Subcontracted Services - Permissible Exclusions

J

juliedrys

#1
If a company subcontracts an activity such as Design Control, is this a permissible exclusion?

My opinion is that it is not an exclusion, as it would be if the company were not responsible for design (if we build-to-print, for example -- customer provides the design). The standard clearly states that it cannot be excluded if it affects the organization's ability or responsibility to provide conforming product.

In my opinion, even if you don't have the capability to do design but the customer holds you responsible for it, it cannot be excluded. Furthermore, if the activity is subcontracted, the subbed processes must be identified and controlled (per clause 4.1).

This seems fairly obvious to me, but an instructor in an RAB-approved Transition Course I took stated that this subcontracted design activity would be a permissible exclusion. I wholeheartedly disagree, in this case, but am curious how others would address this in their quality manual? Would you include section 7.3, but state that the activity is subcontracted (and therefore controlled)?

It's very interesting to observe these initial (and varied) interpretations of the new standard.

Any feedback would be appreciated. Thanks. This site is very useful...

ps) Anyone else have the new standard on their Palm Pilot? It's cool.

------------------
Julie Drysdale
BSA
408-395-1928
 
Elsmar Forum Sponsor
D

Dan Larsen

#2
I tend to agree with you, Julie. I think the key is the fact that your company is taking the responsibility for the design.

Now, with respect to the manual, I think I would write it in that (and this assumes that all design work is subcontracted) the company subcontracts but takes responsibility for design, and that the subcontract designers are subject to purchasing requirements that reflect and incorporate the requirements of the design clause. Then I would prepare a purchasing document that would become part of the PO package that goes out to the supplier. I'd also audit my supplier to make sure he is conforming to the requirements.

Can't say I've ever run across this (I tend to work with non-design companies), but it would seem the logical approach.

Playing the devils advocate, I guess it might be possible to argue that the design clause doesn't apply to me if I subcontract all the design work. But if I were the auditor in that situation, I think I would take a hard look at how the company is controlling the subcontracted work. I'd also carefully consider the scope of the registration. If the word "design" is in the scope of the registration, I think it would have to be a finding if there were no design controls.
 
D

Doug Stimson

#3
Check out www.tc176.org titled "subcontracted or outsourced processes.
".......outsourced or subcontracted to an external organization is NOT adequate justification................
 
G

gutieg

#4
To me, subcontracting the full design work can create other problems, since there is always a need to align the customer requirements not only to engineering specs but also to the manufacturing or service processes. When you subcontract part of the design work (do testing, make drawings, etc.) it can ve valid for optimal resource utilization, but IMHO the design process is one that you should own and manage so direct interaction with customer and interal areas are assured. Summarizing, I think that some specific design activities could be sub-contracted and managed as a purchase but if you want to do that with the full design process it can be difficult to handle from the point of view of a certificaton audit.
Only if your company does not carry out design at all may be justifiable to exclude this requirement for iso 9001.

Gus Gutierrez
 
#6
I tend to agree with your instructor. I suggest you speak with the registrar you will be using. Find out if, according to the circumstances with your company, the registrar will allow the design function to be listed in your company scope.

I have implemented ISO in a number of companies where the design function was out-sourced. It was not included in the scope of registration for the reason that the companies had only limited control over the out-sourcing, not to the extent as when the design is a part of your own facility.

Other considerations, is the design an element outlined on your organization chart; this would be difficult to audit internally and would need to be a supplier audit.

awk
 
J

juliedrys

#7
First of all, thanks to everyone for the replies. To clarify, this is not an actual case at my company; I am a consultant (uh oh). This was a question posed as an example in a 9000:2000 Transition training course.

The guideline found at www.tc176.org is very clear about this: "Where the overall responsibility for product realization belongs to an organization, the fact
that a specific product realization process (such as product design and development or
manufacturing) is outsourced or subcontracted to an external organization is not an adequate justification for the exclusion of this process from the QMS."

However, I also agree that it would not be very common to outsource all of your design work and still take responsibility for it.
This was simply an excercise in the class; in a real-life circumstance, I suppose other factors could apply.

I much more commonly see manufacturing being outsourced, however, and this is why I asked.
In this case, the company cannot say that the manufacturing requirements do not apply; in fact, they are responsible (through their supplier management system) for managing their suppliers to ensure sufficient control.
In this case, the scope of the registration reads "...for the design and management of manufacturing of..." It's a bit awkward, but this is what the registrar recommended.



------------------
Julie Drysdale
BSA
408-395-1928
 
D

David Mullins

#8
Covered under purchasing, I believe. External auditors should assess your ability to ensure that the purchased designs meet your requirements.

I recall a question that was very similar to this one, about a year ago, and there was a fair bit of debate in the thread.

At the end of the day, it depends on the degree of control your company wishes to economically and efficiently apply to this process.

My standard caveat of making sure you're adding value by your interpretation applies.

------------------
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
->Furthermore, if the activity is subcontracted, the subbed
->processes must be identified and controlled (per clause
->4.1).

When you outsource design, you look at your outputs to the design company and their feedback (their output) to you. You have to define the requirements for them to do the design (purchasing of a service). If I build a building and I subcontract the design part (maybe I'm just a turn-key who coordinates getting everything together and getting the building built), my procedures and such have to describe what outputs I have to each service I sub-contract as well as purchasing related aspects). In so far as design goes, if I do anything 'listed' in section 7, it is applicable to my registration. If I don't, it's not. I would state my output to the design firm but it may be I'm responsible for part or all of of 7.3.1. I have to ask myself what I do and do not do as I go thru the standard line by line.

->In my opinion, even if you don't have the capability to do
->design but the customer holds you responsible for it, it
->cannot be excluded.

You're outsourcing it and the customer simply holds you responsible for it. This doesn't change anything at all - you're outsourcing it whether the customer requires it or not because it is not a 'core function' to your business.

Look at your part in the whole thing. Say I farm out the design but I do validation testing in-house. I'm 'responsible' for addressing the requirements of 7.3.6. I cannot say I am not responsible for addressing 7.3.6 just because it is a sub-clause of 7.3.
 
G

gooofii

#10
hello every body
am rewriting a QM for my company for the BSI...i get stucked in the Quality Assurence for the Control of Sub Contract companies. To be honest the company was ignoring to put standard criterion process for accepting or rejecting a subcontractor. so if any one can give me ideas about wht should be the rules and regulations for accepting a subcontract company for {water tank builders}..:notme:


Thank you for your time
Gazzar
 
Thread starter Similar threads Forum Replies Date
F ER Checklist for a Class III Medical Device - Subcontracted Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
C Writing a Sterilization Procedure when the Process is Subcontracted - ISO13485 Quality Management System (QMS) Manuals 1
G Manufacturing Process Subcontracted - How do I handle Cl. 7.5? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
Anerol C How should I control subcontracted infrastructure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C The relationship between OEM and the subcontracted manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Inspecting subcontracted manufacturing of garments, wearing apparel Manufacturing and Related Processes 5
CalRich Subcontracted laboratory per 5.10.6 - Whose name goes on the Calibration Certificate General Measurement Device and Calibration Topics 1
R Sample Retention - Subcontracted Plating Service - PPAP Requirements Service Industry Specific Topics 11
A Inspection Plans - Subcontracted Electronics Assembly Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
L Special Processes for SERVICES AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
I Custom software services to be used by medical software ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational EU – New notified body designated under the MDR – NB 1912 – DARE!! Services B.V. – Netherlands Medical Device and FDA Regulations and Standards News 0
M Authorized Representative services for the EU Recommendations EU Medical Device Regulations 3
S Responsibility of intercessor services provider about services's quality ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Education authority requires approval of all courses - Training services provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Clause 8.2.2 Determining the requirements for products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO 9001 Clause 8.3 Design for an education services provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Maintain and repair services company require ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
J ISO 17020 concerns of independence & impartiality of services Other ISO and International Standards and European Regulations 1
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Jen Kirley Conway Business Services LLC - Jen Kirley ISO 14001:2015 Specific Discussions 0
A Medical device CER (clinical evaluation report) training/seminar services EU Medical Device Regulations 2
M Informational EU – Eudamed Data exchange services and entity models introductions Medical Device and FDA Regulations and Standards News 4
M Informational EU – M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations Medical Device and FDA Regulations and Standards News 0
M NIST is one of the government services shut down General Measurement Device and Calibration Topics 2
M Medical Device News New ANVISA health services public consultations – Consultas públicas de serviços em saúde Medical Device and FDA Regulations and Standards News 0
A ISO / IATF 16949 Requirements for Second Party Services IATF 16949 - Automotive Quality Systems Standard 10
I Imaging Services - Which standard should we be certified to? ISO 13485:2016 - Medical Device Quality Management Systems 4
R Creating WIs for a Heavy Civil Engineering Services company Document Control Systems, Procedures, Forms and Templates 19
T Value Chain Map for Food Services Industry Service Industry Specific Topics 1
qualprod Auditing Product and Services doubts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Identifying externally provided services referenced by IATF16949 IATF 16949 - Automotive Quality Systems Standard 2
qualprod Including services in quality policy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
P Design and Development Clause ISO 9001:2015 Exclusion for Medical Services Design and Development of Products and Processes 3
Q Partial non applicability of ISO 9001 Cl. 7.1.5 (not having services)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Are contingency plans required to list the sources of alternate products or services? IATF 16949 - Automotive Quality Systems Standard 2
A What does 8.2.2.1, Determining the requirements related to products and services,mean IATF 16949 - Automotive Quality Systems Standard 1
B Is a parent company who provide services to its subsidiary a Supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
julsbear Corporate Services as Externally Provided Service IATF 16949 - Automotive Quality Systems Standard 1
Y ISO 9001 Cl. 8.3 - Design and Development of Products and Services not applicable ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Company) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Controls for Suppliers of Translation Services - Receiving and Verification Supplier Quality Assurance and other Supplier Issues 5
Sidney Vianna ISO 20700:2017 - Guidelines for management consultancy services Other ISO and International Standards and European Regulations 2
N ISO 17025 Clause 4.6 Purchasing Services & Supplies (Compliance) ISO 17025 related Discussions 3

Similar threads

Top Bottom