Design and Development outputs - How Should I audit it? Clause 7.3.3

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T

Ted Schmitt

#2
Re: Clause 7.3.3 Design and Development outputs - How Should I audit it?

Can someone interpret this clause for me? How would I audit it?
The main thing should be if the outputs satisfied the inputs (usually customer requirements or internal corporate requirements)
 

RoxaneB

Super Moderator
Super Moderator
#3
Re: Clause 7.3.3 Design and Development outputs - How Should I audit it?

Can someone interpret this clause for me? How would I audit it?
Welcome to the Cove, hoef17 and congrats on the first post! :bigwave:

Have you taken an auditing course? That should have pointed you in the right direction of what to audit.

If you are looking for specific examples of what to look for, we can not really provide that without knowing what your organization does/produces.

Essentially, though, you should not audit just 7.3.3. Audit the design and development process where you look for things such as:
  • How specifications are determined
  • Minutes of meetings
  • Revisions to drawings
  • Test results
  • ...and so on...
 
H

hoef17

#4
Re: Clause 7.3.3 Design and Development outputs - How Should I audit it?

can you interpret 7.3.3 d for me?
 
T

Ted Schmitt

#5
Re: Clause 7.3.3 Design and Development outputs - How Should I audit it?

can you interpret 7.3.3 d for me?
You should specify in the output phase, any special requirements that your product may need in order to use it safely or adequatly.

Ex : any protection so that no one get hurt using it, warning signs on product, voltage requirements, child proof tops (medicine) etc...
 
H

hoef17

#6
Re: Clause 7.3.3 Design and Development outputs - How Should I audit it?

I am in the manufacturing business. Would operation manuals meet this requirement?
 
T

Ted Schmitt

#7
Re: Clause 7.3.3 Design and Development outputs - How Should I audit it?

Sure, if they installation instructions, maintenance etc.... you should be fine
 

Randy

Super Moderator
#8
Re: Clause 7.3.3 Design and Development outputs - How Should I audit it?

I just created an 8-hour training course on Design and Development (7.3) and here's a piece of it on this subject. My friends here and others helped in the effort.

Outputs must meet the requirements of 7.2.1 a, b, c and d.

Examples of “7.2.1d - “characteristics of the product that are essential for its safe and proper use” are some wonderful things our legal system has brought us such as warning labels that are typically common sense like the shelf on step ladders that have the notice that says “Do not step here”. Other greats are the warning labels on lawn mowers telling you not to put your fingers under the deck while the mower is running; and the safety instruction on steam irons that tell you to “remove clothing before ironing”, whatever that means.


Some examples of design outputs are:
* Schematics
* Drawings
* Proposals, or statements of work (SOW’s) – as in the service
* Organizations
* Formulas
* Prototypes or models (an example of a design output, but not a traditional record)

Outputs should also include information that can allow verification and validation to planned requirements. Additional examples of the output of design and development may also be:

* Data demonstrating the comparison of process inputs to process outputs,
* Product specifications, including acceptance criteria,
* Process specifications,
* Material specifications,
* Testing specifications,
* Training requirements,
* User and consumer information,
* Purchase requirements,
* Reports of qualification tests.
 
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