Application of PPAP but no CSRs, blue books in general

Q

qualityboi

#1
I am sure this question has been asked but I just can't find it! Do you have to apply PPAP to your company and your suppliers if you have no customer specific requirements?

Is it a violation of our TS certification if we refuse verbal requests from our customers supplier quality engineers (not buyers) to institute blue book processes such as PPAP after a PO has been approved by both parties and they have already been accepting product for months without it?

There is some thought in our company that you must do PPAP and any of the blue book requirements if your are to be TS 16949 certified regardless if you have CSRs or not, as it is implied, is this true?

(note: we supply to folks like Siemans and Continental who then supply to some OEMs)
 
Last edited by a moderator:
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
I am sure this question has been asked but I just can't find it! Do you have to apply PPAP to your company and your suppliers if you have no customer specific requirements?

Is it a violation of our TS certification if we refuse verbal requests from our customers supplier quality engineers (not buyers) to institute blue book processes such as PPAP after a PO has been approved by both parties and they have already been accepting product for months without it?

There is some thought in our company that you must do PPAP and any of the blue book requirements if your are to be TS 16949 certified regardless if you have CSRs or not, as it is implied, is this true?
The standard says (7.3.6.3),
The organization shall conform to a product and manufacturing process approval procedure recognized by the customer.
This means that if your customer specifies use of the AIAG PPAP process, that's what you have to do. Having said that, however, what you are required to do is a matter of contractual agreement, and if a purchase order (contract) has been issued that does not specify PPAP requirements, you are within your rights to reopen negotiations if new requirements are added, regardless of what those new requirements are. Whether or not there are CSRs is irrelevant (unless PPAP is one of them).
 
Thread starter Similar threads Forum Replies Date
G Where application PPAP my Supplier? Only new products or old products too? Supplier Quality Assurance and other Supplier Issues 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
G Application to Chartered Quality Institute - MCQI ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
U GMDN CODES application ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
R CAMBODIA - Application of AMDD Other Medical Device Regulations World-Wide 3
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P SOUP anomaly evaluation for MMA (Mobile Medical Application) IEC 62304 clause 7.1.3 IEC 62304 - Medical Device Software Life Cycle Processes 6
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Medical Device and FDA Regulations and Standards News 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Informational ISO 18091 - Guidelines for the application of ISO 9001 in local government Other ISO and International Standards and European Regulations 1
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
D I'm new in IMDS special using the IMDS application Manufacturing and Related Processes 8
M Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” Medical Device and FDA Regulations and Standards News 0
S IATF 16949 9.1.1.3 Application of statistical concepts - Our technicians are quizzed for statistical knowledge IATF 16949 - Automotive Quality Systems Standard 3
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
K Need feedback: FMEA Web Application FMEA and Control Plans 5
I FAR Part 43 and Application to 17025 Accredited Cal Lab Federal Aviation Administration (FAA) Standards and Requirements 2
B Request for Information; Application for Accreditation Japan Medical Device Regulations 0
Y Application of IEC/EN 62304 at an advanced stage of software development IEC 62304 - Medical Device Software Life Cycle Processes 4
M What is considered an "Audit Day" for OASIS AEA application? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Ajit Basrur CDRH Premarket Approval Application Critical to Quality Pilot Program US Food and Drug Administration (FDA) 0
Sidney Vianna Blockchain Technology - Any examples of practical application? The Reading Room 21
V Delete Restrictions to be enabled AT BOTH Operating System & Application Levels Qualification and Validation (including 21 CFR Part 11) 1
R Is it legal to attend a trade show while you have a 510(k) application pending? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Zinc Oxide as a Topical Application EU Medical Device Regulations 4
C Application of ISO 9001:2015 Clause Interpretations for Service Industries Service Industry Specific Topics 2
A IRCA Application Form Fill - Guidance ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 22
V Application and differences of OC Curve and Acceptance Sampling Statistical Analysis Tools, Techniques and SPC 2
P Employment Application Form - Controlled or Not? Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom