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Does anyone have any insight as to why Appendix C. 510(k) Process diagram was taken out of the most recent Draft Guidance that was issued on July 28, 2014? In the Draft Guidance that was issued on July 28, 2014, Appendix C. is Sample of 510(k) Summary Complying with 21CFR 807.92.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