Advice and software recommendations please.
Greg White
7 Posts

Hi all! I was hired in December by a midsize but rapidly growing manufacturer after a 3 year absence from Manufacturing/Quality. I have been tasked with designing, building, deploying, and managing a QMS where one has never existed. I did this with a small manufacturer back in 2005 and was easily able to create, deploy, and manage the QMS “manually” for 14 years. That isn't going to work here. I am looking for advice and recommendations for QMS software. Thanks.

13 Replies
For more context, I would ask, what are the regulatory standards you are beholden to? Are they ISO, or CFR, or NQA, etc.? List them all. I don't think there is a general software that could cater to all of the varied industries. Perhaps I am wrong.

(Side note: I have crafted many QMS procedures, work instructions, standard test methods and forms and would be willing to assist offline)
Greg White
7 Posts

@Shawn Varela
Hi Shawn. Thanks for the response. The previous QMS that I built and managed was registered to 9001 for 14 years. I will be eventually be seeking ISO registration for this new QMS. I am designing/building this system to be compliant, so when the time comes, it should be a smooth transition. I purchased a comprehensive Quality Manual template and the 9001:2015 standard. I am working on the procedures and work instructions now. It is a new industry to me, so it is very slow going (learning the product and processes). Ownership is being patient and appears to understand that this is not going to come together quickly. I am 7 weeks in and it is not coming together fast enough for me. It has also become obvious to me that I am going to need the assistance QMS software for management of this system. Thanks for any advice and/or recommendations.

Hi Greg,

I have drafted a QMS-SMS-LMS strategy in a whitepaper - you can review at https://www.picsllc.net/items. It is an integrated management system through platforms and tools. We can consult on an individual basis to help tailor using any existing software in your company to help you perfect it to support the QMS.

Kindest regards,
Harry
412-525-2847 cell
I am working with a small company and we deal with papers for almost everything - go paperless as much as possible whatever that takes. Here it meant having network and database access throughout the manufacturing process and purchasing licenses for our QMS software at each computer. An additional expense but the management here is willing to and supportive of quality improvements. Paperless makes presentation to auditors much easier and shows commitment to quality by top management, not to mention revision control of documents.
John Cachat
12 Posts

@Greg White Harrington Group has great QMS software - you can view at


Happy to have a call to discuss your needs - John Cachat

Greg White
7 Posts

@Harold Rice
Thank you!

Greg White
7 Posts

@Thomas Bennett
Thank you!

Greg White
7 Posts

@John Cachat
Thank you! I recall consulting with Harrington years ago.

@Greg White
Hi Greg,

congratulations on your new role, If you are looking for a software to help manage documents etc, there are may out there, some are better than others. There is Qualtrax, Safety Chain, Redzone compliance just to name a few, i have used them all, i find Qualtrax to be better suited to me because it was easier to navigate, facilitated work stream approvals, it allowed for the use of the document while the document is under review, track changes to documents, who made the changes and when, as well as automatically assigned version numbers. The others mention do have some of the features i mentioned.

If you are looking for one to manage use to collect data then check out QAD Redzone, InfinityQS, Matrix Software Solutions.

Greg White
7 Posts

@Christopher Baptiste
Thank you Christopher!

Hi, @Greg White

I'd be curious to know more about your requirements. It's not full-blown QMS by any means, but if it looks useful for the procedures / work instructions you mention (along with associated activity records), I'm happy to show you TaskTrain.

Hi @Greg White

I am working on something similar. However, my project is more of a thorough update than creating something from scratch. My first piece of advice is to separate, at least in your mind, what you need in your Quality Management System (QMS) from thoughts about your Quality Management Software (QM Software). I spent too much time figuring out that I need to specify the QMS (system) first and then have the software serve the needs of the system. It can be easy to spend time thinking about all of the things that the software can do, write the system around your favorite software, and miss basic needs.

Once the QMS is firmly grounded and outlined, then figuring out the software musts and wants is more straightforward (but not easy).

Cheers!

Tim

Greg White
7 Posts

@Timothy Whetten
I understand and agree. Thank you Tim!