Subcontracting Finished Product

Russ

Quite Involved in Discussions
#1
I have been asked to look into issues with ISO covering some jobs that we are going to subcontract out as finished when we receive them, then we just box them up and send them to our customer. I need help clarifying just what I may need to change to make sure we still comply to ISO 9002:1994. I have visited some older threads on this and I am still confused about the whole thing. We have a lot of stuff partly made outside but this is a different animal to me. Do I just need documentation to support our QMS (traceability,inspections etc) from the subcontractor?:confused:
 
Elsmar Forum Sponsor
H

HFowler

#2
Russ,

Although you are needing to comply with ISO 9002:1994 at this time, it might be worth looking ahead at the requirements from ISO 9001:2000. Regarding outsourced processes, clause 4.1 says:
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

Regarding ISO 9002:1994 I would start with looking at 4.2.3 Quality Planning. The first sentence states:

The supplier shall define and document how the requirements for quality will be met.

I think this is the place to describe the controls your organization has over outsourced processes to ensure that requirements for quality are met. Then I would look at 4.6.1 & 4.6.2. They really mirror in more detail what ISO 9001:2000 says in clause 4.1.

I'll leave the part about traceability to someone else to address. In my past experience, traceability was not a requirement for our product, but I did require traceability by lot to inspection records. I did this mainly to comply with the requirements for Inspection and Testing in section 4.10.

I would encourage you to look at certifying your subcontractor to provide documented evidence of inspection and conformity so that you don't have the burden of re-inspecting unnecessarily. Once you're confident that you have a certified supplier, your job of ensuring that the requirements for quality are met can be reduced to supplier audits, and if necessary inspection of random samples.

I hope this helps.

Best Regards,

Hank
 
S

Spaceman Spiff

#3
My company purchases private label products from the Far East and markets them in our catalog along with ones manufactured in the USA. How we address this issue is by performing incoming inspection on products as if they are components. This way as Hank suggested, it is covered by 4.6 (ISO 9001: 1994). We also require these suppliers to be ISO certified or working towards certification.
 
D

DonkeyKong

#4
7.5.1 and 7.5.2?

Does subcontracting in a way have anything to do with 7.5.1 and 7.5.2? Validation of special processes.....The company I'm working for doesnot provide any service provision but production provision....I've always found this section difficult to expand and write....can I exclude part of these two sections?....Or does this have more to do with qualifying suppliers and their processes?...Hope this is in the right section....as always I appreciate any help...this site has all sorts of good info!!!:)

Thanks
DK
 
H

HFowler

#5
DK,

I don't read 7.5.1 or 7.5.2 as applying to subcontracted product or to the qualification of suppliers and their processes. I believe that 7.5.1 refers to the controls that a company has over its production or service processes. It involves making sure that the appropriate information and equipment are available and implemented. In a manufacturing environment, this would mean having the current revision of drawings, proper work instructions, and the necessary inspection equipment being used correctly,

I believe that 7.5.2 refers to a product or service that can't be deemed acceptable until it is in its application. In other words, you have to wait until a service is performed or a product is installed before you can evaluate whether it meets the intended requirements.

This is just my opinion. Read on for the viewpoint of others.

Hank
:)
 
Thread starter Similar threads Forum Replies Date
M Subcontracting a repair of Medical Devices Canada Medical Device Regulations 0
D Subcontracting specification developer duties US Food and Drug Administration (FDA) 5
D Subcontracting Clinical Evaluations EU Medical Device Regulations 1
T Is Testing in a Third Party Facility Subcontracting? General Measurement Device and Calibration Topics 2
G Subcontracting work (manufacturing) to another company location EASA and JAA Aviation Standards and Requirements 4
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Subcontracting of Tests and Calibration - ISO 17025 Clause 4.5 ISO 17025 related Discussions 1
C Establishment Register Question - Subcontracting - Blood Glucose Monitor System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Subcontracting and Control Issues - Class I Medical Devices with Measuring Function ISO 13485:2016 - Medical Device Quality Management Systems 5
Qwatcher2 FAI Help - Subcontracting out all manufactured items (PCB & machined parts) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Definition Subcontracting vs. Outsourcing - Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
A Subcontracting Inspections and Tests - ISO 17020:1998 clause 14.2 General Measurement Device and Calibration Topics 9
J Class IIa Medical Device and Subcontracting questions ISO 13485:2016 - Medical Device Quality Management Systems 3
A Definition Outsourcing vs. Subcontracting - The Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 11
K Subcontracting of Tests and Calibrations - ISO 17025 Sec: 4.5 ISO 17025 related Discussions 11
J ISO 9001 procedures content - Subcontracting electrical and instrumentation Document Control Systems, Procedures, Forms and Templates 6
T Supplier subcontracting requirements and Distributor requirements Supplier Quality Assurance and other Supplier Issues 5
S Definition Outsource - Outsourcing - Subcontracting - Definition - TS 16949 and ISO 9001 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
V External Processes - Subcontracting - Control Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L PMA and Non-PMA parts in same finished goods area? Federal Aviation Administration (FAA) Standards and Requirements 1
M Contract Manufacturer of a Finished Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
E Brazil - RDC 183 - Finished device - Definition Question Other Medical Device Regulations World-Wide 1
V GRR Study on a Finished Product - Batch Manufacturing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
R 510(k) - Finished Test Reports - RTA - Bit of a Complaint 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
V AQL for Component Level and Assembled Finished Product AQL - Acceptable Quality Level 1
alonFAI Finished PCB Final Visual Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
C Off-The-Shelf requirements (Finished Medical Devices) Other Medical Device and Orthopedic Related Topics 2
J Tracking and Traceability of Finished Goods ISO 13485:2016 - Medical Device Quality Management Systems 6
S Does Contract Manufacturer need to issue Food Grade certificate for finished device? US Food and Drug Administration (FDA) 1
J Discrepancy in Manual Counting - Finished Goods Boxes ISO 13485:2016 - Medical Device Quality Management Systems 13
JanWarner Importing a Finished Medical Device from China (tooth whitener w/ peroxide) China Medical Device Regulations 2
M Definition Receiving Inspection of Parts, finished products, service parts etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
S Three Questions on Finished Medical Device Traceability, Labeling and Packaging US Food and Drug Administration (FDA) 3
shimonv Storage of finished medical devices per 21 CFR Part 820.150 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
T SOP for How to Write a Specification for Raw Materials and Finished Good ISO 13485:2016 - Medical Device Quality Management Systems 3
A Outsourced Processes Control (Finished Medical Device Delivery, Storage) ISO 13485:2016 - Medical Device Quality Management Systems 10
V What is the difference in cGMPs for API vs Finished Dosage forms ? US Food and Drug Administration (FDA) 2
M Supplier PPAP for Interim Materials - Oil to test functionality of finished product IATF 16949 - Automotive Quality Systems Standard 4
P Surface Finish measurement for machined (finished) component/part Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C When to submit a 510(k)? After the DMR (Device Master Record) is finished? Other US Medical Device Regulations 4
R Outsourcing of a Semi-Finished Product - Which major things to address in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
6 Catering HACCP/Food Safety - Traceability from Receipt to Finished Product Food Safety - ISO 22000, HACCP (21 CFR 120) 1
V Device Retains - How many people keep retains of finished devices and why? US Food and Drug Administration (FDA) 6
L Assessing Corrosion Damages on Steel finished externally with Epoxical Paint Various Other Specifications, Standards, and related Requirements 1
M Definition Brief Period of Time relative to Temperature Excursions for Finished Products Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
B NAFTA Requirements - Finished Product or Materials/Parts from Suppliers, too? RoHS, REACH, ELV, IMDS and Restricted Substances 2
W Stent Coverings and Stents - Finished Medical Device or not? US Food and Drug Administration (FDA) 3
K Raw Materials from 3rd World Countries vs. Finished Products from 1st World Countries Philosophy, Gurus, Innovation and Evolution 23
C D&D (Design and Development) Requirement for Semi-Finished Products Design and Development of Products and Processes 4
V Creating a Cosmetic Inspection Specification for Powder Coated Painted Finished Parts Manufacturing and Related Processes 7

Similar threads

Top Bottom