how to decide the submission level for PPAP

M

Mobobo

#1
Hello, all.
I am confused now. :confused: I met a project. The production has been approved already, but now need to change the composition for raw material, so the supplier should submit PPAP again, and there are some principles for the submission level for the different situations? :thanx:
 
Elsmar Forum Sponsor
R

Rachel

#2
Mobobo said:
Hello, all.
I am confused now. :confused: I met a project. The production has been approved already, but now need to change the composition for raw material, so the supplier should submit PPAP again, and there are some principles for the submission level for the different situations? :thanx:

Depends on what you're dealing with. Default for bulk materials (i.e., drums of chemical) is a Level 1 PPAP. Default for "pieces" is Level 3. The customer should ultimately dictate which level he/she wants you to submit.

Hope this helps.
-R.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#3
Mobobo said:
Hello, all.
I am confused now. :confused: I met a project. The production has been approved already, but now need to change the composition for raw material, so the supplier should submit PPAP again, and there are some principles for the submission level for the different situations? :thanx:
I would suggest that you contact the customer first to ask if he is willing to approve a change of material. Sometimes the customer will want a financial benefit for approving this change.

In essence the documentation exists and the only new documents are the dimensional report, capabilities and material certs, all the rest you have.
Please ask the customer that is the KEY
 
Thread starter Similar threads Forum Replies Date
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 5
J ISO 9001 - How to decide if a company needs or will benefit from certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L Help me to decide which test to use - If each proportion belongs to the same population Using Minitab Software 7
T Can we remove a quality objective if we decide it is not measurable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B How to decide on a sampling size for Xbar-R charts Statistical Analysis Tools, Techniques and SPC 2
J How to decide work-stream in scope of Quality - Roles and Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
D Service Identification - How can we decide if X is a service or not? Lean in Manufacturing and Service Industries 4
R How to decide a suitable contact time from table 23 of IEC 60601-1:2005 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
C Medical Device Manufacturing in Controlled Environment? How to decide? Other Medical Device Regulations World-Wide 1
M Statistical Method to decide Threshold Value from a Data Set Statistical Analysis Tools, Techniques and SPC 1
P Gauge Design Tolerances - How to decide tolerances for gauge design? General Measurement Device and Calibration Topics 3
C Starting an MSA study - How to decide which is appropriate or required Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Lean or Six Sigma or TOC (Theory of Constraints) - How to decide Lean in Manufacturing and Service Industries 6
H How to decide AQL value? Sampling Plans AQL - Acceptable Quality Level 5
A Who to decide and select Internal Auditors and what are the criteria? Internal Auditing 18
M CAPA Rankings to decide if action is required Nonconformance and Corrective Action 7
D Who should decide on my salary and adjustments? Career and Occupation Discussions 9
P How do you decide what is an acceptable Internal and External PPM number? IATF 16949 - Automotive Quality Systems Standard 17
M Overhaul QMS or start over? How do you decide? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
P How do you decide what is a Process, a Procedure or Work Instruction? Document Control Systems, Procedures, Forms and Templates 89
J To Decide Which Factor has the Highest Influence on the Results Using Minitab Software 3
K Regulatory Requirements for ISO 13485 - Which country to decide? ISO 13485:2016 - Medical Device Quality Management Systems 6
B How to decide the ?U? to calcuate DPU and "opportunity" of DPMO Six Sigma 8
L Is the EPA is going to decide if the SPCC deadline is to be extended? Miscellaneous Environmental Standards and EMS Related Discussions 1
M CA (corrective action) or Continuous Improvement? It's hard to decide. Nonconformance and Corrective Action 19
Y How do we use SPC or other stat tools to decide product spec? Statistical Analysis Tools, Techniques and SPC 5
D On-going capability - Can we decide for ourselves how often to measure cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 6
J Part submission warrant for Level 1 PPAP APQP and PPAP 1
N Traditional 510K Submission-Financial Certification or Disclosure Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B Health Canada Submission Canada Medical Device Regulations 2
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
S Pre-Submission for Breakthrough Device Designation - What's the threshold? US Food and Drug Administration (FDA) 8
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
G Gage R&R - Where am I going wrong? Part of a FAIR submission (Aerospace) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
A Some doubts about traditional 510(k) submission US Food and Drug Administration (FDA) 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
S PMS (Premarket Submission) and PMCF Plan EU Medical Device Regulations 5
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
J IMDS submission details for aluminium wrought alloys APQP and PPAP 5
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
S Two or more predicates suitable? 510K submission US Food and Drug Administration (FDA) 5
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
M Timing of 510k submission Other US Medical Device Regulations 9

Similar threads

Top Bottom