Maturity matters—especially when it comes to your quality processes and systems
Quality maturity plays a key role in both the FDA Center for Drug Evaluation and Research (CDER) Pharmaceutical Quality for the 21st Century initiative and the Center for Device and Radiological Health (CDRH) Case for Quality initiative. But how can a quality system be assessed for maturity?
Here’s what we’ve discovered.
What Does “Mature” Look Like?
The overall maturity of your quality system depends on the maturity in each of three operational layers:
- Quality control
- Quality assurance
- Quality management
In a mature quality system, each layer has clear, well-defined processes and responsibilities. Information and data move between layers in a rational, predetermined way, triggering cascading evaluations and actions.
However, maturity in one layer can mask signs of trouble in another. Knowing which red flags indicate immaturity at each level can help you pinpoint and correct such problems
Qualiy Control Maturity
Quality control describes the steps that are taken to make sure that only product that complies with the approved/accepted specifications is released for subsequent use or processing. In a mature quality control program, you can:
- Consistently identify product that is nonconforming or out of spec.
- Quickly escalate captured quality data to quality assurance decision-makers
- Accurately determine both root cause and necessary corrective actions
- Identify any issues with equipment before they affect product quality
Warning signs of an immature quality control program include:
- Failure to identify product quality issues before market impact
- Inconsistent classification of product quality issues
- Significant equipment failures that harm product quality and escape detection
An unusual or unexpected distribution of complaints across batches, ranges or sites can indicate problems with process variation or process control. By comparing the Standard Deviation and Mean of Complaints per Batch for a product, insight into the suitability of process and product control can be ascertained.
For example, the Standard Deviation being greater than the Mean would indicate some batches having complaint counts potential two, three, even 10 times the complaints count for other batches. That sort of complaint-by-batch distribution would suggest failure to identify nonconforming product prior to release —a sign of immature quality control—or allowing nonconforming product to be released—a hallmark of immature quality assurance.
Quality Assurance Maturity
Quality assurance not only supports and enables production operations but also handles and responds to quality control escalations. In a mature quality assurance program,
- Quality control issues are consistently addressed within risk classes.
- Reportable product quality issues are identified and promptly escalated, as needed.
- Quality control escalation is reported to the appropriate agency in a timely fashion.
- Investigations result in determination of a true root cause and actionable corrections.
Immature quality assurance results in less-than-thorough investigations and misidentification of both root cause and appropriate corrections. Product quality issues result in variable outcomes and are under-reported to the responsible agency.
To identify an immature quality assurance system, watch out for the following:
- Over-classification of records, which can suppress the identification of trends and relationships, leading to ineffective CAPA or repeating product quality issues.
- High rates of root causes related to “human” causes – User operator training, procedure incorrect or not followed and similar root cause categories may indicate inadequate training that doesn’t differentiate between qualified and unqualified personnel and doesn’t prevent unqualified personnel from handling product or making decisions.
- Frequent revision of procedures and other documents, which may suggest trial-and-error “development” of SOP, test methods, batch processing instructions and other reference documents.
- Rapid onboarding of new hires, with irregular training completion and per-day SOP read rates.
- Large volumes of Planned Deviations, a greater than expected ratio of processes with planned deviation (or temporary change control) compared to processes without planned deviation.
Quality Management Maturity
Quality management ensures that adequate resources are available for the production and control of quality product. Immaturity in quality control or assurance automatically indicates immature quality management, which is responsible for:
- Corporate compliance with regulatory requirements
- Enforcement of regulatory and internal requirements
- Directing operational decision-making and a corporate culture of quality
Aside from signs of immaturity in quality control or assurance, how can you identify immature quality management?
- High rates of SCAR/SCAPA and for-cause audits and a low rate of supplier disqualification, indicating ongoing use of poor suppliers and introducing risk into the quality of materials components received and placing more strain on quality control.
- High variable rates of deviation, OOS, or complaints without coordinated corrective actions to improve enable substandard processes (both manufacturing and supportive)
- Slow or absent reaction to quality issues that warrant reporting and market action
If any of these warning signs sound familiar, don’t panic. Take steps to identify where the maturity problem lies. We have resources to help. You can download this guide to the 6 Digital Maturity Stages.
About the author
Daniel Burns is a Director of Product Management. Dan brings a wide breadth of industry experience coupled with practical knowledge as an end user of TrackWise and TrackWise Digital. He is very knowledgeable of the current FDA, EMEA and Health Canada regulations regarding manufacturing operations, packaging operations, quality control, R&D, warehouse management and distribution practices.