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
