The Dynamic Pharmaceutical Business Environment
The pharmaceutical quality management system (QMS) is comprised of policies, standards, procedures, and other approved instructions that declare how a firm intends to apply company requirements, laws, and regulations to their operations. The QMS defines processes, controls the human variable, maintains a state of control, and contributes toward a predictable product quality outcome.
However, the QMS lives in a dynamic business environment characterized by acquisitions, portfolio changes, operational realignment, manufacturing relocation, facility repurposing, restructuring, and workforce right-sizing. The QMS also lives in a dynamic regulatory environment of the registration and compliance requirements of global markets as well as inspections.
Surprisingly, the QMS is often viewed as a static tome of compliance content with only peripheral relevance to changes in the dynamic environment of the business. Nothing could be farther from reality.
The QMS must continually be reevaluated to ensure that its purpose is served. For example, the procedures of a single-active ingredient solid oral dosage form will not be completely applicable to a multi-active ingredient product. The procedures controlling a solid oral dosage form facility will not suit a parenteral facility. Facilities retrofitted to accommodate additional or different production lines undoubtedly require procedure changes. Role changes, job combinations, right-sizing, and voluntary early retirement programs have a great effect on subject-matter expertise, institutional knowledge, and the overall QMS effectiveness.
Regardless of the changes to the business environment, the requirement to operate in a state of control remains a constant expectation of all the stakeholders: management, regulators, investors, healthcare professionals, and not the least—patients.
Energy must be put into the QMS in order to maintain it. The focal point of that energy must emanate from someone who has the responsibility and authority to ensure that each constituent part of the QMS remains compliant and relevant to the operation. The head of quality has specific functional responsibility for the QMS, and company officials have ultimate legal responsibility for compliance with the Food, Drug and Cosmetic Act. However, knowledgeable individuals at the operational management level are needed to take command of each constituent part of the QMS.
These individuals will be called the quality system owners. Quality system owners are managers at the operational level who have the front-line responsibility for one or more quality systems. They ensure that their respective parts of the quality system are relevant, compliant, and efficiently integrated with the other parts of the QMS.
Yet, all too often firms cannot point directly to their system owners, and their responsibilities are typically too general to drive the definitive behavior necessary to achieve sustainable compliance and a continually applicable QMS.
Firms need to be able to provide crisp and unequivocal answers to the questions: “Who owns this quality system? What are your expectations of the quality system owner?”
The importance of management to the pharmaceutical QMS has been described elsewhere (1). The focus here is on the crucial responsibilities of quality system owners and the need for senior management to set performance expectations of quality system owners and provide support to succeed in a dynamic business environment.
Quality System Ownership Responsibilities
In the structure of the overall QMS, there are constituent quality systems. For example, within the QMS there is a family of engineering systems such as preventive maintenance, calibration, and critical utilities. There is a family of supply chain systems such as supplier quality management, purchasing control, and quality technical agreements. Within the family of contamination control systems, there are systems such as gowning and hygiene, disinfection, cleaning, and environmental monitoring. Quality assurance includes a family of systems such as change control, periodic product review, and quality management review.
These are just a few structural examples of quality systems within the overall QMS. For the purposes here, more important than how these various quality system elements are organized is the need for each quality system to have a named owner and that ownership is defined by a set of responsibilities and performance expectations.
Quality system ownership responsibilities include the following.
Quality system design relates to the structure and content of the approved policies, standards, procedures, and work instructions that govern how work is performed. Responsibilities include:
- Ensuring the system is maintained in compliance with corporate standards
- Following industry and regulatory trends to ensure the system remains compliant
- Ensuring the system remains applicable to the operation
- Ensuring the system is integrated within and between families of systems
- Communicating with system users to ensure design is efficient
- Collaborating with system owners in the network to share best practices.
Quality system implementation relates to putting the system into practice by the writing, approving, and training on procedures. Responsibilities include:
- Establishing and maintaining clearly written procedures
- Ensuring system users are qualified by establishing requirements and providing training content
- Identifying and resolving implementation issues within and between area management.
Quality system performance relates to the results achieved by operating the system in terms of regulatory compliance, product quality, and business results. Responsibilities include:
- Monitoring performance metrics, drawing conclusions, and making recommendations for the quality management review (QMR) forum
- Identifying compliance and product quality issues and championing solutions
- Identifying risks and escalating them to the department head and relevant governance body
- Identifying needs for performance improvement and interacting with users and training departments
- Exhibiting intolerance for repeated event or systemic failures
- Making effective use of resources and continually improving system efficiency.
Subject Matter Expertise
Quality system subject matter expertise (SME) relates to possessing the knowledge, experience, and skills to be an authority on the system. Responsibilities include:
- Maintaining current industry knowledge regarding the system
- Representing the system on network and site project teams
- Defending the system to regulatory inspectors and effectively addressing questions
- Ensuring observations are systemically addressed and verified and monitoring their performance.
Quality system business planning relates to representing the system for the process that establishes site and personal objectives. Responsibilities include:
- Making data-driven business cases for capital and expense budgets and headcount changes
- Being able to associate and claim cost savings for system improvement initiatives
- Making data-driven cases for input to the site and personal objectives planning process
- Providing feedback on accomplishments versus objectives.
Setting Different Expectations
Career descriptions are usually written in general terms. For quality system owners, there may be one line in their job description such as, “Responsible for managing assigned quality system.” Some individuals may possess the perspective, skills, and initiative to exhibit ownership behaviors for their assigned quality system. More often, unfortunately, individuals have limited horizons and fail to see the opportunities in which they can have significant impact. Even more unfortunate is that management may not fully appreciate the need for a different set of expectations.
Particularly in an active regulatory enforcement environment where management is challenged to think and operate differently, it becomes important to ask quality system owners for different behaviors to achieve different results. Using a battlefield analogy, one does not want to pay for the same ground twice. This properly acknowledges that the compliance remedial efforts must be directed toward the quality system design and implementation as well as behavioral aspects of the organization and quality system owners. Management is in the position to redirect its quality system owners, but it has to intentionally request and reward a different set of expectations.
While it is important to identify quality system owners and set new expectations, it is also important to acknowledge that for any given system there may be many users across multiple functional areas, and that each user has an impact on the performance of the system. Take the deviation management system as an example. There are many users of the system across the entire operation, and functional area management must appropriately take responsibility for addressing their own deviations in an effective and timely manner. However, this does not diminish the crucial role of the quality system owner who champions the system and brings focus to an otherwise diffuse and unattended approach to managing the QMS. Thus, setting particular and individual quality system ownership expectations is essential to achieve results.
The usual mechanism in business for setting individual expectations is the performance review process, where the employee and his/her manager periodically discuss progress toward personal objectives. These objectives are designed to enhance the employee’s skills and direct effort toward accomplishing realistic, specific, and measurable results. Using the performance review to redirect behavior leverages a familiar business process to achieve new expectations.
The Quality System Ownership Expectation Checklist (Attachment 1) is a tool to guide the discussion between the quality system owner and his/her manager regarding new requirements for sustaining a relevant quality system in a dynamic business environment.
Both the quality system owner and the manager must realize, however, that these new expectations may not come easily for either person. Having mutual recognition of potential obstacles, respect, and support will help to achieve positive results.
Activity: Identify quality system owners by name for each system or family of systems. Using the Quality System Ownership Expectation Checklist, ask the quality system owner score him/herself and then share the results with his/her manager. Negotiate an agreement on the score and identify realistic, specific, and measurable objectives in each section.
Overcoming Potential Obstacles
Having different expectations and changing behavior is part of organization transformation. Transformation is always met with obstacles. The best way to overcome an obstacle is to identify and describe it upfront and then put into words what needs to change.
Here are some examples of potential obstacles that one might anticipate:
- Obstacle: The quality system owner does not work or negotiate outside of his/her functional area to improve the system, although success is dependent on other functional areas and/or linked systems.
- Undesired behavior: Allow performance to deteriorate until it becomes apparent by other functional area management that something must be done, and then direction will come top-down within that area.
- Desired behavior: Confidently and directly approach area management, make the business case for the need for improvement, and offer to help.
- Obstacle: The quality system owner perceives s/he has no authority and that changes to system requirements are initiated top-down only.
- Undesired behavior: Wait for corporate directives or regulatory inspection observations to provide the impetus for system changes.
- Desired behavior: Become the most knowledgeable person about the system at the site and proactively make the case for changes (additions/ deletions) in the requirements.
- Obstacle: Management must endorse initiatives and decisions; actions and decisions are delegated upwards.
- Undesired behavior: Management enables the lack of taking initiative by creating an environment where s/he must be second-guessed by the quality system owner.
- Desired behavior: More appropriate boundaries of authority are set, and taking initiative is verbally and publicly praised and rewarded.
- Obstacle: Cross-functional collaboration is difficult due to the maze of approvals, communication, and presentations required by management.
- Undesired behavior: Management discourages cross-functional collaboration by quality system owners since they perceive that buy-in must first be obtained from his/her management peers.
- Desired behavior: Cross-functional collaboration is encouraged and celebrated.
These are hypothetical examples, but management and quality system owners—or the site leadership as a whole—will need to identify its unique obstacles to implementing new expectations for quality system owners.
Activity: As a site management team, working with quality system owners, use an appropriate method such as a survey or facilitated discussion to identify the most anticipated obstacles to exercising quality system ownership described here. Describe the current undesired behavior as well as the future desired behavior. Discuss the factors that motivate behavior to the desired state.
The pharmaceutical industry must continually respond to internal and external demands and opportunities. The quality management system must respond to these business changes in order to be relevant, serve its purpose, and maintain a state of control. Responding to changes, as well as maintaining daily vigilance over assigned parts of the quality management system, is the responsibility of the quality system owner. Specific responsibilities must be deliberately established to maintaining a sustainable system. Site management must set performance expectations and work together to overcome obstacles that are counterproductive to new quality system ownership behaviors. Deliberately identifying new behavioral expectations and associated obstacles is part of an organization transformation process that is necessary, not only in an active regulatory enforcement environment, but also part of normal business to maintain the viability of the quality management system.
- J. Snyder, “Management Oversight of the Pharmaceutical Quality System: Obstacles and Opportunities,” Journal of GXP Compliance 17 (2), 2013, available at: http://www.ivtnetwork.com/management-oversight.
- J. Snyder, “Management Responsibility for the Quality System: A Practical Understanding for the CEO in FDA-Regulated Industries,” Journal of cGMP Compliance 3 (3), 55-59, 1999.
Attachment 1: Quality System Ownership Expectations Checklist
|Ensures the system is maintained in compliance with corporate standards|
|Follows industry and regulatory trends to ensure system remains compliant|
|Ensures the system is applicable to the operation|
|Ensures the system is integrated within and between families of systems|
|Communicates with the system users to ensure design is efficient|
|Collaborates with the system owners in the network to share best practices|
|Establishes and maintains clearly written procedures|
|Ensures system users are qualified by establishing requirements and providing training content|
|Identifies implementation issues and resolves them within and between area management|
|Monitors performance metrics, draws conclusions, and makes recommendations for QMR forum|
|Identifies compliance and product quality issues and champions permanent solutions|
|Identifies risks and escalates to the department head and governance body|
|Identifies needs for performance improvement and interacts with users and training departments|
|Exhibits intolerance for repeated event or systemic failures|
|Makes effective use of resources and continually improves system efficiency|
|Subject Matter Expert|
|Maintains current industry knowledge regarding the system|
|Represents system on network and site project teams|
|Defends the system to regulatory inspectors and effectively addresses questions|
|Ensures observations are systemically addressed and verified and their performance monitored|
|Makes data-driven business case for capital and expense budgets and headcount changes|
|Able to associate and claim cost savings for system improvement initiatives|
|Makes data-driven case for input to the site and personal objectives planning process|
|Provides feed back on accomplishments versus objectives|
- Use as a discussion tool between the manager and the quality system owner to provide positive feedback as well as to identify specific areas for improvement.
- Enter score according to the following definitions specific to System Ownership Behaviors:
- 3 Exceeds expectations
- 2 Meets expectations
- 1 Need improvement
- 0 Not yet exhibited
- Build this checklist into the quality system owner performance review process and periodically review progress toward expectations.