01.29.2019 Robert Fenton

How to Achieve Effective Quality Assurance Even In the Most Complex Circumstances

Effective quality assurance in highly regulated industries requires the alignment of people, culture, processes, and technology. If you’re trying to create improvement in your organization’s quality management system (QMS), you may be dealing with complex circumstances. Perhaps your startup or scale-up is implementing a QMS for the first time with limited quality or IT resources. Maybe a recent QMS software initiative failed, and you're switching technologies.

Establishing a quality management system which improves quality control and assurance should create significant change in your culture and operations. However, this doesn't mean a simple QMS is ineffective. QMS projects can fail to meet quality standards or expectations for many reasons, but simplicity is rarely one of them.

A quality management system doesn't need to be complicated to improve quality assurance.

An effective QMS can create clarity in a difficult circumstance, while a needlessly over-engineered QMS can damage project results and create employee resistance. The key to delivering effective quality results is to focus on your users, compliance, and best practices.

How to Deliver Effective Quality Assurance with Complex Systems

Ultimately, a Quality Management System software is a framework which enables organizations to consistently deliver on customer expectations for product quality with a framework for quality assurance and control throughout the product lifecycle. A QMS system can provide improvements in product quality, cost management, and compliance by simplifying regulatory requirements and standards such as ISO 9001 or cGMP.

Understanding the purpose of a QMS is essential to avoiding unnecessary complexity which can hinder your quality goals. In many cases, organizations mistakenly perceive QMS as a series of complicated and tedious SOPs which can constrain innovation. To deliver useful results, it's crucial to avoid clouding the real mission of your quality system.

Keep Things Simple

At most highly regulated organizations, the quality unit is a champion for formalizing QMS. Individuals who work closely with quality control and assurance are generally defined with creating an implementation strategy and clarifying roles and responsibilities per industry guidance. cGMP-assigned duties of the quality unit include:

  • Implementing and completing quality controls
  • Developing procedures for operations
  • Ensuring procedures and specifications are followed
  • Reviewing records to correct discrepancies

Regardless of how complex your QMS system may be, the essential principle is to keep things as simple as possible. This means the components of your QMS software for quality assurance such as document control, training, and CAPA are simple to configure and use successfully. Avoid unnecessary complexity or customization if it doesn't serve a distinct purpose.

It can be tempting to create a sophisticated, highly customized system which meets future requirements for standards certification or other goals. However, this is a mistake which can complicate deployment. A confusing system is a barrier to achieving continuous improvement. To encourage active participation and quality gains, configure the system to meet end-user requirements.The Perfect Quality Assurance Plan for Pharmaceutical Companies

Stick to Requirements and Best Practices

When a needlessly complicated QMS is launched at an organization, employees lose sight of quality. Focus can shift away from processes and quality to the system itself as the workforce struggles with adoption. Implementing a new QMS is not the right time to create a drastic change in working habits or expectations, such as designing a system for future requirements for process change.

If you are implementing a new QMS to replace an existing quality system, avoid excessive "features" or "add-ons" without a clear use case. Instead, stick to the key components:

  1. Meet Regulatory Requirements
  2. Adhere to Industry Best Practices

Technological change can disrupt organizations of any size, regardless of whether you're a startup or a small firm with a recently failed QMS initiative. Focus on easing the transition with a QMS which doesn't try to reinvent the wheel.

Related Reading: Quality Management In Healthcare: 5 Things to Expect in 2019

Process Map the System

To optimize simplicity, start the project design phase with process mapping standard operating procedures (SOPs). Creating simple, visual documents can clarify the actual inputs and outputs in your organization. The art of process mapping can educate stakeholders on processes, SOPs, and metrics more effectively than written documents. An estimated 65% of the population learn most effectively from visuals.

To begin process mapping, use a flowchart tool to foster collaboration between process authors and approvers. When you have defined all critical quality processes, you can expand the detail with the use of swim lanes, a visual diagram which outlines roles and responsibilities within a process. Process-mapping can support the design of a QMS system which meets end-user requirements and streamlines QA.

Where Do You Stand on Quality?

Any significant change initiative in the workplace can create complication. When adopting a new QMS, simplicity is key to adoption and yielding improvements in quality assurance.

As highly regulated organizations grow and evolve, the process of segregating work can create growing pains when staff members are used to wearing a lot of hats. Resistance to change can complicate QMS system design and user adoption.

A successful QMS project requires effective change management and an understanding of the role humans play in quality assurance. Disillusioned stakeholders may resist a new QMS. To create trust in a new system, it is crucial to involve the entire workforce in the QMS initiative to instill confidence. Regardless of how complicated your culture may be, a new QMS solution can drive improvements. By focusing on simplicity, best practices, and effective change management, you can take advantage of the opportunity to start anew.

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Published by Robert Fenton January 29, 2019
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