Quality Management as a Program

Quality System Management should be viewed and governed as a program

Program management is commonly defined as “a group of projects that contribute to a common, higher order objective.” The projects in a program are related, and the intent of achieving benefits would not be realized if the projects were managed independently.

Program management includes the practices and processes of strategic alignment, benefits management, stakeholder management, governance, and lifecycle management. Program governance creates the control framework for delivering the programs’ change objectives and making benefit delivery visible to the organization’s control.

There are different styles of program management and what I am focusing on here is what is sometimes called “heartbeat”, which aims to achieve evolutionary improvement of existing systems and processes or organizational change. This program type creates value by reconciling contradicting views and demands for change from various organization actors in order to enhance existing systems and practices while sustaining operations.

Heartbeat program management is all about awareness of the contexts of the program and requires knowledge of strategy, competition, trends in the industry, and differences in management practices between the business units of the company. A good heartbeat program manager is highly concerned about their program’s long-term effects and implications for the company’s business.

Magic triangle of a program manager

Programs exist to create value by improving the management of projects and to create benefits through better organization of projects. The fundamental goals of program management are:

  • Efficiency and effectiveness: Aspects of management that a proficient project manager should address and benefit from coordination.
  • Business focus goal: The external alignment of projects with the requirements, goals, drivers and culture of the wider organization. These goals are associated with defining an appropriate direction for the constituent projects within a program as well as for the program as a whole.
GoalDescription
Efficiency and effectiveness goals
Improved co-ordinationAssist in identification and definition of project inter-dependencies and thereby reduce the incidence of work backlogs, rework and delays
Improved dependency managementReduce the amount of re-engineering required due to inadequate management of the interfaces between projects
More effective resource utilizationImprove the effectiveness and efficiency of the allocation of shared resources
Assist in providing justification for specialist resources that deliver an overall improvement to program delivery and/or business operations
More effective knowledge transferProvide a means to identify and improve upon transferable lessons.
Facilitate organizational learning
Greater senior management ‘visibility’Enable senior management to better monitor, direct and control the implementation process
Business focus goals
More coherent communicationImprove communication of overall goals and direction both internally and externally to the program
Target management attention clearly on the realization of benefits that are defined and understood at the outset and achieved through the lifetime of the program and beyond
Assist in keeping personal agendas in check
Improved project definitionEnsure that project definition is more systematic and objective, thereby reducing the prevalence of projects with a high risk of failure or obsolescence
Enable the unbundling of activities in a strategic project-set into specific projects
Enable the bundling of related projects together to create a greater leverage or achieve economies of scale
Better alignment with business drivers, goals and strategyImproves the linkage between the strategic direction of organizations and the management activities required to achieve these strategic objectives
Provide an enabling framework for the realization of strategic change and the ongoing alignment of strategy and projects in response to a changing business environment (via project addition/culling, etc.)

The Attributes of a Good Heartbeat Program Manager are the Attributes to a Good Quality Leader

As quality leaders we are often ambassadors to ensure that the quality program is progressing despite the conflicting requirements of the various stakeholders. We need to actively influence quality-related decisions of all stakeholders, including people holding superior positions. Having a well-developed personal network within the organization is particularly helpful.

It is critical to always be communicating about the quality program in a visionary way, to be seen as passionate ambassadors. Playing this role requires constant attention to differing expectations of the stakeholders and various ways to influence stakeholders for the benefit of the quality system. To always be striving to build quality, to advance quality.

As advocates for Quality, it is a core competency to be able to stand up and defend, or argue for, the quality program and team members. This ability to challenge others, including their superiors, in a productive way is a critical ability.

A key focus of the quality program should be on engagement with a conscious and sustained drive to secure buy-in from key stakeholders (including senior management) and win over the hearts and minds of those responsible for execution to make changes feel less painful and inflicted. As quality leaders our aim should always be to engender a climate of comprehension, inclusion and trust, and to draw upon expertise globally to create fit for purpose processes and systems

Effective quality leaders need to be “heavyweight” organizational players.

Core Competencies of the Heartbeat Manager

  • Contextual awareness
  • Scenario planning
  • Political skills
  • Courage
  • Networking

A note on program life

Many standard approaches perceive programs to have a finite life. This is constraining given that the strategies themselves, especially as applied to quality, have long lifetimes. I believe that program management has as much to learn from quality management,  and there is a lot of value in seeing an indefinite time horizon as beneficial.

Quality management is an evolutionary approach, and utilizing program management methodologies within it should be taken in the same light.

What does a quality reviewer do?

ICH Q10 states , “Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system.” One of the central roles of the Quality reviewer/approver is to provide leadership, driving each event/record/etc, and the system as a whole, to continually improve. Quality does this in three ways:

  1. Ensuring the process is followed
  2. Validating the decisions made
  3. Creating a good history

Ensuring the process is followed

The quality review provides a coaching/mentoring opportunity to build and/or enhance capabilities and behaviors and recognize and reinforce desired behaviors.

Questions to Ask

1.       What is the process? What process and steps apply?

2.       What is expected? Look for: Standard work, expected state, variation to the expected state

3.       What is working well? Look for: process being followed, ideas being generated, lessons shared

4.       What is not being followed? Look for: variation to procedural requirements, poor technical writing

Validating the decisions made

Quality is ultimately responsible for the decisions made. For each decision we do the following:

  1. Identify alternatives. Once you have a clear understanding of the record from ensuring the process was followed, it’s time to identify the various options for each decision.
  2. Weigh the evidence. In this step, you’ll need to “evaluate for feasibility, acceptability and desirability” to know which alternative is best. It may be helpful to seek out a trusted second opinion to gain a new perspective on the issue at hand.
  3. Choose among alternatives. When it’s time to make your decision, be sure that you understand the risks involved with your chosen route. You may also choose a combination of alternatives now that you fully grasp all relevant information and potential risks.
  4. Take action. Ensure the quality system/process reflects the action.
  5. Review your decision. An often-overlooked but important step in the decision making process is evaluating your decision for effectiveness. Ask yourself what you did well and what can be improved next time.

Creating a good history

If it Isn’t Written Down, then it Didn’t Happen” is a guiding principle of the quality profession.

There are four major types of writing in quality: instructional, informational, persuasive and transactional. A well written event is both instructional and transactional.

Our quality systems record what happened, finalize recommendations and action plans, and to act as an archive. A well written report allows the reader to easily grasp the content and, if applicable, make informed decision. Report writing is a cornerstone of an Event/CAPA system (from incident identification to root cause through CAPA completion and effectiveness review), validation, risk management and so much more.

In short, reports are our stories, they form the narrative. And how we tell that narrative determines how we think of an issue, and how we will continue to think of it in the future.

Mylan Warning Letter

Mylan’s West Virginia plant received a Warning Letter this month and US FDA Commission Scott Gottlieb tweeted on it, and Mylan recently issued a press release.

I’ve made a few posts on their 483:

Mylan’s issues really need to be viewed as a lens of current regulatory body thinking and not as an issue of a company behind the times. In short, this could be you and if your company is not pouring through these and evaluating your own systems you should be.

The Warning Letter has a few trends we see in this sort of document:

  1. Requiring an independent review. If your system is broke than the agency doesn’t trust you to say its okay. Get an independent consultant.
  2. Lack of quality unit authority. One of the best things my site head of quality ever said (and if he is reading this, take this as a serious compliment) was to a group of high school interns when he said the quality unit is the only part of the Pharma manufacturing organization with duties required by law. That we have a legal duty to our companies and to the patients.
  3. Go to the ICH guidance documents
  4. This is happening at more than one site. Clean it up corporate wide.

The last one is worth further thought:

These repeated failures at multiple sites demonstrate that Mylan’s management oversight and control over the manufacture of drugs is inadequate.Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products you manufacture, consistently conform to FDA requirements.

It is a critical part of your inspection program to be evaluating issues at each and every one of your sites for all your sites. The CAPA program needs to have the ability to assess CAPAs for similar root cause at all sites, that’s part of the preventive, and without it you are truly not addressing all the potential risks in your organization.

In past decades Mylan was a golden-child of cGMPs, and a lot of thought has gone into why the massive backslide. Cases like this, and Toyota, really reaffirm how a quality culture is something that must be constantly maintained and grown, and how easy it is to go backwards.