When do you need a QMS application?
What is a QMS software?
QMS (Quality Management System) software is a kind of business application as the other well-known acronyms like ERP, CRM, PLM etc. A business starts this digital adoption journey as it grows and usually from ERP (Enterprise Resource Planning) which core formulates manufacturing accounting as well as operation activities like production planning. Then as the complexities of changes from bill of material by affected items and interchangeability and associated dispositions, PLM (Product Life Management) would follow and be introduced upstream. And in another direction, CRM (Customer Relationship Management) might also be built in order to take care customer’s needs from cradle to grave.
A QMS software usually is composed of several modules which plays some quality functions individually or links each other or even being capable of integrating with other applications mentioned above. The most popular modules include:
-DCC (Document Control Center)
-CAPA (Corrective Actions Preventive Actions)
-Audit
-Supplier
-Training
-Dashboard
And in fact, these functions could be already embedded in either ERP or PLM. For example, because of the revision feature and workflow, you could execute most document control functions like initiating, reviewing, distributing and archiving document in most PLMs. You can also issue and publish Quality Alert or Quality Notification in the QM modules of many ERPs. There are also some quality related functions like inspections which are part of ERPs but less addressed in delicate QMS as its nature to be part of manufacturing process. Supplier quality performance is also available by ERP but might not be on top of ERP consideration. In general, most of functions of today’s conventional QMS are not brand new but the way they work in other business application are not quality function oriented so the market of QMS suite lives.
There are many different solutions in the market now, from full features coverage ones like MaterControl, or Trackwise from Sparta Systems to some lightweight ones like ARMATURE Solutions Corp. and BPA Solutions SA which I touched before. Even you can find open source QMS softwares today.
Which Wins: Open Source QMS Software vs. Subscription? [5 Pros and Cons] (qualio.com)
What are the considerations when you look for a QMS software?
The ultimate goal of a QMS software should be helpful to improve quality of your organization by efficiency and effectiveness, so there is no perfect one which fits all. Your organizational culture and workflows decide how this new tool which is a piece of missing puzzle should look like. There are a few things to evaluate in addition to the quality functions provided:
- How’s the level of paperless environment of your organization?
Digitalization of documents is usually the starting requirement to introduce the DCC module from a QMS software. Surely paper is probably the most handy medium from human history and you don’t need any hardware like display to work, however it’s not friendly to environment and difficult to distribute and control in an efficient way. So if your organization has started the journey of digitalization of documents by collaborating and sharing files by tools like Microsoft OneDrive or Dropbox, it’s time to think about other practices like digitalize your CAPA process.
2. Have your organization adopted digital workflows or systems available for other business applications?
The CAPA process starts from a non-conforming event, either a customer complaint, audit finding, or inspection rejection. Is it an outcome from other applications in your organization today? Does your company have CRM or ERP to record such incidents already? If so, then it’s better to build and link your QMS with these softwares seamlessly and automate your CAPA process. If not, it doesn’t mean you can’t have your disconnected QMS but you have to consider the duplicate entry effort among different systems.
Also the CAPA process usually ends by actions taken which could be a design change by engineering change notice, modified assembly working instruction, sorting or rework of a batch of goods or revision of a quality document, etc.. All things above related to some other activities might happen and record in other systems or modules, and if your QMS can track and validate it in an effective manner and forms a closed loop corrective actions.
For example, when a customer concern in CRM is resolved by issuing a RMA, and if RMA is generated and defect goods received in ERP, then a risk assessment workflow initiated with this field concern by defect severity, defect frequency as well as the service life dimension which are the components of risk scores multiply. If the risk evaluation result is to take corrective actions then if it’s either design or process related, a change request starts in PLM or DCS and the release of change notice or document revision would be amended by relationship with original quality incident in QMS.
3. If you organization has setup a data driven continuous improvement culture
There are many data generated in the manufacturing processes or inspection routines like the yield rate by different buckets or measurements. Usually those data are stored by ERP or MES (Manufacturing Execution System) or even simply Excel worksheets. How to explore and analyze the data to find the improvement opportunitis would be an essential function of QMS when you consider one. These dashboards should be relevant to metrics like quality cost, warranty data, manufacturing loss by labor and material, and receiving performance by suppliers, etc. And if these data could be helpful in analytic design quality.
There are some other reasons like regulation requirements when you consider a need of QMS. Integration to your overall management system would be essential as a key successful factor. How to get what you want with less effort is another important requirement when you make judgment. And as the technologies of artificial intelligence matures, we have seen QMS with NLP or anomaly detection functions applies to automate workflows and these features would require the awareness and knowledge from the organization so correct understanding and explanation to the result is available.
Finally the QMS can only facilitate your quality processes but the improvement of quality still accounts on the organizational knowledge as well as the culture set and led by leadership team.
The mission of GLInB is to bring most value by virtualization of your supply chain quality function to fit for challenges in today’s business environment.
