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
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
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
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
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 9100, Nadcap and related Aerospace 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 9100, Nadcap and related Aerospace 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 9100, Nadcap and related Aerospace 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
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 2
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 7
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C OEE and In-process Inspection Manufacturing and Related Processes 2
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
V Informational SMMT IATF Oversight - OEM KPI Process IATF 16949 - Automotive Quality Systems Standard 4
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10
Similar threads


















































Top Bottom