Fit Is Everything: Getting the Right EQMS to Suit Your Organization

More companies are in the planning phase of EQMS adoption than in previous years -  significantly more. This is a journey that begins at disparate artifacts (binders, spreadsheets, repositories, etc.) with a planned destination of a comprehensive enterprise EQMS hub with appropriate integration across other core systems including ERP, PLM, MOM, EHS and CRM platforms.

It signifies the will to bring together people, processes, and technology as the catalysts and culture shift necessary for progress towards Operational Excellence.

Like any journey it would be a mistake to limit options until available modes of transport and routes have been thoroughly evaluated. The EQMS market is breaking through from early adopters to early majority and technology vendors have helped many navigate perils to ensure success and returns. In this post we’ll explore some high level considerations that help secure the right fit.

Familiarity Is NOT Fit

Ironing out bias is a key element. As consumers we constantly both consciously and subconsciously find comfort in a known entity and its perceived safety. Establishing a representative cross-functional team adds check and balances here.

Leveraging previous implementation experience, evidence of end-user adoption or the success of a single facility that blazed a trail with a quality management software solution is important but has potential to blinker and limit objectivity. Positive outcomes for a subset or previous deployment is not a guarantee. This can manifest as trust in a solution and implementer but we should guard against this swinging votes too early in the process.

No solution is perfect but explaining gaps to important stakeholders against a backdrop of having limited selection to a known entity is entirely undesirable and can be very expensive to undo. 

Ask What Constitutes Fit From Those That Have Already Done It

Looking externally for insight is advised. How do EQMS executive sponsors get insight with regard to what their peers are doing and/or have done successfully? Probing peers and seeking out objective reports is a viable and a reliable approach. It isn’t as simple as making a call, though. In our experience senior executives that have made strides towards operational excellence using best of breed tools, and are engaged enough to participate in industry or independent forums are happy to share experiences both good and bad.

You should explore arguments for dedicated EQMS vs. expansion of ERP or PLM deployments to meet the objective. There is a level of trust and openness in these connected and managed forums that promotes sharing in good faith. Cascade these insights across the quality management team and the broader stakeholder group and promote discussion. Buy-in is developed here.

Find a North Star

Solution selection guides are designed to provide a bird’s-eye view of a route to a destination. The kinds of questions answered are stability and longevity of the vendor, industry verticals served and specific regulatory expertise, geographical and multi-lingual capabilities, toolsets & modules for automating key quality management processes, mobile capability, analytics, and more. 

IT Involvement Doesn’t Guarantee a Fit, But it Helps

It is a mistake NOT to engage IT early in the process. Explore the following:

• Delivery options – cloud, on premise, multi-tenant
• Security policies & risk criteria
• Preferences for concurrency, true SaaS or open licensing
• Technology and database platform preferences

Ask important questions like what are typical roadblocks to projects with a similar profile? Asking these questions early may prevent intolerable delays and unnecessary political strife.

IT will bring enormous value to the table but beware, one issue often encountered by the business users is the unbridled desire to build a solution internally with internal resource. One cannot just dismiss this notion, it has some merits and has in some (but not many) instances been successful in meeting many requirements of an EQMS. The buy vs. build discussion has raged and frankly the war has been won in the favour of off the shelf, configurable solutions. Mostly based on cost, ongoing enhancements and support & maintenance. There are exceptions and the validity of certain platforms (e.g. Sharepoint) for some elements of an EQMS holds water. Consider carefully how domain-driven and functionality changes and upgrades will be funded and executed going forward though.

Insight from IT may include baggage of at least one failed, delayed, and likely over-budget system implementation. These scars will help your group fine tune the criteria for selection and guard against obvious mistakes. Understanding the need for federated security, integration points and other mechanisms, reporting platforms and the skills required for successful in house tailored reporting and analytics are some examples.

Establish & List What Constitutes Mandatory – And Stick To It

This is not a list of functionality alone. Yes, HR, organization structure and product data from your ERP being integrated may well be on the list as might document management, audit scheduling and execution and training and competence tracking, CAPA, and CFR 21 Pt 11 compliance but give consideration early to the implementation and subsequent support from the vendor.

Interrogate their implementation methodology and proposed order of deployment. Do you want a turn-key implementation or something of a kick-start plan followed by train the trainer? You might demand at least three references from similar organizations to yours and insight regarding customer satisfaction surveys. Consider what the balance between usability and capability should be for your end-user. Adoption has many facets and getting this wrong could prove disastrous.

Your EQMS will be the "hub" of your efforts to achieve operational excellence and many tangible and intangible benefits will be your yield. Pitfalls requiring special consideration are integration and the configurability of forms and workflows for the automation of key processes. Go deep on these in demonstrations. Be open to alternatives but striking an item off in the present for something road-mapped is a significant risk. You are not their only customer. Having satisfied core requirements, where will the EQMS capabilities take you?  Mature vendors will help you understand and can provide their vision supported by their implementation experience.

Remember, This Is a Journey

You won’t get everything right away, for example, some integration efforts take time and may require intermediate cleansing routines and that’s OK because this is a journey. If you are making this journey with a well-defined and understood map based on overall "fit" and with advice and partners you trust, you will arrive. In time to plan for the next journey, of course.