Part 2 of a three-part EQMS blog series
If you’re responsible for establishing or improving your electronic quality management system (QMS), brace yourself for many challenges. One of them, often the most crucial, is obtaining the support of senior management.
Bringing a new product to market entails many risks, especially for life science and other regulated companies. On the average, it takes 10 to 15 years to develop a new medicine and get an FDA approval. A new medical device takes three to seven years to develop, from concept to regulatory approval. For general manufacturers, the time to market depends on the complexity of the products.
Regardless of which industry you belong to, your company’s goal should be to launch your product on time and on budget. An automated, electronic quality management system will help you increase efficiency, ensure compliance, and accelerate time to market. It can also boost your agility in times of disruption and lower the total cost of quality and compliance.
This is the second installment of a three-part blog series focusing on the importance of an enterprise quality management system (EQMS) for medical device and diagnostics, pharmaceutical, biotechnology, and manufacturing companies. This article examines how to gain support management and other stakeholders to support the implementation of an automated quality system.
Common Reasons for Resistance
Aversion to Change: Most executives who oppose EQMS projects cite the high cost of adopting technology as the reason for their resistance. At times, cross-functional aversion to new system adoption tends to slow down the process or reinforce management reservations.
Lack of a Quality Culture: In many cases, the quality team wants to automate existing paper-based processes. It wants an enterprise-wide system that creates a single source of truth. However, without buy-in from the IT department, senior management is likely to resist the plan. Why do IT and other departments reject an EQMS? It’s usually because they don’t feel invested in quality management. They mistakenly believe that quality is the sole responsibility of the quality department.
Unfamiliarity with Compliance Needs: Sometimes, the issue lies between a business unit and its parent company. A division may ask for an EQMS to address specific quality and compliance needs. However, the parent company may insist on utilizing the organization’s ERP or other workflow-based systems that are inadequate for specific compliance requirements.
Before you start writing a project proposal, get a feel for the prevailing thinking and attitudes within your organization. Talk informally to department heads or conduct a company-wide survey. The reasons for possible resistance to an EQMS will be as varied as the different decision-makers in your company. You’ll have to discover the critical factors to tailor your plan. But there are solid reasons for making a case for EQMS adoption, which should be included in your proposal.
Top 4 Business Impacts of Electronic Quality Management System Adoption
These are the four biggest business impacts of a robust EQMS. Make them a central part of your proposal. If you can, gather internal statistics to back your arguments.
1: Increased Efficiency: Companies using manual processes spend a lot of time and effort doing basic tasks. An EQMS automates routine tasks in quality processes, including document control, change control, training management, audit, CAPA, and nonconformance management. Automation can dramatically reduce the number of man-hours devoted to daily tasks. It allows fewer employees to do the same amount of work, so you can redeploy manpower to other areas.
- Standardization and Consistency: With an EQMS, you can standardize all document-based processes for consistency and efficiency. Your teams don’t have to start from scratch each time they create a new SOP or launch a CAPA. Standardization is half the battle for efficiency.
- Centralized Platform: Choose an end-to-end EQMS for a single, centralized source of truth that facilitates search and retrieval of documents. All users and stakeholders will go to only one place for all quality documents and tasks. Likewise, auditors and regulators will be able to find everything they need in one place.
- Integration of Unconnected Systems: Already using electronic systems? Integrate unconnected ERP, CRM, LMS, and other systems for a better EQMS. You’ll be able to optimize usage of existing systems and foster holistic compliance.
2: Informed Decisions: Say goodbye to guesswork in quality management. An EQMS with advanced analytics and reporting tools will help you make informed, data-driven decisions. This is especially critical in resolving quality issues and monitoring any weaknesses in your quality processes. You’ll gain insights into the issues in real-time that allow you to make faster, data-driven decisions.
3: Adaptability: The global pandemic is wreaking havoc on communities and businesses. The new normal that’s currently shaping up requires adaptability. Regulated companies can no longer afford to be shackled by outmoded processes and systems. An EQMS will equip your teams with the capability to work and collaborate in a secure virtual space regardless of geographic location, time zones, and external disruptions. You’ll be ready when the next disruption happens.
4: Lower Total Cost of Quality (COQ): Using manual processes is a financial drain. Labor-intensive processes and disparate systems require more manpower and are less efficient. They can cause errors, delays, rework or low-quality products that ultimately cost more far more than an EQMS. Ask senior management and other departments this question: How much is the cost of not having an EQMS?
You and your team may know all about quality and the virtues of an EQMS, but not the rest of the company. You have to present the advantages of an EQMS with facts and figures, if possible. Try to document existing inefficiencies and quality issues, including how many hours are wasted on ineffective manual processes and the dollar cost of such waste.
More importantly, try to make senior management and your colleagues understand that everybody is responsible for quality. A closed-loop EQMS will help promote an enterprise-wide culture of quality by making it easier for everyone to participate in quality processes.
Read Blog 1 of the 3-Part Series: 5 Reasons Why an Electronic Quality Management System is Imperative
About the Author
Sal Lucido is Co-Founder and Executive Vice President AssurX. Sal is an unequivocal product evangelist and an expert in the area of quality process automation. He holds a broad array of responsibilities, ranging from overseeing strategic plans and operational improvements to managing tactical alliances.