4.9.3 Modified Process Control Requirements

O

ovidiomolina

#1
I'm confused about this clause. I can't understand if it is refering to cpk's or it is taking about some product characteristic in particular.

Can anybody out there explain to me ?

Thanks
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
I think this means - say you have a supplier who cannot keep a high Cpk because of a tight tolerance (or whatever excuse / reality). Then they have to have a tight inspection in the Control Plan compared to what they would have if they could hold a high Cpk.
 
B

Batman

#4
I think Marc is correct. I also think that this section is a "out" for customers to specify something that may not be stated elsewhere, such as a generic performance specification or tolerance on a drawing.

We have had a couple of occasions where there was a new requirement for testing that was a result of a failure long after a product had been in production. Example, a customer is suddenly experiencing breakage, so we instituted a break test sample. This was added to our control plan. It is not necessarily stated anywhere on the customer's drawing or specifications, however.

If there is some requirement, such as a higher Cpk, you should have addressed this in APQP, including a feasibility review, anyway. So requirements above the minimums in QS9000 and APQP and Control Plan manuals should already have been addressed.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
There is the problem of reality vs APQP. Supplier goes thru APQP and just about PPAP when the capability run is done, it's discovered that the measurement method of a characteristic isn't valid or the tolerance is taken up in measurement uncertainty. All the early theory simply didn't prove out or someone forgot something (yes, we are human and human systems do fail rom time to time). So - do we get the engineers to do an 11th hour engineering change to open up the tolerance? Or do we allow the supplier to carry a low Cpk with 'special' receiving inspection? Do we make a hard gage for the check or do we write a CMM program? Will an optical comparator be a better choice?

The bottom line is you continue to try to solve the problems and get on with the show. Reality is a pain in the ass. Systems developed to comply with the APQP 'philosophy' are, in my opinion, a positive control factor - This is to say I have a firm belief in defined design systems and in the APQP philosophy, if you will, as a basic control of 'holistic' and coordinated product evolution.
 
Thread starter Similar threads Forum Replies Date
D Modified Control Limits - Process that has points out of control Statistical Analysis Tools, Techniques and SPC 9
T Product Labeling - Modified the name of one of our products EU Medical Device Regulations 5
E AS9102 FAI - What makes a COTS modified? (PCB assemblies) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
P Special 510(k) - Modified Medical Device Description Other US Medical Device Regulations 8
qualprod Risk impact can be modified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R ISO 13485 Certificate Scope modified by Notified Body EU Medical Device Regulations 9
Marc Modified Google Glass can teach you Morse Code in four hours World News 0
V Modified chi square statistic test (mCSRS) Statistical Analysis Tools, Techniques and SPC 1
V Risk Assessment Precedence - FMEA > Risk Matrix (Modified PHA) > Ishikawa? FMEA and Control Plans 11
H ECG Modified Lead Placement - IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
E Extent of modification to be considered as Modified Adoption Other ISO and International Standards and European Regulations 1
D Divisions delay QMS Certification due to un-modified Organization Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Medical Device Re-Labeling question - Customer has modified the labels ISO 13485:2016 - Medical Device Quality Management Systems 17
D CE Marking Modified Machinery CE Marking (Conformité Européene) / CB Scheme 3
C 1040 vs. 1040 Modified Bar Stock - Material Question Manufacturing and Related Processes 7
J What is "Modified Control Chart" Statistical Analysis Tools, Techniques and SPC 11
Jim Wynne Genetically-modified yeast leads to more efficient ethanol production World News 0
B Will ISO 9001 be modified in 2008? What will happen to TS 16949? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
I Gage R&R confidence limits - Bootstrap methods or MLS (modified large-sample) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
C Calibrate before equipment gets modified? General Measurement Device and Calibration Topics 5
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 3
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Error Proofing Label process Manufacturing and Related Processes 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
K Problems with process equipment ISO 13485:2016 - Medical Device Quality Management Systems 4
W Need for current design or process control FMEA and Control Plans 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 6
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
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) 8

Similar threads

Top Bottom