What are you looking for in an automated quality management system?

[savantrep]

First off, I've been a long time Elsmar visitor and probably would not have made it anywhere in my career without the knowledge and insight of all of you. I'm a quality engineer by trade and have held positions in aerospace, medical device and general manufacturing.

That being said, I decided that since I really enjoy developing software and my background is in the QA field, I would like to give back to the community. I'm currently working on development of my own SaaS solution for AS9100, ISO 13485 and, of course ISO 9001 compliant QMS and would like to hear your feedback. What do you want to see? I'll give you a rundown of what I have so far:

Modules:
Document Revision & Control
Training
CAPA/NC management
Customer Portal (Complaints)
Supplier Portal (SCARs & Scorecards)

Software:
This is a web application based on the Twitter Bootstrap with plans for a native iOS/Android app in the future.

Pricing:
Current plan is $500/m subscription which includes unlimited sites, users & modules.

So - people of Elsmar, QA professionals, newbies, everyone - what else should this system have/do/be capable of? What is missing in current QMS programs? How can I make an amazing product that you would want to use at your company?

Thank you all for taking the time to provide your thoughts on this. If you have any questions, please let me know!

-Ben

 

[ScottK]

Hi Ben.
I've been in the market for eQMS before so I can give you some ideas of what I look for:

- 21 CFR Part 11 Compliance
- A validation package provided by the vendor that I and my team can execute
- Customization of fields
- Choice of modules - say I only want an incident management system for NCR and CAR - will I have to pay the full subscription or can we scale back?
- Ease of use
- Ease of conversion
- Training - and I can't overemphasize this. GOOD training for users and super-users.

 

[stevegyro]

What I have always wanted is an "information product" to keep every principal department (in your firm) communicating 100.% of the message, 100.% of the time. IE. at least keep these people in-the-loop: Lead machinist, foreman, Value Stream, inspections/Cmm, SPC engineer, quality engineers, mfg. engineers, customer tech support ....


In my experience I have seen engineering making changes to OP sheets, but where other key players are not informed immediately.

You have machinists not giving feedback (i.e., to the net effect of a process change, or the supervisor/engineer not listening (this is more common!)

How does your firm handle change?

Thanks,
Steve G.
Spc Engineer / QE.

 

[savantrep]

Hi Ben.
I've been in the market for eQMS before so I can give you some ideas of what I look for:

- 21 CFR Part 11 Compliance
- A validation package provided by the vendor that I and my team can execute
- Customization of fields
- Choice of modules - say I only want an incident management system for NCR and CAR - will I have to pay the full subscription or can we scale back?
- Ease of use
- Ease of conversion
- Training - and I can't overemphasize this. GOOD training for users and super-users.

I hadn't thought about including a validation protocol! I know there is difficulty in this because everyone's requirements are different, but I'm sure I could make something generic and customizable enough to work for most.

Also, I've thought long about training. I think videos showing how everything works, including the data structure and process workflows would help. I'm also including "tooltips" in the design so that when a user hovers over a field or bit of text, an explanation is given.

Thanks for the great ideas!

 

[savantrep]

What I have always wanted is an "information product" to keep every principal department (in your firm) communicating 100.% of the message, 100.% of the time. IE. at least keep these people in-the-loop: Lead machinist, foreman, Value Stream, inspections/Cmm, SPC engineer, quality engineers, mfg. engineers, customer tech support ....


In my experience I have seen engineering making changes to OP sheets, but where other key players are not informed immediately.

You have machinists not giving feedback (i.e., to the net effect of a process change, or the supervisor/engineer not listening (this is more common!)

How does your firm handle change?

Thanks,
Steve G.
Spc Engineer / QE.

This is an excellent point. Communication is key. And yes, there are systems that send email notifications - which this would be able to do. But how many people ignore those, delete them or just forget about them? They also aren't tied to any action, so the feedback loop is incomplete.

I'm building a system that requires certain users or user groups - say Engineering, QC lab, Procurement, etc.. to sign off on a document revision, or other "thing" such as a CAPA,. In my design, this is a document review and the document cannot be revved until each authorized electronic signature has been made. To your point, the summary of changes could be broadcast in real-time on the front page/dashboard.

There are also collaborative tools for root cause and risk analysis that will require interaction/feedback/communication between stakeholders.

Thanks for the great idea - this really got me to think.

 

[RCH2016]

I would suggest adding calibration recording. We are using Qsi presently (working on ERP) and I have always thought that it might make sense to combine CA and customer complaints. Also, I would like to limit who can enter CAs, and instead have an option to PROPOSE a CA, much like they can propose a change to a SOP in Qsi.

Just my 2 centavos.

 

[Mark Meer]

...
- 21 CFR Part 11 Compliance
- A validation package provided by the vendor that I and my team can execute
- Customization of fields
- Choice of modules - say I only want an incident management system for NCR and CAR - will I have to pay the full subscription or can we scale back?
- Ease of use
- Ease of conversion
- Training - and I can't overemphasize this. GOOD training for users and super-users.

What he said.

For a full electronic system, 21 CFR Part 11 is a must. Integrated right into the software would be a great selling feature, as presently a lot of companies have to pay for additional 3rd-party applications for electronic signature support.

I'd add:
- Flexible backup capability to at least PDF and CSV
- Way to quickly link/access related files, and check validity of references.

This second thing is what I really appreciate about wikis. References to other documents/records can be hyperlinked directly in the text, and the wiki will automatically inform if links are broken.

 

[stevegyro]

Yes, your comments about emails getting ignored is very true! We have never had more ‘smart portable’ devices in history, yet we still ‘need’ to have meetings to get everyone informed, and to ‘zap’ tasks falling behind.


As a former programmer, and now a QE having worked at a few companies, is the ERP conundrum... ERP’s tend to be expensive, complicated, and usually only 1-3 people are trained well enough with them to make good use of them. Little ‘silo stuff’ going on here as well. The better ERP’s have modules for QA and QC, but I have yet to see any company spend the extra dime (x 1 million) to install, train, and utilize effectively.


I am not the sharpest stone on the beach, but I am pretty good at predictions. My dad was really good at predicting, even knowing the importance of William Deming back in the early 80’s.


Here is the future, and for the gentleman whom wants to make a custom eQMS system, a word of caution:


IMHO: A custom eQMS system (ie from scratch) will neet to be able to ‘talk’ to the ERS system. Which ERS is most flexible? Open source?


A tough decision! because every (ERS) product has a life cycle, you don’t want to be over dependent on one ERS company, if they ‘close shop’ or stop supporting an earlier release. FMEA this concept, to save heartaches later on.


I know little about inner workings of ERS ‘major players’ in today’s marketplace, but if you can find one that is ‘open source’, with documented code, I would take a hard look at that.


This leads to a final point:


AI artificial intelligence is around the corner, SO you want to make sure that when India or a US software developer applies AI to ERS and QMS, you do not want “TO BE ON A PLANE WHEN YOUR SHIP COMES IN...”


What would impress me is a firm (or two) that specialize in training and customization, to maximize day to day use of that ERS system.
Look for common modes, such as two out of four of the most used ERS systems use “brand X” coding (ie Python and or Access), and test-balloon a module.


Training the customer, like one or two posts earlier, is value added.
If your (manufacturing customer) wants to ‘cheap out’, educate them better on the realizable benefits. Educate their competition too. When they start ‘biting’ and realizing rewards, many will follow.


The American Dream! Best regards - Stephen Giarratana SPC Quality Engineer.

 

[kzachawk]

There are a gazillion pieces of QMS software in the market and one more makes it a gazillion + 1.

After being in the field of manufacturing for over 30 years, its my observation that most software fails in two ways.
1. integration between existing software packages
2. Capability to manage variation, and or changes, especially the inclusion of workflow

Build a software package which allows these functions to integrate with existing MRP and Enterprise solutions and industry will be very interested indeed.