Sunday, February 23, 2014

Quality System Design Attributes: Criteria for an Operational and Sustainable Pharma Quality System

There are many instances when a pharmaceutical quality management system (QMS) must be improved in part or as a whole. In some cases improvements are made in response to regulatory inspection observations. In other cases improvements are made when new company standards are deployed in order to remain current with changing regulatory requirements and current industry practices. Still other improvements are made to support the changing mission and product portfolio of the business.

Whatever the driver may be, a mindful approach must be taken when designing the quality system to ensure that the organization is capable of operating and sustaining the system. Unfortunately, improvements are often viewed as an SOP-writing exercise without considering the factors that help to ensure that implementation is successful.

The following is a discussion of ten Quality System Design Attributes (QSDA) that must be considered as part of the quality system improvement process to ensure that the organization is ready and capable of operating and sustaining the system. These attributes can be considered essential design criteria, because these attributes are the most common root causes for the failure of the quality management system and consequent regulatory enforcement actions.

These attributes are worthy of serious consideration by those who are engaged in quality system development, as well as change management coaches that support adoption of new systems.

1. Standards and Site Procedures
These are part of a document hierarchy that collectively comprise the Quality Management System (QMS) and declares how a company intends to operate in compliance with laws, regulations and company requirements. While standards establish the requirements, procedures provide the detail for how they are applied to a specific operation. This architecture provides the structure for the library of interlinking requirements and instructions. Without standards and procedures, there is no control over the way work is performed and how decisions are made.

2. Process
An orderly process flow facilitates a common understanding of how work is performed. Process flow diagrams commonly appear in procedures, and process mapping is often the first order of business when designing a new system, or improving an established one. Process flows also support value stream analysis and employee training by showing the big picture, key interactions and decision points. Incomplete, inefficient and disjointed processes open the door to informal practices to develop over time due to the lack of a fluid, practical or understandable way of working. Designing the process to be Fit-for-Purpose and useable is essential for compliance.

3. Decision Processes
Most processes have decision points. While some decisions may be very straightforward, others may require critical thinking skills to weigh available information, assess the risks and implications in order to make the best-informed decision. Some decisions require the participation by other stakeholders, or escalation to higher levels of management, especially when events or conditions arise that create an unacceptable risk. Ensuring that decision processes, decision makers and escalation criteria are clearly described in procedures helps to establish appropriate responsibilities, governance and risk management.

4. Role of Quality Assurance
Quality Assurance (QA) has a unique, independent decision-making role codified by the Code of Federal Regulations. It involves review and approval of all cGMP matters, as well as the release of product into interstate commerce. QA also has a role within each quality system that must be procedurally established. This will include QA reviews and approvals, as well as a description of the type of events and conditions where QA must be notified. QA must not be put into a role where there would be a conflict of interest such as expediting production or approving its own work. Establishing the role of QA ensures the independent oversight and support required by our industry.

5. Records and Documentation
Equally important to procedures are the records created when procedures are followed. Examples of records include batch records, forms, logbooks, drawings, recording charts, and printouts. Instructions are given in procedures on how to complete associated records. These records are signed and dated by the one performing the work at the time the work is performed. Some records are considered so important that the work and the entries must be witnessed. It is common to have standards and training on good documentation practices to promote clear and consistent written entry conventions, as well as to prevent the perception of fraud. The design and content requirements, as well as storage and archiving of records are very significant. Complete, accurate, and timely records provide the batch history and facilitate data mining and support investigations.

6. Performance Metrics
Performance metrics are at the core of managing the quality management system. Performance metrics are designed into system procedures and are intended to help the system owner manage the performance of the system, and to detect problems. Metrics also help to identify improvement targets and measure the effectiveness of decisions and actions. The review of quality system performance metrics is the main content of the Quality Management Review (QMR) process. The QMR is at the core of Quality Governance, since it brings together cross-functional management, system owners, and performance metrics for the purpose of ensuring that risk are identified, effective decisions are made, and that the quality management system is continually effective. Performance metrics are essential for becoming an anticipating organization.

7. Infrastructure
Infrastructure is an attribute that encompasses a wide variety of tangibles that support the effectiveness and efficiency of the system. These could include facilities, equipment, software, and co-location of system users. Supporting infrastructure may be mentioned in procedures if they are part of the process (e.g., TrackWise software). Sometimes infrastructure is assumed (e.g., space and computers). Since infrastructure support takes significant lead-time to implement, be sure to allow sufficient time in the implementation plan in order to meet commitment dates.

8. Organization, Skills and Resources
To effectively execute the process and make appropriate decisions requires skilled system users and a supportive organization structure. Changes to each quality system require that the organization structure, skills and resources be evaluated to ensure that the organization is capable and ready to operate the new system.  Each role specified in a procedure must have identifiable personnel that have the education, experience and skills to perform the assigned activities. Implementation of the new system requires role-based training and a learning assessment in advance of start-up to ensure organization readiness. The bigger the change, the more effort will be required to be ready for effective implementation.

9. Dependent Linkages
The QMS is a network of interrelated systems. When designing a quality system, it is important to consider not only the inputs and outputs within a system, but also between systems. Inadequate linkages between systems create “short circuits” and can cause the quality management system to fail. Ensuring effective linkages can be a challenge when undertaking a comprehensive quality system remediation effort, since the state of the relevant linked systems can be a moving target, or the sequence of remediation targets may not be optimized. Nonetheless, the identification and continual assessment of dependent linkages is essential for an integrated and well functioning quality management system.

10. System Ownership
Each quality system must have a defined owner who takes responsibility for the design, procedures, operation, performance, reporting, and improvement of the system. The system owner also ensures that the system continually evolves as regulatory and industry expectations change, and when there are changes to the business portfolio, organization structure and function. Clear system ownership and ownership behavioral expectations are essential to fundamental quality system management. Establishing systems owners sets apart key personnel who can work together within and across sites for internal benchmarking and continuous improvement. These system owners also become a sub-set of company experts where investment of continuous education and development is well placed.

A Word About Working with OpEx Change Management Coaches

Quality system development efforts definitely require the organization to be ready and capable of adopting and adapting to changes required for sustainable implementation. The value of the effort in terms of time and cost can only be realized if the improved quality systems that are the result can be sustained. So this area of the business is definitely worthy of Change Management attention (not to be confused with the Change Control quality system). The challenge is to align and leverage quality system development and change management activities and targets. Here is where the ten Quality System Design Attributes come in.

These ten Quality System Design Attributes represent the areas where the most significant changes will occur and where support may be needed. Teams must identify the anticipated changes for each of these ten attributes. Each change must be clearly described (from what to what?) and expressed as a tangible quality system design deliverable. These changes must be assessed to determine whether the change is incremental or transformational. Change Management coaches can facilitate the conversation and organization preparation to receive and operate the new or improved system, particularly where the most significant changes will occur.

The QA Pharm