Design Validation Work Instruction - Help

S

sohar45

#1
Dear all,

This is a great website which showers many information in various area. A must see site.

I work for a medical device company and look into the Design Verification and Validation organization of my company. I have a question with regard to Design Validation Work Instruction.

Just to give a quick background, we have a very strong Validation Plan at the moment, but I think there are certain areas in the Plan which could be potentially converted into a work instruction document. Any text that we would expect not to change much from one plan to the next can be left in the document. I am actually stuck here....and looking forward for your help!

Please can anyone suggest me the first step. Incase anyone has a WI for Design Validation, please help me in sending the same. I really appreciate your help.

Best wishes,
Sohar

 
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Stijloor

Staff member
Super Moderator
#2
Dear all,

This is a great website which showers many information in various area. A must see site.

I work for a medical device company and look into the Design Verification and Validation organization of my company. I have a question with regard to Design Validation Work Instruction.

Just to give a quick background, we have a very strong Validation Plan at the moment, but I think there are certain areas in the Plan which could be potentially converted into a work instruction document. Any text that we would expect not to change much from one plan to the next can be left in the document. I am actually stuck here....and looking forward for your help!

Please can anyone suggest me the first step. Incase anyone has a WI for Design Validation, please help me in sending the same. I really appreciate your help.

Best wishes,
Sohar

Don't get too hung up on document formats. How you structure and name documents is entirely up to you. If you would like to break up a very long complex document into smaller documents and decide to call them work instructions, that's OK. What is often ignored is to confer with the internal users and ask them what would work best for them. The content, format and identification has to work for the internal customer only! Not to please an outside entity such as a registrar, auditor, or whatever.

Stijloor.
 

yodon

Staff member
Super Moderator
#3
Stijloor is, as usual, quite correct. Just one thought to add.

What you describe is, to me, more of a template. A WI would tell someone how to do something whereas the template provides the structure and possible content for getting there. What I typically see and have done is to save off the template (controlled document) and then write a WI providing guidance on how to use the template to develop a new plan; e.g., what text can be changed, what project-specific details need to be added, etc. You could combine the instructions in the templat but I have found that folks tend to forget to delete the instructions. Like Stijloor said, though, make it work for you / your company.
 
S

sohar45

#4
Hi there,

Thanks for your replies. I really appreciate that. I think the same way. However these are some of the sections which I normally use in my Validation Plan :

- Introduction
- Reference documents
- Features to be Tested
- Features not to be Tested
- Approach
- Artifacts
- Test management

I think these are most important things which should stay back in the Plan than in a WI. Do you think any of these items can be treated in a WI?

Regards,
Sohar
 
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