The second part of a 3-part series addresses quality control and compliant technology systems with risk-based approaches.

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Achieving a Balanced Approach to Technology and Total Quality Management Systems Part 2: Quality Investigation and Management

Quality and The Role of Risk Management

The Quality paradigm is perceived as a set of rules that defines limits and guides to operate inside set boundaries successfully. Conversely, Quality sets trends for establishing a patient-centric and product safety business culture. With greater use of sophisticated technology systems, life science organizations maximize the benefits of quality management systems. Legacy systems are moving towards enhanced paradigms where Quality is combined with risk-based thinking with new technologies to achieve a higher level of compliance. The table below compares traditional and modern Quality paradigms.

Traditional Quality Paradigm

Modern Quality Paradigm

Quality is inspected.

Quality is “built in” the products or services

High Quality requires high cost.

High Quality lowers cost in operations, minimizes deviation and unaccounted quality events investigation efforts.

Procedure-oriented that focuses on the shop floor.

Process-oriented with a focus on the entire organization.

Driven departmentally and siloed.

Leadership is driven across the entire organization and processes.

The modern Quality paradigm, when applied to an organization, brings a pragmatic solution that maintains the core business values, targets, and objectives. Technology systems such as eQMS and ERP software systems enable much of the modern quality paradigm benefits.  However, risk cannot be discounted as it co-exists with basic operational and support processes. As a result, an effective quality system requires risk management, including investigation, to sustain quality management objectives and targets. Software applications can simplify auditing, verifying, and reporting information to regulators.  These systems must be validated and maintained in a regulatory compliant manner. Risk Management is a principle that allows the evaluation of risk scientifically; thus, risks are prioritized and allow for better use of an organization’s resources and capital expenditure.

What Might Go Wrong in a Modern High-Quality Environment? 

The quality management system and its processes address risks and opportunities that lead to effective policies and procedures. The Life Sciences industry heavily relies on risk-based principles to:

  • plan effectively and efficiently
  • perform the planned activities
  • check the effectiveness of the action plan
  • continually identify areas of improvement

Realistically, the life sciences industry experiences daily hurdles that depart from ideal and theoretical. Quality events and incidents happen from the onboarding of new materials and supplier management through post-marketing activities. Failures can be inevitable, but they must be investigated and commensurate with their risk in a regulated environment. The maturity of an organization utilizing a risk-based approach to solving problems is a critical success element in identifying a robust corrective action plan that satisfies regulatory expectations. One way to interrelate risk to failure investigation is by building a process with technology systems in a focused approach to:

  • identify the critical process
  • determine the risk
  • Identify root cause systematically
  • plan the action(s)
  • continually improve

Stepping Forward to Ideal Resolution Management

An ideal combination of experience and modern Quality perspectives are essential to successful compliance management.  How does your organization’s Quality Risk Management balance with your technology systems? Do risk assessments support decisions? It’s critical to align Quality systems with risk-based approaches to minimize compromised decisions.

Speak with our experts. Arbour Group provides regulatory compliant solutions with shorter timeframes to get the results you need.  Access the expertise you need by contacting us for a consultation.