Level 3 PPAPs

I'm looking to see what others have done when a Level 3 PPAP has been requested. We are thinking about having just a cover page for the Control Plans, PFMEAS, and Flow charts instead of submitted the actually documents. Have any other companies taken this approach. I know in the PPAP 4th addition it says those documents need to be submitted with the PPAP but we are saying those documents are proprietary.
Elsmar Forum Sponsor

Howard Atkins

Forum Administrator
Staff member
This is very common in Europe not to supply them.
You can always say that the customer can see them on site (Level5).
This can be a legal issue as you should have told them at contract review

Matt's Quality Handle

Involved In Discussions
It's a discussion that needs to happen with your customer/supplier rep. It's not an unreasonable ask for you to claim proprietary information, which I've seen most commonly in the PFMEA. It's usually accompanied by a statement that PFMEAs are available for on site review as requested.

But be prepared for your customer to actually come on site to review them. I've also been allowed to review via webex.

Dan M

Involved In Discussions
Sorry that I'm late to the PPAP party. I am in the US and work for a global company headquartered in Europe. Our standard PPAP is level 3. We use an excel template that has 19 sheets representing each document that is required by a level 3 PPAP. For the process flow diagram, control plan and P-FMEA we include these documents, but only show a header and footer. The body of each has a disclaimer "Proprietary Information - May be reviewed on site at the plant." We do not allow them to be shown via Teams or Webex because anyone could take a screen shot.


Forum Moderator
Staff member
FWIW, there is very little about most processes that is truly unique to the point that it is really proprietary. I have been in many plants with so-called proprietary processes that were nothing special, and were often technologically behind the times.

My recommendation would be to share the information (> 95%) that is not proprietary and redact the information (< 5%) that is truly proprietary.
Thread starter Similar threads Forum Replies Date
M Packaging level EU Medical Device Regulations 2
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 16
A % of defects on the whole batch based on result from inspection under AQL Level II Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
R IATF and ASPICE level 2 Design and Development of Products and Processes 9
B ANOVA 3 level and 4 factors f and p values are not showing Using Minitab Software 0
J Part submission warrant for Level 1 PPAP APQP and PPAP 1
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
was named killer Onsite Level II N.D.T. Training in Florida Training - Internal, External, Online and Distance Learning 0
D High level understanding of EUDAMED EU Medical Device Regulations 3
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 10
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Level 3 KPI Excel Template Manufacturing and Related Processes 1
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
R Bottom up approach versus system level ISO 14971 - Medical Device Risk Management 2
C Failure nets - Same level effects FMEA and Control Plans 0
H Graphical analysis of results - Confidence level bands nomenclature Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Level of Clinical Evidence - MDR EU Medical Device Regulations 3
D GM BIQS level 5 requirements Customer and Company Specific Requirements 5
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Level 3 PPAP submission of intentional defective parts APQP and PPAP 4
eule del ayre List of Level 3 PPAP requirements for automotive suppliers APQP and PPAP 20
I Document levels and approval requirements for lower level documents like work instructions, forms etc. Document Control Systems, Procedures, Forms and Templates 18
B AS9102 FAI & Lower Level Drawings - How should we perform the FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Rameshwar25 What is a Control Plan at "Material Level"? IATF 16949 - Automotive Quality Systems Standard 4
N How to resolve discrepancies in Level 3 PPAP supplier dimensional reports? APQP and PPAP 11
M Creating a Plant Level Value Stream Map Process Maps, Process Mapping and Turtle Diagrams 1
K Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
P GM BIQS level 5 training? Training - Internal, External, Online and Distance Learning 2
Ron Rompen Dual level holes - Measurement method suggestions wanted General Measurement Device and Calibration Topics 9
A Level of details required for Class IIb Product Verification and Validation CE Marking (Conformité Européene) / CB Scheme 1
D System Level FMEA example wanted FMEA and Control Plans 2
samer Do we have to determine Educational level for all Staff as pr 7.2 b clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J What level PPAP for 5 critical parts? APQP and PPAP 8
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E High level structure - Planning and operation control Occupational Health & Safety Management Standards 2
rob73 Worldwide device regulatory authorities at country level Other Medical Device Regulations World-Wide 6
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
C Example Work Instruction/Procedure for AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 4
W Level of V&V in Class II Medical Device (Dialysis Machine) IEC 62304 - Medical Device Software Life Cycle Processes 10
K FDA Premarket Submissions for Embedded Software - Level of Concern Other US Medical Device Regulations 4
Highground Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
A What KPI's do you use at Shop Floor Level and Team Boards? Quality Tools, Improvement and Analysis 4
T Struggling with ISO 13485:2016 Clause 6.2 - Level of Risk Associated with Work ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom