I am a relatively new user of version 5 Q-Pulse, and I was asked today whether the application could be used as a tool for managing process change control. (not document control)
I've considered designing a change control document template and using the document module to control these completed documents as I would any other document within our QMS.
Then I thought that there may be a solution to be found in the CAPA module, maybe even through a change control wizard and designing a change control template with predefined stages.
Has anybody used Q-Pulse to for process/system change control and would be willing to share their experiences.
Many thanks,
Martyn
Hi Martyn,
Yes we've done exactly that! I set up a wizard and template in the CAPA module and it seems to work quite well. We unfortunately have a checklist that has been imposed on us by our corporate owners that has to filled out in a certain format, but all I've done is added a stage that states "Complete Checklist."
So far, it's worked quite well, although we've only used it for the big changes. We have an initial risk assessment stage, then approval (with actions created as default to the relevant approvers), filling out the checklist stage, further approval (again with actions defaulted to relevant approvers once the testing/validation etc has taken place) and implementation.
However, I am in the middle of designing a whole new system in the IMS modules. I'm designing a form to replace the checklist in the Occurence modules and the same template (minus the "Fill Out Checklist" stage) in the Incidents module. The beauty of it is that risk assessment is built into this module as well and CAPAs can be raised from it.
However, the main problem (which I think will always be regardless of how the change system works) is getting people to use it rather than just make a change as they feel like it. Thankfully, because QPulse has made it so easy, this is less of a problem then it was before.
Feel free to get in touch if you want to ask me about any of it. Hope that helps!
Another way of doing it might be to create a "virtual" document named for the process of interest and just use the change request & approval features of the Documents module.
I've done something similar by creating a virtual document for our Laboratory Information Management System. Whenever a change is proposed it has to be submitted as a change request which can be linked to a change request document that references any validation or other files and the CR is formally approved in QPulse and then the document number is incremented (e.g. the supplier's version number has a suffix corresponding to the number of in-house changes - ver 7.03.001, 7.03.002 etc). This provides an audit trail that satisfies change control requirements and a log of when changes were implemented.
Come to think of it, you could make the virtual document link to a MS Visio or other process map and even use the multiple document links to link to other relevant documents.
Gary Cheung
Quality & Risk Manager
Department of Haematological Medicine
King's College Hospital
garycheung@kch.nhs.uk
Hi Garry Could you please tell me more about these 'virtual' documents', I am in the same predicament and want to attach HTMP copies of our process diagrams into the system. Are they used as 'coat hangers'?
Good morning Martin,
We are a Defence Co. and have been audited by the MoD on our Engineering Change System which I put on to QP as a Wizard and a Template, this was a reflection of the flow chart and the paper documents. It has worked very well and has been agreed by the MoD as a very robust system. What I like about it is the simplicity on the QP system and the checks I have built into it.
I hope you have similar success.
Cheers
Leigh
Hi Harry
I use document records that are in document type categories like Management, Qulaity or Software Instruction and use the title & Change Details fields to desribe the process or system to which the record refers.
In the case of an IT system, there won't be a file to attach to the record, whereas there would be for a process map.
Every time a change is proposed the proposer completes a change request form (ours is an MS Excel form customised from the one Microsoft have on their MS Office help web pages) and adds a change request in the documents module to the relevant virtual document record (the change request form can be attached to the change request as well). The Document Owner then considers the CR and, depending on the size & nature of the change proposed, there will be additional, formal change impact assessment and approval +/- validation of the proposed change in a test environment (for software changes). I suppose you could test/validate a process change in the same way, although I haven't done that yet.
Once the change is approved, the virtual document has the new draft approved with a summary of changes made in the Change Details field. The Document Number is then incremented (e.g. suppliers version & build number plus a suffix to represent the local version 7.03.159.001 to 7.03.159.002)
This enables a change history, including approval to be maintained.
One difficulty I have with this is that it can be difficult to persuade users to make only one change at a time, whereas they are keen to see all proposed changes implemented as quickly as possible. Of course, none of this prevents a user with high enough security rights making unapproved changes to a software system, but it does enable you to beat them with a stick when they have not followed the procedure.
Leigh,
I would be very interested to hear more about how you have developed an ECN control system through QP5. We have tried a number of ways (through doc control and CAPA) and none have been able to provide enough detail and information.
Regards
Ken
Hi Ken,
Have you seen the new IMS modules in Qpulse? These are ideal for capturing data and carrying out investigations as you can create any form to capture whatever data you need and attach it to investigations. You can make the forms as simple or as complicated as you want. You create all the fields (deciding the field type as well - free text, drop downs, tick box etc) and call them what you like. You can also make them mandatory. I'm in the middle of moving our change control process over to these new modules now and it looks like it will work quite well. We previously used CAPAs to do this and had quite a complex template assigned to it to capture what we needed.
Sounds interesting Lauren,
Dare I ask what version of QP5 the IMS module comes with? Is it beyond V5.21?
The IMS part of Q-Pulse was released with Version 5.5 of Q-Pulse, so cannot be used with Q-Pulse 5.21 or below.
The minimum requirements for Q-Pulse 5.6 with the Integrated Management System can be found here. The IMS option requires .NET Framework 3.5, Windows Server 2003 and SQL Server 2005 to run.
Please note that the IMS option is a purchasable extra.
Daniel Rae Web Community Champion Gael Ltd t: +44 (0)1355 593 435 f: +44 (0)1355 579 191 w: www.gaelcommunity.com
As Daniel said Ken, it's an extra to buy. But the amount of things you can do with it makes it well worth it. Basically, we're using it to replace every paper form around the division and our product returns system (which eventually customers will use as it's all web enabled) along with our change control system.
Gael LtdOrion House, S. E. Technology Park, East Kilbride, Scotland, UK. G75 0RD T: +44 1355 593400 F: +44 1355 579191 E: info@gaelquality.com
Registered Office: 1 Cambuslang Court, Cambuslang, Glasgow, Scotland G32 8FH. Registered in Scotland. Company No. 208191. VAT Registration No. 886 6848 45.
Copyright © Gael Limited.