CQ Guide: Looking to Automate Your Quality Management System (QMS)? Here are 5 “dos and don’ts”

Need for a Modern QMS

Today, businesses are working towards accelerating their digitization efforts to improve productivity, efficiency and facilitate remote working without compromising on product quality, employee well-being, workplace safety, and regulatory compliance.

This requires greater visibility into all key quality metrics across the entire lifecycle of the product or service being delivered. Your company needs a system that can integrate all your enterprise systems bringing together workflows across internal operations, customer processes, supplier processes, etc.

In short, what you need is a highly effective, cloud-based, enterprise-grade quality management system (QMS) that helps close the automation loop when integrated with the company’s ERP and CRM.

High levels of quality control, enabled by data and dashboards, can deliver a competitive advantage to your business – improving customer satisfaction and catalyzing revenue growth.

However, just hold on a bit before you start looking for an EQMS solution. Become aware of the “dos and don’ts” for selecting the right solution for your organization so that you can truly benefit.

Five Dos and Don’ts While Implementing a QMS

#1: Get Buy-In

Do: Involve Everyone from Top to Bottom

We know a quality management system is a “must-have”. We also know it can accelerate growth. We know your competitors are already investing in solutions to improve their processes. These are good enough starting points but not enough for making the investment in a QMS solution. As a quality leader, you can see how a QMS can really effect changes for the better.

But that’s not enough…

For a QMS to be truly effective for your organization, it is essential to get the participation of your entire organization or, at least, all key stakeholders and team members. These people will become cheerleaders for you to build a quality-first enterprise.

Quality is not an isolated function. Unless the top management is involved, the employees will not be motivated to sustain the changes it requires. And if the employees are not prepared, then a solution alone will not make an impact.

Therefore, make sure you make the right pitch that can communicate the effectiveness of and the need for an EQMS to meet your quality and growth objectives.

Don’t: Be Deterred by Costs but Evaluate ROI

Often, the cost can be a deterrent. However, an investment in digital transformation and automation will pay for itself very quickly. To cut corners, management may try to stand by the traditional manual systems that may have served well in the past. But today, it is ineffective because data does not roll up across the enterprise. If processes are not automated, it is impossible to have a collaborative culture to ensure quality.

Specifically, here are some reasons why a manual system will not work:

• The complexity of the business environment has increased dramatically. Action in one part of the organization has a repercussion in another. Keeping track of the cause and effect, root cause analysis, and corrective and preventive action can be very difficult.
• A change in any process needs risk assessment to predict the impact it will have downstream. An automated system will present multiple scenarios which a human mind cannot conceive or assess accurately.
• Traceability has become essential not just for compliance but also to ensure there is no hidden time bomb ticking away amongst your processes. Reporting issues also requires supporting documentation, which a next-generation EQMS can generate automatically.
• Time to market has shortened and any delays will add brownie points to the competition. Automation can reduce waste of materials as well as time and improve processes to meet shorter life cycles.
• ISO, the generic regulatory guidelines for all industries, prescribes an automated quality management system for overall improvement in quality and processes.
• Manual systems are also vulnerable to errors caused by humans, making them unreliable.
• When a complaint is registered by a customer, informing all the related departments, following up on action, and responding to the customer can be challenging. Even ensuring that action is taken requires constant follow-up. An EQMS system keeps track of it for you, ensuring that it is handled well and any future occurrences prevented.

#2 – Spot Gaps in Your System

Do: Set Metrics and Measures

Quality leaders, key business unit heads, and decision-makers should get together to conduct a gap analysis and identify the objective(s) for your quality journey. This will help prioritize the quality effort so that it can be meaningful and result in the desired outcome.

The next step is to establish the metrics and measures. Quality in itself will mean nothing unless it results in something meaningful and measurable. ISO and all regulatory standards stress the importance of metrics to measure the impact of your quality efforts.

It could be any of the following:

• Delivering customer value and customer delight
• Lower costs by improving the efficiency of operations
• Meet regulatory and compliance requirements
• Adopt a data-driven approach to quality
• Digital Transformation and automation of quality processes

Don’t: Forget to Prioritize

Do not try to do everything at once but prioritize goals. In an enterprise, there are many functions that can benefit from the implementation of a QMS. But, setting priorities will help define objectives and have a focused approach to process improvement for greater organizational efficiency and growth.

For instance, if supply chain management is the weakest link, then that should get attention more than anything else. Therefore, choosing a modular QMS solution will help in making the solution cost-effective and facilitates resource optimization.

#3 – Document Objectives

Do: Identify Desired Outcomes

Overall, the EQMS you pick must help you reap the following benefits:

• Build a data-driven quality culture
• Integrating quality efforts across the enterprise so it becomes collaborative and unified
• Improving your document and change management
• Complying with the regulatory requirements as per your sectoral requirements
• Getting a single source of data from across functions for a comprehensive view and for quick decision making
• Automating corrective action, preventive action
• Handling customer complaints to their satisfaction
• Managing the supply chain for improved compliance across the board
• Managing equipment, inspections, and audits with efficiency

Don’t: Compromise on its Future-Readiness

As an organization, your objectives will keep changing depending on your growth, the markets you cater to, the industry in general, and the regulatory environment. Therefore, we believe that the future of quality management revolves around the following five guiding principles that will help drive quality excellence. The principles on which a next-generation EQMS is built includes:

Principle #1: Core Quality Promise – Enabling critical business decision making

Principle #2: User Experience – Simple, seamless, and consistent

Principle #3: Data at its Core – Single source of truth

Principle #4: Standardization and Flexibility – Modular, cloud-based, best practices driven and capable of being tailored

Principle #5: Continued Improvement – Across quality, business process, systems, design, and people

#4 – Does the QMS fit into your Process?

Do: Implement a Configurable Solution

The qualities of the EQMS you seek will vary depending on the size and maturity level of the organization. A large enterprise may need a highly configurable EQMS and so an off-the-shelf solution may not be apt. The EQMS company you decide to partner with must have the ability to offer customized solutions and support. The Quality Management Software must fit into your existing workflow, not the other way round. Most importantly, it needs to have the capability to integrate with your ERP and CRM. Needless to say, as a large company, it is important to have proof that the EQMS vendor has served other large players in your sector.

On the other hand, a startup or a small business may prefer an off-the-shelf EQMS, but it has to be flexible and scalable in the long run. A smaller startup may adopt an EQMS for only one purpose, say complaints handling or audit management. Over a period of time, other solutions can be added. Also, a pre-built workflow for compliance standards – say, ISO 13485 if you are a medical device startup – will be extremely handy.

You must therefore consider factors such as:

• The current scale of your operations
• Your targeting growth and the resultant scaling up
• Your current problems and future problems as you scale-up
• Payment model and how scaling will impact that
• The cultural match with the EQMS vendor
• The size of the companies they work with

Finally, the solution should help you mitigate quality risks with confidence, generate unique predictive insights that result in the prevention of major quality faux pas. While making the life of the quality leader easier, it should also facilitate the organization’s pursuit of quality excellence and continuous improvement.

Don’t: Go for Systems that Don’t Integrate easily

A well-designed EQMS is supposed to integrate with the organization’s existing ERP and CRM systems to ensure the automation of quality and compliance across the organization. This includes internal processes, supplier management, logistics, and all customer-centric departments.

By linking an organization’s key processes end to end, the EQMS provides you with a unified view becoming the single source of truth for all quality data. This view enables making informed decisions based on facts. More importantly, this data is available in real-time to all key stakeholders.

A good EQMS also comes with dashboards and reports for predictive and proactive analytics, letting you capture trends and devise strategies for future growth. The next era of quality and compliance will be data-driven and therefore the need for quality analytics is paramount.

A next-generation quality system will help in identifying trends and patterns, based on enterprise-wide quality data. This enterprise-wide data is available only if your EQMS is truly integrated with your ERP and CRM.

#5 – Evaluate Cloud vs. On-Premise

Do: Evaluate the Pros and Cons of Both

The world is shifting to next-generation software built on the real cloud, and so choosing a cloud-based system is highly beneficial. But it is important to analyze this from your organization’s perspective.

Pros of both deployment options

On-Prem	Cloud
Higher levels of Data control Easier custom development and adaptation if you have dedicated IT teams Security aspects under your complete control	Flexible & Scalable Lower total cost of ownership OPEX / SaaS Model, easier to realize ROI quickly Higher mobility & data visibility Access to technological innovation Easier to shift vendors EQMS partner takes care of upgrades, security patches, etc. No need for dedicated IT teams for support and customizations

Cons of both deployment options

On-Prem	Cloud
Higher cost of ownership and maintenance (CAPEX is high) Longer implementation times Changing vendors will be expensive Needs dedicated IT team to manage infrastructure, maintenance and software upgrades	Annual subscription fee that can go up with the number of users and newer solutions added Data security lies in the hands of the EQMS provider, so you don’t have control

As you can see, both have their advantages and disadvantages. Which one works is a decision you will have to make based on what your objectives are. If you decide to go with the cloud, you may have to evaluate the benefits of going with private, public, or hybrid cloud.

The public cloud works on a multi-tenancy model where the resources are shared by multiple organizations leading to more efficient, scalable, and cheaper options. The maintenance is by the EQMS service provider and if you wish to have control over data, then it may not be what you are looking for.

With a private cloud, you can ensure its security features are as per your policies and also will find it very flexible to meet your requirements. However, the TCO is higher as also the effort required for its upkeep.

A hybrid model is a mix of private and public clouds. It is scalable and secure, but it is more complex and requires greater management. The type of cloud you want to opt for will depend on your need and budget.

Don’t: Forget Scalability and Flexibility

Scalability and flexibility are absolutely essential aspects to evaluate very carefully while choosing an EQMS.

• It should be modular to allow you to invest only in those solutions you need today. For example, your company may need audit and inspection management modules today. Over a period of time, you would like to add complaints handling and CAPA. A truly flexible EQMS solution makes it happen with ease.
• It should be scalable, allowing you to add users without having to invest in additional infrastructure or a new system to accommodate them. It must be seamless to add new users, remove users and add new locations.
• It should have multilingual capabilities to integrate your suppliers from other linguistic regions of the world.
• It should be configurable, allowing users to customize the system based on the evolving market and organizational needs.
• It should ensure compliance to the standards relevant to your business and its evolving needs. In some cases, pre-built workflows for industry-specific compliance standards should be available off the shelf.

The system should be future-proof, built with next-generation features including easy access to quality analytics, AI/ML and NLB-based predictive insights, dashboards and data visualization features. It must be mobile-ready, so key quality events can be tracked anytime, anywhere.