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

K

Kloser43

#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
 
Elsmar Forum Sponsor
K

Kloser43

#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!
 
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
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
A Software bug fixes after shipping a product EU Medical Device Regulations 3
S How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
S California Cleaning Product Right to Know Act - Product Label advice needed Miscellaneous Environmental Standards and EMS Related Discussions 1
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
H PCD remains valid for new product ISO 13485:2016 - Medical Device Quality Management Systems 11
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
E How do you determine if hipot is necessary for a cable product? Manufacturing and Related Processes 8
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
N Authorised Representative details on product label? EU Medical Device Regulations 1
D Importing a general wellness low risk product Other US Medical Device Regulations 3
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 0
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 4
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
H Remote product audits in Coivd-19 - IATF 16949 9.2.2.4 IATF 16949 - Automotive Quality Systems Standard 3
B EU MDR Perscription product guidance EU Medical Device Regulations 1
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
B Product Safety Responsibility - Job shop such as a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Miner Quality checks of product QR codes FMEA and Control Plans 2
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
G Handling Unpacked (Additive Chemical) Product For Automotive Applications IATF 16949 - Automotive Quality Systems Standard 3

Similar threads

Top Bottom