Process Mapping prior to Validation and Software to use to Map

O

orangeisenergy

#1
Hi all,

We need to map our processes and then evaluate for validation/measurement points and perform validation as needed (we are ISO 13485 medical device manufacturers). I am wondering what software people use to map processes and any pros & cons?
 
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yodon

Staff member
Super Moderator
#2
Re: Process mapping prior to validation, and software to use to map

Before going too far down a rabbit-hole, take a step back and recognize that the only thing you NEED to do is to validate those processes whose outputs are not / cannot be verified (and software used in the implementation of the processes or the quality system).

Certainly, mapping is a handy tool.

I've always found it's best to figure out how you do things and then find tools that align. You might try something as simple as Visio (or similar basic drawing / mapping tools) just to get the processes down on 'paper' for discussion. And instead of going first for tools, consider the methods that work best for you (flowcharts, swimlanes, etc.)
 

Stijloor

Staff member
Super Moderator
#3
Hi all,

We need to map our processes and then evaluate for validation/measurement points and perform validation as needed (we are ISO 13485 medical device manufacturers). I am wondering what software people use to map processes and any pros & cons?
My most favorite type of flow chart is the Deployment Flow Chart.

The biggest advantage is that it helps the user understand the responsible party for all the listed process steps.

I believe that VISIO has the capability to develop Deployment Flow Charts; at least the version that I used to have.

Here are some examples.
 
O

orangeisenergy

#5
Re: Process mapping prior to validation, and software to use to map

Before going too far down a rabbit-hole, take a step back and recognize that the only thing you NEED to do is to validate those processes whose outputs are not / cannot be verified (and software used in the implementation of the processes or the quality system).

Certainly, mapping is a handy tool.

I've always found it's best to figure out how you do things and then find tools that align. You might try something as simple as Visio (or similar basic drawing / mapping tools) just to get the processes down on 'paper' for discussion. And instead of going first for tools, consider the methods that work best for you (flowcharts, swimlanes, etc.)
Yes, I realize you only need to validate what is not measured, and we feel (along with the suggestion from our auditor) that we start by mapping our manufacturing processes and look for any control points. We can then determine if they are measured, or if will validate them. First step, we are writing a Master Validation Plan, also getting our processes down on paper (so to speak); then we can identify our control points, and determine the need to validate. We are starting with our manufacturing/production processes, for this.

We will have to buy Visio, so I just wanted to check on the Cove if anyone suggested any other mapping software or tools as we progress in detail with these process maps.

I was unfamiliar with the term "Development flowchart", but that is exactly what I was picturing, and plan on doing. Thanks for the terminology and examples! :thanks:
 

Peter Fraser

Trusted Information Resource
#7
My most favorite type of flow chart is the Deployment Flow Chart.

The biggest advantage is that it helps the user understand the responsible party for all the listed process steps.

I believe that VISIO has the capability to develop Deployment Flow Charts; at least the version that I used to have.

Here are some examples.
Add to that, the RACI methodology adds the "how are people involved" element to each step in the process.

PS not sure that Visio is the best option for deployment flowcharts if you want to publish an integrated system with links to supporting documents and references to standards, risks, control points etc?
 

Stijloor

Staff member
Super Moderator
#8
[snip] PS not sure that Visio is the best option for deployment flowcharts if you want to publish an integrated system with links to supporting documents and references to standards, risks, control points etc?
I am not familiar with VISIO's current capabilities. I am sure that there is software with more advanced capabilities as you described.
 
Q

QABJH

#9
Re: Process mapping prior to validation, and software to use to map

Yodon,

I work for a small company that doesn't have a product on the market yet. I would like to keep things as simple as possible. The products that this company is developing are small in software (maybe one circuit board) and uses some chemicals in an IVD application. The product(s) will be designed in a joint effort of my company and a consulting company.

My company purchased templates from another consultant. The Software Development SOP is complex. Just wondering whether anyone has an example of a simple Software Development SOP.

We were also given a Human Factors SOP which is complex as well. Would anyone have an example of a simple Human Factors SOP?

Thanks
 

ncwalker

Trusted Information Resource
#10
If you want to know what software to do you mapping in, the answer is Excel.

While Visio is geared towards doing this, my experience with specialty packages is this:

You need a bunch of site licenses, so that limits the people who can open your file.

It's another thing to learn (these days, most everyone at least knows their way around Excel).

You can't beat it, honestly. If you're just plopping shapes down and not using the full battery of advantages you get from Visio, you're better off in Excel. I don't even use Minitab any more because of the site license thing. There's nothing Minitab can do that Excel can't.
 
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