NPI (New Product Introduction) Quality Plan Outsourced Manufacturer/Supplier

K

Kloser43

#1
#1
Hi,

I have just joined a life jacket manufacturing company which predominantly uses outsourced suppliers to manufacture our products. I am new in such a working environment and have been charged with creating a NPI quality plan for newly designed jackets. I would like support on the detail required for the Q plan.

Obviously - scope, project name, targets etc etc.

1:I need ensure all specs are complete/signed off before reaching supplier
2: Levels of testing required to ensure conformity
3: Inspection checklists provided to suppliers to ensure conformity
4:process for reporting Non-conformances
5: Appendix showing individual jacket test criteria, health and safety, marine safety SOLAS etc

Ideas would be great! :) Thanks
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
K

Kloser43

#4
#4
Thanks Pancho,

Yes we do have a QMS, though the company has not long been under the umbrella of a larger organization. They have had to convert from internal manufacturing to around 80% third party manufacturing company, so it is still a work in progress. I need to try and make the NPI procedure more full-proof.

Thanks again!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S New Product Introduction Procedure - NPI Document Control Systems, Procedures, Forms and Templates 1
T Raw Parts Inspections for NPI (New Product Introduction) Phase Supplier Quality Assurance and other Supplier Issues 1
S Monozukuri Rules for NPI (New product Introduction) - Help to get Lean in Manufacturing and Service Industries 3
Q Procedure for New Product Introduction (NPI) - Build to print shop Various Other Specifications, Standards, and related Requirements 6
S NPI (New Product Introduction) in Electronics Industries Document Control Systems, Procedures, Forms and Templates 10
Y NPI (New Product Introduction) Process Qualification System Required Document Control Systems, Procedures, Forms and Templates 8
C Definition NPI (New Product Introduction) Readiness - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
Q Internal Program audit Scope for NPI 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Excel Templates for Plan & Define Phase in NPI Process for Tire Manufacturer Excel .xls Spreadsheet Templates and Tools 1
N Have any different between NPI and APQP ? APQP and PPAP 1
K Definition NPI, PPCR, QFD, NCR, DOE - Abbreviations Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
L 1 product multiple factories EU Medical Device Regulations 0
C Product Lifetime on Labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
P API Q1 - Monogram Product & API 4F - Proof Load Test Oil and Gas Industry Standards and Regulations 3
R CE marked product sold in UK no EU rep CE Marking (Conformité Européene) / CB Scheme 2
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
Awais How to mistake proof - Shipping Orders with Shortages - Product Quantity Accountability mismatch with Job Traveller? Manufacturing and Related Processes 17
L Product and process Deviation procedure Manufacturing and Related Processes 1
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
B Design Responsibilities for Mature Acquired Product Lines ISO 13485:2016 - Medical Device Quality Management Systems 3
D Dental application - medical product or not? Other US Medical Device Regulations 8
Q Product Quality vs Product Defects Manufacturing and Related Processes 4
J Verification of purchased product / supplier questionnaires ISO 13485:2016 - Medical Device Quality Management Systems 2
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Product Code 510(k) exemption US Food and Drug Administration (FDA) 1
M REACH assessment of PCBA/finished product REACH and RoHS Conversations 2
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
Q News cradle to grave - Product life cycle ISO 14001:2015 Specific Discussions 5
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
W Final Report re: Market withdrawal of radiation-emitting product Other US Medical Device Regulations 0
M Combination Product - New MAA EU Medical Device Regulations 0
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
Z REACH compliance for low volume product REACH and RoHS Conversations 1
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
A UDI for product already packed up EU Medical Device Regulations 0
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 5
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
K Interesting Discussion "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 4
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4

Similar threads

Top Bottom