SBS - The best value in QMS software

Process changes

M

Martin

#1
I had a question: I have difficulty with the fact what exactly a process change (4.9.5.) is. I will give an example. If our operators change the setting of the machinery I think it's a process change, but if we have to register every time that happens the paperwork isn't "funny" anymore. Can somebody give me a good explanation of process change?

Thanks in advance,
Martin
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Is this in regard to resubmission of PPAP to address an 'official' process change?
 
M

Martin

#3
It isn´t regard to resubmission, because I get that, but it´s regard to point 4.9.5. Which states the following:
The supplier shall maintain records of process change effective dates. (see 4.5.3.)
Note: Changes to promote continuous improvement are encouraged. Consult the customer for guidance on approval requirements for such changes.

And I don´t know how I must see the process changes in this case. The same as with the PPAP submission. Maybe you could tell me...

Thanx anyway,
Martin
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
If you change a stated process parameter it is a process change. If you change a set-up procedure, a control plan (one or more items) or other process particular, you are changing the process. Typically this is a non-issue as the documents are controlled and as such a history of changes is found in the documents themselves. Most companies look to their Engineering Change System as the repository of a history of process changes and their implementation dates/times. An important factor is looking at this with regard to traceability as well.

What requires resubmission of PPAP is variable and has been discussed in a number of threads here. Do a Search here (maybe for 'resubmit' or PPAP). If you don't find anything, come back to this thread and let me know. I'll help out from there. OK?
 
M

Martin

#5
OK.. I get it, so I don´t have to document every change that my operators make when the change the parameters am I right? Because the way I see it now is that you have a total process change (changing set up instructions, process flow, etc.) or part process change (changing parameters)....

Thanx, Martin
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
You have a lathe operation. You notice that you are getting a 'trail' on your piece. Your inspection shows that although this 'trail' is visible, the part passes your surface roughness requirement. You slow down feed rate 10% from set-up and the problem worsens. The operator increases the feed rate 20% from set-up and the problem goes away. The responsible engineer changes the CNC set-up program to reflect this 20% increase. Is this a process change? I wouldn't classify it as such but you can get an arguement that it is. It really has no effect on the product - it was passing (technically) prior to the change and the change of a feed rate is not (opinion on word choice) significant.

You have to make some decisions on a case by case basis what is 'significant' to your process.

Where operators can make adjustments they are typically 'minor' - you want an engineer involved if a 'major' problem arises. Where the operators are 'tuning', they are not really changing the process. In the lathe example operators are allowed to adjust feed rate +/- 30% from set-up. They do not have to get authorization to do this. However - it is expected that the responsible engineer (or other 'authority') be (in general) monitoring what is going on so that s/he knows if every operator on every shift is always setting the feed rate up 20%. The operators are not, however, required to record the change unless it is in response to an out-of-control condition where it is recorded on the control chart.

However, if you change the set-up instruction it technically becomes a process change, but is it significant? Not in my opinion. I don't believe 4.9.5 is meant to control this type of minor process change. I see 4.9.5 as important in more 'significant' process changes such as a change from a grind to a hone, a large process parameter change (such as mold temperature or hold time in injection molding) or a sequence change.

[This message has been edited by Marc Smith (edited 23 May 2000).]
 
Thread starter Similar threads Forum Replies Date
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
S Qualification Builds & Process Changes (AS9102 - First Article Inspection) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O PFMEA - Reducing Severity (S) Ranking - Manufacturing Process Design Changes FMEA and Control Plans 4
A Process Changes, but Work Instructions/Process Maps are not updated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Form for Managing Coating Process Parameter Changes during Production Document Control Systems, Procedures, Forms and Templates 2
J Process Changes - Customer Notification Requirements APQP and PPAP 12
R Verification of Process Changes (AS9100 clause 7.5.1.2) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
AnaMariaVR2 FDA, Suppliers, & Process Changes [article] Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M AS 9100 4.2.4 Process for making changes to records is not fully effective Quality Manager and Management Related Issues 4
V ECR/DCR Process Flow - What changes require an ECR vs. a DCR Document Control Systems, Procedures, Forms and Templates 2
L Changes to Manufacturing Process or Device with CE Marking CE Marking (Conformité Européene) / CB Scheme 2
M Changes Assessment as per AS9100 Clause 7.5.1.2 Control of Production Process Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T How to link Process Design Changes in Serial Production to Design & Development? Design and Development of Products and Processes 6
M Document Changes not affecting the process - Adding Logos, etc. Document Control Systems, Procedures, Forms and Templates 8
5 Changes to Control Plans or PFMEA's (Process FMEA) FMEA and Control Plans 6
M Process changes related to Components APQP and PPAP 4
R Informing Customers of Process Changes - Is this considered a process change? Manufacturing and Related Processes 19
R Preventative Action - Organizational ideas - Process or Work Instruction Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S PPAP for my tier 3 suppliers - Sub-Supplier Process Changes APQP and PPAP 16
M Looking for Best Way to Communicate Process Changes to Production Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Defining Process Changes and Customer Notification Requirements IATF 16949 - Automotive Quality Systems Standard 33
R Manufacturing Process Changes (7.1.4) IATF 16949 - Automotive Quality Systems Standard 3
J Process Control / Changes QS-9000 - American Automotive Manufacturers Standard 13
K APQP - Is the APQP process supposed to include process changes? APQP and PPAP 2
B Toyota PPAP Process - Three Questions APQP and PPAP 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
V Laser Welding Process - Impact on Electrical Properties Reliability Analysis - Predictions, Testing and Standards 4
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
N Riveting - special process Manufacturing and Related Processes 11
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 15
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
D Measurables for Plastic Injection molding process Manufacturing and Related Processes 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
R Inspection and Work order process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6

Similar threads

Top Bottom