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How to transition smoothly from an existing QMS
When some people are at the final step of their decision to go for MatrixQMS application, we often receive the following questions:
"How much time does it take to implement a QMS in MatrixQMS?"
"Is there an easy way to make the transition from our existing QMS?"
Unfortunately, the best answer to these questions is often "It depends...".
Actually, it depends on multiple factors that are relative to your company:
Do you have a QMS implemented and in which format?
How many procedures, forms and templates do you need to transfer?
Do you want to use the full power of Matrix from day 1 or not?
How much resources do you have for this task? Is there a dedicated person?
In this article, we focus on the scenarios where you already have a QMS in place and want to move it to MatrixQMS. It will be up to you to decide how much an in which speed to switch from a paper based system to MatrixQMS. Even by only transferring some parts into Matrix you will already benefit. A full implementation of MatrixQMS depends mainly on your available resources and needs dedicated to this.
But the bottom line is that, from day 1, you can be operational using Matrix in all the different scenarios!
Scenario 1 – Using the existing template structure available in MatrixQMS
MatrixQMS comes with a structured template composed by different Procedures making the gap analysis with the ISO13485:2016. This is helpful for companies that are creating a QMS from scratch and can start adapting each Procedure within the proposed structure.
This scenario can also be for a company with an existing or partial QMS. The content of each procedure from our template can be adapted with your own process inputs. A partial QMS could be that your company got some procedures from a consultant who started to adopt them to your own needs. In that case, you could end up with lengthy procedures with a lot of compromises to do and transferring this content into the existing structure in MatrixQMS would definitively help to clarify its content.
During that step of transfer, you can take the opportunity to extract the good stuff from your revised documents and put them in smaller efficient processes which really fit your needs.
We propose this split for many reasons:
Each process as a clear input and output.
It is short and has one specific topic.
Through traceability you can make sure it fulfills all the regulatory requirements.
You easily and quickly review, update and improve it, without touching all the processes in the same domain.
As an example, see the Design Control Procedure we propose in MatrixQMS:
Depending on how many existing procedures you have this task can be time consuming but you will end up with something cleaner, easier to maintain and most important fitting your companies needs as well as the regulatory requirements.
Scenario 2 – Transferring your actual Documents in the current template structure
Another decision could be to look at the proposed structure and transfer your actual procedure at the right place. In that case, you can decide for example to use one rich text box field in the PROC item and copy inside your actual content of your procedure.
This will allow you to easily control the procedures within MatrixQMS and adapt its content later on. An easy way to transfer the content is to use the “convert to text” functionality:
At this stage, your actual QMS content is stored in Matrix, controlled, and can be easily edited if needed by adjusting the text, adding more information in other fields, mentioning the responsibilities, the trainings etc.. This could be done step by step at the time you need to adapt some procedures for example.
Scenario 3 – Using the application to control your actual Documents
The fastest way to convert an existing documentation to MatrixQMS, you can decide to simply attach your existing document to a PROC item. You can do that using the actual structure of MatrixQMS (similar to scenario 2) or starting from scratch. In this case, you can create one new PROC item per existing document into MatrixQMS.
If you “drop” any document (word,pdf,excel,…) in a rich text box field, you can simply decide to “attach” the file and it’ll be available as an hyperlink and as a file attachment within your PROC item:
When all your documents are attached to one Matrix item each, you can decide to approve and publish like this all your elements within MatrixQMS. You’ll have your digital Quality Manual composed by all your current documentation available as attached files. So, you're actual documentation can be controlled using Matrix Requirements!
Besides attaching the final pdfs or word documents you can also for each process add a short summary which is published along with the downloadable procedures as part of your digital Quality Manual. This will help users to quickly "preview" a procedure before actually reading it, e.g. a CAPA procedure could have a link to the CAPA database and some important information on how to fill it out in the preview. All the processing and follow-up which is done and described in the process can stay in the attached document.
From that point, each time you have a process to adapt or a change to implement, you can decide to transfer the content of your document into dedicated Matrix fields to build the actual PROC item. You’ll then be able to use all the functionalities of MatrixQMS for that particular procedure and can do that work more in an ad-hoc way when a procedure needs to be updated. Your QMS will take more time to be fully integrated in MatrixQMS but the transfer will be done bit by bit.
The important thing to consider how to go digital is to plan ahead how much time you have: you can make it a project, e.g. reserving two weeks time to do the full transfer, or spend only a little time in the beginning, cleaning things up as your QMS evolves and needs adaptations. Both methods allow you to maintain an existing QMS while improving it for the future.
This can be summarized like this:
|1||Restart with predefined procs||- leads to best fine grained QMS which is easy to update and maintain - full change control - best traceability to standards - easy to find and read specific processes (instead of reading big PDFs) - very easy to update, review and publish individual processes (rather than big procedures)||- can be a lot of work if you have already many procedures in place||No established QMS in place|
|2||Import and convert DOCS||-once imported the procs can be split into smaller processes whenever they need changes -you can benefit from version control, review and approval and publication and training features -you can benefit from online QMS web page (published quality manual)||-loss of formatting, loss of 'word' features -trainings for big procedures is more difficult to develop and execute||With limited time or with established / solid paper based QMS|
|3||Link PDFs||- existing documents don't need to be changed - you can benefit from review and approval as well as training features - the PDFs can be made available in a controlled manner through the QMS web page||- changes of PDFs need to be control and managed outside of Matrix - users need to download published PDFs from website (instead of reading it online) - no full text search in PDFs||Want to start as quickly as possible|
Note: you can also start with method 3 or 2 and once you need change your processes / procedures split them up (so you have a mixed system in place).
Any auditor knows that a change like this would require some adaptation and time but as it’s for the better, he will always encourage you to take that direction.
So, success, you're on the good path!