process flowcharts (process diagrams)

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    Assembly House Process Chart

    Hello all, In working on getting quality management up and running at an assembly house we worked on creating a detailed process flowchart to get a better picture of the interaction of processes and what needed to be documented and formalized in procedures. Just wanted to get your guys feedback...
  2. R

    PPM, Pictorial Process Mapping, Templates

    We are looking into internal development of manufacturing process control procedures. Priority to distilling the multi-page "Word" documents into a concise "picture flow". There are several current software applications available but are very restrictive in format/style. Has anyone...
  3. E

    Process diagram and intranet communication software

    Hello all, We are currently going through a QMS "Revival" stage and are looking for a software which would help us communicate procedures which we have in place (Issue being, nobody follows procedures (or even knows them...) at this time) This is only one part of the whole initiative, but i...
  4. J

    Please help me understand what a process is

    Hello all. First, this is such a wonderful site and you all are so knowledgeable. Thank you so much. I work in a small company - 12 people. Small distribution center. I think I have an understanding of ISO as it applies to us, but I am still unsure about a process versus a procedure...
  5. A

    IATF 16949 Cl. e) - Manufacturing Process Flow Charts & Layout

    Dear all, As per IATF 16949 , one of the manufacturing process design output is - manufacturing process flow charts / layout , including linkage to product , process and tooling Does this mean that process flow diagrams should have reference to product, process and tooling? Kindly share...
  6. G

    Process for Product Safety - Ideas for Documenting Process for

    I am looking for ideas for documenting Process for I am new to this, help please!
  7. K

    Which Symbols are used in Process flow diagrams?

    Dear friends, I want to know the symbols which are used in Process flow diagram.. Please revert asp. Regards Moorthi
  8. O

    Process Mapping prior to Validation and Software to use to Map

    Hi all, We need to map our processes and then evaluate for validation/measurement points and perform validation as needed (we are ISO 13485 medical device manufacturers). I am wondering what software people use to map processes and any pros & cons?
  9. M

    Does a process map satisfy 21 CFR 820.20(d) (Quality Plan)?

    I've looked through the thread What is a Quality Plan? What Should be in a Quality Plan?, but it is dealing with ISO requirements. As far as the FDA regulation goes, 21 CFR 820.20(d) states only: "Each manufacturer shall establish a quality plan which defines the quality practices...
  10. R

    510(k) Draft Guidance issued: 2011 vs 2014 - Appendix C. 510(k) Process diagram gone

    Does anyone have any insight as to why Appendix C. 510(k) Process diagram was taken out of the most recent Draft Guidance that was issued on July 28, 2014? In the Draft Guidance that was issued on July 28, 2014, Appendix C. is Sample of 510(k) Summary Complying with 21CFR 807.92.
  11. A

    Can the BOM in SAP be used in lieu of process flow diagram?

    Process flow diagram is one of the requirements of PPAP. In SAP (ERP), BOM defines the process sequence to be followed. Can the BOM in SAP be used in lieu of process flow diagram? This will avoid duplication. What are your views?
  12. S

    How can I make a Process Flow Diagram for APQP process

    Hi, I am working as a Supplier Technical Assistant. My Team is very big team and i need give the direction to the people through procedure.. I need help that How i can make process flow for APQP process. please suggest me. Regards, Selva::rolleyes:
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    Software for linking Process Flow Diagram, Process FMEA and Control Plan

    i have been assigned the project of moving our companies current system (using MS Excel/Access) for process flow/pfmea/CP to APIS IQ. Any help you can offer in terms of getting started with the software, training resources or any would be good. In a nutshell: i aim to offer a live archive all...
  14. Ron Rompen

    Document Flow Chart Assistance

    We were recently audited by Ford in preparation for a new job. The first audit was the technical audit, to make sure that we had all the equipment available to do the job per Ford's requirements. The next stage is the SQA visit, when they will audit a current manufacturing process, to evaluate...
  15. N

    How Can I Simplify This Process Flow?

    Hello Covers, I wanted to ask for your thoughts on how to simplify our Order Tracker Process... What it comes down to is that the Order Tracker is passed through so MANY hands before the job ships out. Sometimes it is even passed back to the same person a number of times. We have used this...
  16. S

    US FDA PMA (Pre-Market Approval) Process Flow Chart Example

    Hello Can anyone share or update the step by step process flow chart of US FDA PMA approval process?..
  17. S

    Flow or Procedure to generate a "Pflichtenheft"

    Hi, does anyone here have a Process Flow or Procedure documenting / describing the way how to create from the Lastenheft ( product specific requirements ) a Pflichtenheft ( statement of work ) ? If so, a copy would be very much appreciated ! Thanks, Steven
  18. M

    Process Flow Diagram -> PFMEA -> Control Plan Linkage

    Good day everyone, I am updating our Process Flow, PFMEA and Control Plans. I have a few questions regarding their content. The documents that are currently in our system are, IMO, too generic yet they contain unnecessary steps. Process Flow: We have been using the Process Flow format...
  19. A

    Feedback on Approach to Flowcharts ISO 9001

    I have been a visitor to this site for about 5 years and it has provided me with wonderful guidance and advice just by reading threads and utilsing examples. We have developed numerous quality management systems and safety and environmental management systems for clients for many years and we...
  20. N

    What is the relationship between a DFMEA and PFMEA?

    Hi, Friend, I'm suffering a headache question, Waht's relateionship between DFMEA and PFMEA. In my understnading, PFMEA is linking to DFMEA, DFMEA is design concept and setting RPN number, detection action, prevention method to reduce the risk before product transfer to production...
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