#Quality13: A Checklist for Enterprise Quality Management by ComplianceQuest

OVERVIEW

We created this checklist with a vision of sharing our expertise in the area of Enterprise Quality Management Systems (EQMS) with entrepreneurs, business leaders and, more specifically, quality leaders around the world.

We believe ticking-off this list will certainly help transform your organization’s efforts in the area of quality and compliance and will help drive strategic advantage for your entire business process and operations.

HOW TO USE THIS LIST

All 13 points on this list will be fairly obvious to most business leaders. The purpose of this checklist is three-pronged

• Make sure you tick-off all 13 points ;
• Ensuring ‘Continuous Improvement’ across all these 13 aspects;
• Helping you implement an enterprise-wide quality management culture through technology

1. Do you have an EQMS Solution that is automated, with collaboration features?

How are you currently measuring quality events and metrics within your organization? Is it on an Excel sheet? Are you using a SaaS tool or on-premise software to track quality and compliance parameters? A common mistake is to have the quality system operate in a disconnected fashion and not in sync with the rest of the business process. And, this certainly needs to be fixed. The first step to drive digital transformation of your quality management process is to conduct an audit of your current state of processes and quality data.

You need to ask yourself questions about the reality of your quality management system:

• Are key data and metrics in place?
• Is your process and system efficient or is time being spent on redundant or unnecessary activities?
• Can you get a complete vision of the state of quality and compliance across your entire organization?
• Are you missing critical data because your processes are manual or your electronic systems do not speak to each other?

Recommendation: Conduct a quality operations and IT Data audit. Perform an Analysis on the results identifying the biggest gaps and suggestions for corrections both for process and systems.

Your goal must be to deploy an Enterprise Quality Management System (EQMS) that is connected, data-driven and deployed on the modern cloud, having the benefit of more connected systems.

2. Are you measuring everything you want to measure?

Your goal must be to identify and design a Quality Management System that measures all key quality events and metrics. This could include all regulatory needs, key data points across the value chain, your customer lifecycle data, supplier management software, CAPA, Document Management, and several other areas.

Needless to say, the quality metrics will vary as per your sector and is unique to every business. Designing and solutioning the entire quality system is key.

3. Does your EQMS solution have a customized dashboard, with configurable reports and analytics?

Once you have the specs for your EQMS, the next step is to design your Dashboard and Reporting System. We suggest this top-down approach for configuring your EQMS. This obviously has to trickle down to modules and sub-modules, but a top-down approach helps you stay focused on the key metrics you’d like to measure.

4. Is your system ‘Designed for Quality’? Or, is it an afterthought?

The role of design thinking has become mainstream across several industries. We’ve added this question to the checklist as a reminder item! Is quality and quality management an afterthought? Or has it been embedded into all processes?

To make sure your EQMS is robust and complete, we suggest a unified integration effort across your business process.

5. Do you think there are ‘Gaps or Loopholes’ in data gathering?

This one is only an extension of the previous point on ‘designing for quality’. But, we highly recommend one more simple step while configuring your EQMS. Spot gaps in your data gathering process, and codify your EQMS accordingly. We’re digitizing for a reason, might as well ensure completeness of the process.

6. Are you happy with the quality of your EQMS system currently?

Once the EQMS is implemented, inspection and regular audits are part of the business process. Our experience at ComplianceQuest is that there is always room for improvement and gap-fixing. A methodology to drive continuous improvement is critical. This point is almost ironic! We’re essentially suggesting a quality management process to make sure your EQMS is of high-quality.

7. How automated is your quality and compliance process?

At ComplianceQuest, we have deployed our EQMS across several sectors including e-commerce, medical device, healthcare and life sciences, financial services and manufacturing. They key to derive strategic advantage from your EQMS is to automate improvements into the system. For example, if your Supplier Management system has quality gaps, how can these be spotted automatically? Does your system track product quality defects, and therefore improvements by supplier? It is a critical aspect of a proven EQMS solution.

The role of automation is never-ending and it certainly helps to use an EQMS on a Modern Cloud, so newer features and product innovation are seamlessly deployed.

8. Does your system enable easy ‘Action & Change Management’?

Of course, all action based on quality metrics can’t be automated. Your EQMS platform will certainly have a CAPA Module that helps you take meaningful action and track progress. At ComplianceQuest, we constantly strive to enhance our CAPA and Change Management Software Modules, to deliver continuous improvement.

9. Is your EQMS designed to draw key strategic insights?

The biggest benefit of using an EQMS is to derive insights from Big Data and Analytics. When you Design for Quality, you’re also striving to build a Insights Engine, to learn from key metrics and take action accordingly. While digitization certainly helps with access to data and insights, it is upto the business leader to derive strategic benefit from these insights.

10. Do you have visibility of quality data across the entire value chain including supplier and customer communities?

You may have noticed already that this checklist may be somewhat repetitive. But, the idea is to ensure completeness without leaving any stone unturned. The concept of ‘Connected Quality’ is simply this: Non-compliance or Defect spreads across the entire system. Therefore, your EQMS must help spot the cause of quality lapse and prevent its spread.

11. Does your system have the ability to trace Non-Conformance & Assign Ownership to take Corrective Action?

Again, an extension of the previous point. Your EQMS must automate traceability of non-conformance, and transfer ownership to the relevant person in your organization.

12. Does your EQMS enable collaboration?

Some of the best reviews we’ve received from our clients revolve around how ComplianceQuest’s EQMS helps deliver collaboration amongst teams. This is really core, since ‘Quality is Everyone’s Responsibility’ as W. Edwards Deming once said.

13. Is your EQMS built on the real cloud? And, is it affordable?

Needless to add, the cost of running an EQMS solution must not be prohibitive. A cloud-based interconnected platform with a SaaS-based business model is highly recommended. Moreover, your EQMS will be extremely secure if it is built from the ground up for the cloud. While there are a number of “cloud washed” systems in the market, it is important to have an EQMS that is secure and digitally connected, and that is possible only on the “real cloud”.

Please do request for a demo of ComplianceQuest, a next-generation EQMS built on the Salesforce Platform. We’re a Summit Partner of Salesforce (highest level of ISV partnership possible), with deep experience of serving customers in manufacturing, life sciences, pharma and biotech, consumer packaged products, hi-tech, automotive and aerospace sectors.