-validation IATF 16949 - Automotive Quality Systems Standard 1
G Does TPI agencies comes under outsourced process as per Q1 Oil and Gas Industry Standards and Regulations 11
Q What is Process Auditing? Process Maps, Process Mapping and Turtle Diagrams 9
Z PSW approval process for production IATF 16949 - Automotive Quality Systems Standard 2
G Process Validation Before/After Sterilization? Design and Development of Products and Processes 3
A Layered Process Audits for Medical Device Manufacturing? ISO 13485:2016 - Medical Device Quality Management Systems 3
Derrick Yang 各国医疗器械上市流程的区别 (Differences in the listing process of medical devices in various countries) Service Industry Specific Topics 3
A " I, as a 3rd party auditor, retain the obligation to determine whether or not the process is "effective"... Discuss. Registrars and Notified Bodies 5
J Process capability analysis in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Comparing process parameters on non-normal batches Capability, Accuracy and Stability - Processes, Machines, etc. 11
M How to apply IEC 62304 Problem Resolution Process for bugs discovered prior to release i.e. during initial development? IEC 62304 - Medical Device Software Life Cycle Processes 2
I In-Process Inspection Raw Data ISO 13485:2016 - Medical Device Quality Management Systems 3
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3

Similar threads

Top Bottom