A quality management framework comprises a set of defined objectives and procedures to achieve outcomes compliant with regulatory, customer, and organizational standards.
In simpler terms, a quality management framework is a structured ensemble of policies, documented procedures, processes, records, and their respective responsibilities.
An effectively designed quality system is intended to decrease product recalls and returns, as well as curb market introduction of inferior or flawed products.
Such a system, also known as a customer-centric management approach, focuses on efficiently managing both workflows and organizational functions.
Quality awareness, like any human endeavor, has heightened regulatory expectations in product development. Now, ensuring quality in both goods and services is considered essential:
– Products must be proficient in functionality right from the outset.
– Meeting customer expectations promptly is key.
– Achieving excellence in product development and service delivery is vital.
Regulatory bodies assert that ‘quality should be inherent in the system, procedures, and personnel, ensuring patient-reliable products.’
Today, quality systems can be classified into aspects such as Quality by Design, risk management, change control, deviation handling, corrective and preventive actions, standard procedures, and product recall instructions.
For healthcare entities, every product must meet standards known by the acronym PICS (Purity, Identity, Conformity, and Strength) to ensure safety and efficacy.
Quality by Design encompasses creating products and processes that consistently meet quality standards during development.
Risk management utilizes assessments, controls, and reviews across a product’s lifecycle.
Change control implements a defined methodology for process improvement and ensuring procedural consistency. All modifications are reviewed and approved by relevant stakeholders to assess their impact.
Deviations represent any abnormal incidents diverging from standard protocols and can occur across various stages such as production, packaging, or testing.
Corrective actions seek to eliminate causes of non-conformities, while preventive actions aim to prevent potential irregularities.
A product recall is initiated to remove non-compliant drugs from circulation, with remedial measures depending on the level of threat they pose:
– Class I recalls address life-threatening circumstances.
– Class II recalls involve significant but generally not life-threatening issues.
– Class III recalls relate to minor regulatory infractions.
Resolving market complaints involves product return and quality analysis, with critical adverse events reported to health authorities.
In deviation management, undesirable results initiate thorough lab investigations to identify root causes, typically followed by necessary approvals if the cause remains undetected.
Internal audits are critical evaluation tools within organizations, ensuring adherence to established quality and GMP standards.
Training ensures personnel can competently fulfill their roles, impacting overall process flows and patient safety.
Standard Operating Procedures (SOPs) guide task execution within companies, emphasizing clarity and end-user focus.
The core components of quality systems include compliance, audit and inspection programs, management oversight, and clinical data integration.
The advantages of a quality management framework are manifold, from ensuring structured actions, facilitating organizational competence, promoting clear communication, to fostering an environment for continuous improvement.
Ultimately, a robust quality management framework assures product and service quality, optimizes resource usage, and aligns with organizational growth and compliance objectives.
Periodical management reviews should involve senior leadership to continuously improve quality systems and adapt to new insights.
A comprehensive quality manual should outline these systems, cementing it as a cornerstone of good practices such as GMP, GLP, and GDocP compliance.
*(The author is an expert in quality management systems with a global professional focus.)*