Design and Development in a small company

T

ttwerp65 - 2009

#1
Our company is a built to print shop. We do have a couple of products that we design, develope, build and sell. Thes are only about 2% of our product. These parts are tools. A tube bender and an accu-tapper. Basically, how little can we get away with? Does anyone else deal with this? How are you doing it?:confused:


7.1 (d) Evidence that the realization processes and resulting product fulfil requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Design and Devolopment in a small company

The percentage isn't an issue. If you do design you're responsible for having an appropriate system and compliance to related ISO 9001 requirements.
 
R

Rooch

#3
Re: Design and Devolopment in a small company

We to are a build to print type of shop, and have design responsibility.
When we issue a print to build to our shop, we attach what we call a RTM- or request to manufacture cover sheet. It holds a vast amount of info- like the customer, ship to instructions, quantity to build, design input parameters delivery dates required, but it also shows the print number, and activities associated with the print, like review dates, revision numbers etc. the print itself has title blocks with revision levels, and a description of the changes. It also holds areas for verification to the design inputs meeting the design outputs (what is on the print).
Design Validation must take place after the (whatever) is built- then tested to ensure it meets the specifications.
Supplier evaluation- this should not be hard- just keep notes or records somewhere on the supplier you evaluate.

Dont be afraid to be creative, but think to yourself, where am I going to point the auditor when he asks to see the record. It is my opinion that if you can point him somewhere- then the worst that will happen is the process will need to be modified (depending on his findings, if you meet the standard or not). Hey - remember there is always continual improvement!

I dont know if this helps- I hope so. Anyway have a nice day
Rooch-:bigwave: :bigwave:
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#4
Re: Design and Devolopment in a small company

Marc is right.

If you design/develop the requirements of Paragraph 7.3 and sub paragraphs thereof would apply. The documentation will need to be available, when asked by an External/3rd Party Auditor. If your QMS is written to include the documentation stated, and as long as the evidence is available you shouldn't have any problems (this opinion is based upon not knowing how your QMS defines the design aspect of ISO9001:2000, paragraph 7.3 and subs).
 
F

fuzzy

#5
Re: Design and Devolopment in a small company

Our company is a built to print shop. We do have a couple of products that we design, develope, build and sell... Basically, how little can we get away with? Does anyone else deal with this? How are you doing it?:confused: ...
Per the other gents, you must comply with the intent of the standard, but in a way that makes sense for your business. We for example spell out the multiple formats that each of your listed requirements may be met, and we also set a minimum level of evidence for each stage. For instance, design review could be that an engineer specifies a print # for a particular work traveler (the record), and initials their review. For a complex large-scale project we will generally require a sit-down, cross-functional, design review meeting with minutes as the record. You need to assess the criticallity (sp) of each step in these design processes, and determine for your business what is appropriate to manage the risk of not doing those steps well enough.:):2cents:
 
M

Martijn

#6
Re: Design and Devolopment in a small company

IMHO it can be a checklist as simple as this:

1 Design and development inputs relating to product requirements
2 Results of design and development reviews and any necessary actions
3 Results of design and development verification and any necessary actions
4 Results of design and development validation and any necessary actions

and then for each step
a. reference to evidence/documents/record
b. actions required & taken
c. approval by authorized employee

arrange for changes to be entered onto the checklist or a new checklist is made
 
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