Performance Test Results - for TESTS or for REQUIREMENTS specifiied in Design Record?

C

Corey Jordison

#1
Situation:
- design record of purchased part contains 18 functional requirements (temperature resistance, etc.)
- design record says that 12 of them shall be tested annually
- supplier is providing me a PPAP with Performance test results for 12 requirements
I am rejecting the PPAP and saying to supplier: hey, there are 6 requirements missing.
Supplier's response: hey, we don't have to test the other 6, because the design record is saying that we have to test only 12 requirements out of 18

I am preparing my response: hey Supplier, you are wrong, see PPAP manual clause number... and then I open the PPAP manual in order to check for clause number and see in clause 2.2.10 that supplier shall have performance tests results for tests specified in design record. For tests, not for requirements specified in design record. Does it mean that my supplier is right and they only have to submit 12 test results?

On the other hand: they have test methods described in design record for 15 requirements out of 18, which makes it even more crazy...

So how many test results they must submit to me:
- 18, because this is the full list of requirements from design record
- 15, because test method is described only for 15 of them
- 12, because design record is saying that they shall test only 12 of them

Thank you very much in advance for your replies because I'm lost here...
 
Elsmar Forum Sponsor
G

guruprasadb

#2
Re: Performance Test Results - for TESTS or for REQUIREMENTS specifiied in Design Rec

hi,

1. In principle, supplier need to submit for all 18 requirements.
2. As per design record supplier to test for 12 requirements annually once.
3. Remaining 6 requirements supplier has to have a frequency to perfrom testing / or you need to provide him the frequency based on the criticality

If go through PPAP 4th edition Foreword & Purpose we can find

"....all customer engineering design record and specification requirements are properly understood by the supplier and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate"
 
C

Corey Jordison

#3
Re: Performance Test Results - for TESTS or for REQUIREMENTS specifiied in Design Rec

Thanks a lot for your help! That's perfectly answers my question!
 

Jim Wynne

Staff member
Admin
#4
Re: Performance Test Results - for TESTS or for REQUIREMENTS specifiied in Design Rec

Situation:
- design record of purchased part contains 18 functional requirements (temperature resistance, etc.)
- design record says that 12 of them shall be tested annually
- supplier is providing me a PPAP with Performance test results for 12 requirements
I am rejecting the PPAP and saying to supplier: hey, there are 6 requirements missing.
Supplier's response: hey, we don't have to test the other 6, because the design record is saying that we have to test only 12 requirements out of 18

I am preparing my response: hey Supplier, you are wrong, see PPAP manual clause number... and then I open the PPAP manual in order to check for clause number and see in clause 2.2.10 that supplier shall have performance tests results for tests specified in design record. For tests, not for requirements specified in design record. Does it mean that my supplier is right and they only have to submit 12 test results?

On the other hand: they have test methods described in design record for 15 requirements out of 18, which makes it even more crazy...

So how many test results they must submit to me:
- 18, because this is the full list of requirements from design record
- 15, because test method is described only for 15 of them
- 12, because design record is saying that they shall test only 12 of them

Thank you very much in advance for your replies because I'm lost here...
hi,

1. In principle, supplier need to submit for all 18 requirements.
2. As per design record supplier to test for 12 requirements annually once.
3. Remaining 6 requirements supplier has to have a frequency to perfrom testing / or you need to provide him the frequency based on the criticality

If go through PPAP 4th edition Foreword & Purpose we can find

"....all customer engineering design record and specification requirements are properly understood by the supplier and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate"
2.2.10.2, on page 7 of the 4th edition PPAP manual:
The organization shall perform tests for all part(s) or product material(s) when performance or functional requirements are specified in the design record or Control Plan.
It seems to me that if there are 18 functional requirements expressed in the design record, the supplier must provide data in the PPAP submission for all 18, but only 12 of them must be retested annually.
 
Thread starter Similar threads Forum Replies Date
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
E Particular standards, essential performance in EMC Immunity Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Standard for Reliability/Performance Test on a Electro Mechanical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Test Lab for JIS T 1501 (Performance of Ultrasonic Pulse-Echo Diagnostic Equipment) Japan Medical Device Regulations 1
T New Packaging Line Performance Qualification (PQ) - Minimum Test Times ? Qualification and Validation (including 21 CFR Part 11) 3
K Performance Evaluation Study for our list A products like HIV ELISA test EU Medical Device Regulations 1
O Numbers of units tested for Material/Performance Test - PPAP manual chapter 2.2.10.1 APQP and PPAP 1
A Uncertainty in Test - Durability test, High Performance, Salt Spray chambers, etc Measurement Uncertainty (MU) 5
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G What does performance specification include? US Food and Drug Administration (FDA) 1
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
M IVDR and Performance Evaluation Plan CE Marking (Conformité Européene) / CB Scheme 2
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Performance of high shear mixer (or rapid mixing granulator Qualification and Validation (including 21 CFR Part 11) 4
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
B Four Key Performance Indicators for Continual Improvement (Dec. 3 2019) [Deleted] Training - Internal, External, Online and Distance Learning 2
F 5520A High Performance Multi-Product Calibrators General Measurement Device and Calibration Topics 0
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
O Performance Measurement ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
H How to prepare Performance Qualification (PQ) for autoclave General Measurement Device and Calibration Topics 2
M Performance Standard for Balloon Trocars Other Medical Device Related Standards 2
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
qualprod Ineffective follow up of people performance - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P Is there a counterpart to the General Safety and Performance Regulations for the USA? Other US Medical Device Regulations 2
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 2
M Informational EU draft act – Single-use medical devices – safety and performance requirements for reprocessing Medical Device and FDA Regulations and Standards News 0
B Essential Performance of a Cone Beam Computed Tomography Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
M Characterization Testing - NO acceptance criteria, no minimum performance requirement Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D IEC 60601-1 - Essential performance doesn't make sense IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
M Product Performance Claims Other Medical Device Related Standards 4
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
M Informational USFDA Final Guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 2

Similar threads

Top Bottom