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
B How to satisfy clause 5.7.1.5 process validation for valve production API 6D Oil and Gas Industry Standards and Regulations 13
C Change Management Process ISO 14971 - Medical Device Risk Management 8
B Documents for production process IATF 16949 - Automotive Quality Systems Standard 8
J Process Capability - Determining the process capability of certain equipment Lean in Manufacturing and Service Industries 6
Z E-Coating process International Specifications? FMEA and Control Plans 3
W CQI-15 for new welding process IATF 16949 - Automotive Quality Systems Standard 3
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
M Process & Product Characteristic in Control Plan FMEA and Control Plans 17
S Consolidated Analysis Report for Moulding Process Manufacturing and Related Processes 1
P ISO 11607-2 Process Specification Other Medical Device Related Standards 1
Q Best off presentation of process flows Process Maps, Process Mapping and Turtle Diagrams 16
Q Logistics process flow ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Process FMEA for Laser Cutting/Press Brake/Welding FMEA and Control Plans 2
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
F Is this misuse of the MRB process? Manufacturing and Related Processes 7
L Product and process Deviation procedure Manufacturing and Related Processes 1
Ch00Ch00 How to evaluate a process ? Document Control Systems, Procedures, Forms and Templates 3
M Implants made by Additive Manufacturing process approved by USFDA Other Medical Device and Orthopedic Related Topics 1
Q Process Key figures and reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Ch00Ch00 Evaluate a process - Issue number Lean in Manufacturing and Service Industries 7
F Rules of process outsourcing in China China Medical Device Regulations 1
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
P Certification process for registered device China Medical Device Regulations 12
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Melissa Process Validation of Rotary Heat Sealer Speeds Design and Development of Products and Processes 4
C Validation of process for releasing the UDI EU Medical Device Regulations 4
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 13
C Validation of process for production and servicing 5.7.1.5 API Spec Q1, 9th Edition Oil and Gas Industry Standards and Regulations 9
Z IA Construction Procurement Process Internal Auditing 3
H Risk Management Plan in agile process ISO 14971 - Medical Device Risk Management 14
DuncanGibbons Process flow & PFMEA for production planning and simulation activities? Process Maps, Process Mapping and Turtle Diagrams 7
N Help with understanding Process Controls Manufacturing and Related Processes 7
M VDA 6.3 – Workshop for Certified Process Auditor VDA Standards - Germany's Automotive Standards 4
C Process Consistency Manufacturing and Related Processes 5
K Business Process Flowchart Process Maps, Process Mapping and Turtle Diagrams 2
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
J License renewal process in Iran Other Medical Device Regulations World-Wide 0
J Definition Outsourced process - Clear definition - 13485 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
S IS0 13485 process flows ISO 13485:2016 - Medical Device Quality Management Systems 2
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
C Revalidation of Process Equipment for Equipment Transfered to New Facility. ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Process map Evaluation and Analysis Method Process Maps, Process Mapping and Turtle Diagrams 5
S In process inspection Manufacturing and Related Processes 2

Similar threads

Top Bottom