The Quality Management Triad: a Model for Performance Sustainability

Establishing a sustainable Quality Management System that helps a company to become an anticipating, rather than a reactive organization requires intentional effort to bring three essential element together. I call these elements the Quality Management Triad.

The first part is Quality Governance, this is the body that provides:

• Vision—the aspirational view of the future, and how Quality Management is integral to the business strategy for operational performance and continuous product availability to patients;

• Leadership—the top business unit and functional heads who motivate, align, plan, and engage the organization toward its quality goals;

• Standards—endorse the policies and norms, which establish the quality requirements—the interpretation of laws and regulations to your operation—the “what” is required;

• Oversight—the communication channels and forums that give Leadership visibility to product quality and compliance risks and trends—in order to make effective data-driven decisions—and provide Leadership the means to exercise management responsibility.

The second part is the Pharmaceutical Quality System (which is the ICH Q10 term for the Quality Management System). The Pharmaceutical Quality System—or PQS:

•  Management System—the totality of policies, standards, processes that directs and controls activities with regard to quality;

• Processes—to ensure consistency and intentional ways of working when applying the standards to your operation—and to control variables, including the human variable;    

• State of Control—quality is about controlling variation, and the Pharmaceutical Quality System provide the capability of self-detecting and self-correcting problems and give us a clear picture of our current state of control.

• Continuous Improvement—knowing the top regulatory compliance risks at any give time and having project teams directed toward resolving them with verifiably effective solutions.

The third part is Quality System Ownership, which is the specific application of the concept of Business Process Ownership that sets expectations and accountability for managing the constituent parts of the Pharmaceutical Quality System:  Ownership responsibility includes:

• Execution—they manage the daily operation of the quality processes described in procedures and ensure procedures are effective;

• Maintenance—they ensure that the quality process remains current with regulatory requirements and industry practices; and remain applicable to your changing business;

• Performance—they measure how well the process is working and identify problems with the process, and problems that the process detects—and always seeking ways to meet the requirements in the most efficient way.

• Escalation—they identify unacceptable conditions or events that puts the patient and the business at risk—and take the immediate actions necessary to mitigate the risk, and make recommendations for permanently solving the problem.

At the center is the Quality function whose responsibility it is to engineer the processes for these three parts, and to ensure that they work—and work together effectively.

To be clear—quality is everyone’s responsibility. Much like Safety is everyone’s responsibility, it is the Quality function’s responsibility to establish the ways and means for the Quality Management Triad; and ensure effectiveness.

Why is The Quality Management Triad important?

The pharmaceutical industry is a dynamic business environment.  Acquisitions, operational realignment, portfolio changes, manufacturing relocation, facility re-purposing, and organization restructuring and integration are among the strategies to increase stockholder value. These continual changes impact the Quality Management System, and like any other aspect of the operation, it must be managed to remain effective and relevant.

Take this hypothetical example: 

A single-ingredient, solid-oral tablet manufacturer that constructed a dedicated facility for their new product.

Later, high-potency, multi-ingredient tablets were introduced into this facility as line extensions. The facility was then expanded to manufacture oral liquids and eventually retrofitted to produce oral suspension products.

Plans were being made to introduce parenteral drugs into the facility when the decision was made to enter into an agreement with a contract manufacturing operation—a CMO—for that technology, which was the firm’s first venture into a third-party partnership.

All the while, volumes were increasing, markets became global and the company turned to a twenty-four seven operation to keep up with demand. The increased profitability was directed toward the development of promising new drugs, while operating expenses were reduced and tightly controlled to fund new initiatives.

While this was great news for investors and employees, an unintended consequence was quietly undermining the business. The Pharmaceutical Management System had not evolved with the business, and was no longer capable of reliably detecting and managing product quality and compliance risks.

“Loss of management control” was the underlying theme of the series of FDA483s and the eventual warning letter when the site was fraught with recurring manufacturing deviations, missed target dates, and ineffective solutions promised to the Agency.

Although this is a hypothetical case, many people identify with some parts of this story when I share it.

Unfortunately, the Quality Management System is often viewed as a resilient tome of instructional content with little susceptibility to changes in the business environment. Nothing could be farther from reality.

Quality professionals across the industry who have looked back at their past quality problems and regulatory enforcement action, say—ironically—that their Quality Management System was a victim of their success.

Whatever the environment, the Quality Management System must be managed to ensure that it is Fit-for-Purpose and that it continually serves and protects the business.

The Quality Management Triad is a key element of a business strategy to sustain performance and ensure a continuous supply of quality product to patients.

The QA Pharm

Decisions and Indecision—The Organizational Vortex

The cover of Fortune magazine popped off the newsstand shelf last week: What Happened at Pfizer: The Inside Story of Revenge, Betrayal, and Power at the Top of the World’s Largest Drug Company.” (August 15, 2011)

Amidst the story that recounted epic boardroom intrigue, one section described the impact that these political shenanigans had on day-to-day decision-making.

“A second anonymous letter, claiming to be from ‘responsible, long and loyal Legal Division employees,’ arrived on the very day of the board meeting. It complained of ‘micromanagement,’ ‘constant’ internal reorganization, and a ‘chaotic’ decision-making process. ‘A decision is made, then reconsidered and changed. Decisions, even minor…are picked apart and often directed to be undone. Then re-studied. Then the decision-making group expands. Paranoia results. Autonomy is sapped.”

When it comes to fuzzy authority and recycled decisions, Pfizer is not alone. Wherever it occurs, at whatever level, the organization is seriously impacted. It matters how decisions are made. Nothing is more revealing about the leadership and the future of an organization than how decisions are made.

One of the most fundamental responsibilities of top management is to align the organization—to get all the oars of the scullers in the water pulling in the same direction. When company leaders compete for the megaphone it becomes, “Stroke, no don’t stroke. Pull left; I mean right—now, anyway.” The course is convoluted, not straight; energy is wasted, not conserved.

When there is leadership dysfunction, there is organization dysfunction and ultimately the patient suffers. Yes—the patient.

Whether it is getting the organization aligned to resolve its regulatory compliance problems, or on time order fulfillment, it is clear lines of authority and crisp decisions that lead us across the finish line.

So, if you feel sometimes you are in an organizational vortex of ineffective decision-making, my recommendations are these:

1.    When you accept an assignment, be clear about who are the reviewers and approvers. A good Responsible, Accountable, Consulted, Informed (RACI) model applies here.

2.    Establish a charter with a clear scope, lines of communication and decision-making authority. Have your oversight committee approve.

3.    Before you are asked to present to your oversight committee, be sure to clarify whether your authority extends beyond recommendations to decisions. If you are the decision maker, walk the committee through your logic.

4.    Clarify what decision was made. After the presentation to your oversight committee, sum up the decisions. Don’t leave until every decision is crystal clear.

5.    If you were charted with decision-making authority, but your oversight committee takes it out of your hands in a meeting, ask for an explanation. Otherwise, you have no basis of moving forward.

6.    Capture minutes of decisions. Whenever you sense that you are having a “Groundhog Day” meeting, remind the participants that the issue had been discussed and decision had been made as recorded in the minutes.

7.    If anyone on the oversight committee starts to lobby outside of the committee to change the decision, stop it dead in its tracks. Indicate to that person that the decision was made.

8.    When you detect dissention among those of equal authority and it impacts your ability to make progress, meet with them collectively with the stated objective to achieve unified direction.

9.    Document a decision timeline. Nothing points to the effect of poor decision-making than a timeline of direction, redirection, and reverse direction. You may need it when you are asked why your project is behind schedule.

10. Protect your team from the effects of poor leadership decision-making. Make forward progress where you can; assume you make the decision. Resist all temptation to promulgate the organizational vortex.

Don’t be the victim of a dysfunctional environment. You may not be able to take complete control, but you can take steps to minimize its effects.

The QA Pharm

The Top Ten Responsibilities of the Pharmaceutical Quality Unit

The pharmaceutical Quality Unit has been the target of many FDA Warning Letters for not establishing an effective system to prevent product quality and CGMP compliance problems. 

We have seen instances where the ultimate “no confidence” vote is cast when third-party experts are either recommended by FDA, or court ordered to take over their duties. (See The QA Pharm 9/25/10.)

Therefore, it’s very important to have a clear understanding of the regulatory responsibilities of the Quality Unit and to ensure that those responsibilities are effectively executed.

Remember—the Quality Unit is the only job description that appears in the Code of Federal Regulations!

Here’s my compiled list from FDA regulations and guidance documents that defines the job of the Quality Unit.

(It’s like being given the answers in the back of the book—and not just the odd-numbered problems.)

1.    To establish the quality system

a.  Establish the quality management system to describe how the firm complies
CGMPs and operates to maintain a state of control

b.  Keep current with good industry practices, and applicable to the mission of your operation.

2.    To audit compliance to the quality system

a.  Audit for compliance to policies and procedures: on paper vs. practice

b.  Report on the performance of the quality system, including trends, that help
decision making for targeted actions

3.    To establish procedures and specifications

a.  Ensure that procedures and specifications are appropriate and followed

b.  Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.)

4.    To establish manufacturing controls

a.  Ensure that appropriate manufacturing in-process controls are implemented

b.  Ensure in-process controls are performed during manufacturing operations and results are satisfactory

5.    To perform laboratory tests or examinations

a.   Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications

b.  Approve or reject drug products manufactured, processed, packed, or held under  contract by another company, i.e., final product release is not delegated to a contractor

c.  Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions

6.    To review and approve or reject all things CGMP

a.  Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents

b.  Review and approve/reject reprocessing and rework procedures

c.  Review and approve/reject production batch records and make the final decision to release a product lot into commerce.

7.    To ensure investigation of nonconformance

a.  Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes

b.  Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected

8.    To keep management informed

a.  Report on product, process and system risks—and keep management informed

b.  Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed

c.  Keep management informed—get it?

9.    To describe responsibilities in writing

a.  Have a complete and compliant procedure that describes responsibilities

b. Follow the procedure

10. To remain independent

a.  Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities

b.  Be independent reviewer and approver with respect to manufacturing and process/ product development units

How does your Quality Unit compare?

Please contact me to discuss how we can work with your senior staff and quality leadership to ensure your Quality Unit has robust processes to fulfill its regulatory responsibility, as well as help you to become an anticipating organization--rather than reactive.

The QA Pharm

References

• Federal Register Vol. 43, No 190 – Friday, September 29, 1978, “Preamble to the Drug CGMPs”
• The Code of Federal Regulations Part 210 and 211
• Guidance for Industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (September 2006)
• ICH Q10 Pharmaceutical Quality System (June 2008)

Company Culture and CGMP Compliance

I’ve come to the conclusion that compliance with the FDA Current Good Manufacturing Practices (CGMP) is just as much about company culture as it is about anything else. A corollary to this is that resolution of regulatory compliance problems is just as much about organization transformation than anything else.

I have divided companies with significant regulatory issues into two categories: those who seriously strive to intellectually make the connection between the purpose and intent of the regulations and weave it into their business values; and those—well, those who see the FDA regulations as bureaucracy that encumbers its business with onerous rules.

The former eventually arrives to a point of mental assent that CGMPs are a business enabler, since they support the mutual goal of safe and effective drugs that meet important public needs. The latter is frustrated that CGMPs seem to get in the way with its legalistic—almost forensic—investigation and documentation when things do not go as expected.

The former eventually sees company policies and procedures as the declared intent of the company to control the human variable by doing work the best possible way to achieve a predictable outcome. The latter sees policies and procedures as restrictive to their ability to ad lib when situations call for flexible ways of working when faced with the unexpected.

The former sees the quality management system as the means to assure product down to the unit dose level when sampling and testing could never be of sufficient size to provide that level of assurance. The latter considers it a success when all the final product test results are met—or rationalized—and that there are no bodies lying in the street.

The former sees CGMPs as a supporting consistent, reliable manufacturing and continuous product supply to its patients. The latter scoffs at CGMPs saying, “Don’t you understand? We have medically necessary products. We have to find a way to release this lot.”

Culture starts at the top. The behavior of company senior leadership sets the tone for whether the culture embraces or is antagonistic toward the U.S. Food and Drug Cosmetic Act and the Current Good Manufacturing Practices—the price of admission into this business.

The company that applies these regulations in the spirit and intent, as well as efficiently and effectively as possible—will have the most economical control of quality, and will have a competitive advantage.

So in the end, how will you know when the culture has favorably changed? It will be when everyone—top to bottom—becomes self-correcting. When one sees another doing something out of compliance, he/she says: “We don’t do it that way here.”

The QA Pharm

The Quality Assurance Practitioner: A Metaphorical Model

There can be no higher calling than to be a quality assurance professional in the pharmaceutical industry.

And, I do mean a calling. It’s not just a job. It is an honorable profession where art and science are skillfully applied to improve and save lives.

That sounds a lot like a medical doctor, doesn’t it?

Actually, the medical practitioner provides an excellent model to think about what we do, and how to continually strive to improve our service.

Metaphorically speaking, as quality assurance practitioners we:

OBSERVE to detect the earliest symptom that could indicate a quality well-being problem.

APPLY QUALITY SCIENCE to describe and characterize the presenting problem.

DIAGNOSE the underlying cause and systems involved using problem-solving and decision-making skills.

COMMUNICATE to all affected to ensure that there is understanding of the nature, extent and consequences of the condition if left untreated.

CONSULT the literature, colleagues and specialists to ensure that current knowledge and objectivity are applied to the problem.

PRESCRIBE a remediation plan using current science, technology and Management 101 with an emphasis on prevention.

OVERSEE the implementation of the remediation plan to ensure the plan is executed and well managed.

FOLLOW-UP at appropriate intervals to review progress and to evaluate the effectiveness of the remediation plan.

RESEARCH to continually advance the field and apply new knowledge to the practice of the art and science.

DEVELOP skills that continuously enhance personal effectiveness in applying the art and science.

What is it that you like about your favorite physician? Is it your access to him when you really need help? Is it her pleasant and professional staff? Perhaps you feel he is a good listener. I also imagine that getting results is high on the list.

Did you ever stop going to a doctor for a particular reason?

Was it because he multi-tasked while you were trying to talk to her? Did he always seem to be in a rush for her next appointment? Unsympathetic? Did he talk down to you? Perhaps you felt unsettled whether the visit was really productive.

Likewise, pharmaceutical quality assurance professionals interact daily with people and problems. Metaphorical thinking helps to shine a light on where we may need to improve--both what we do, and how we interact with others.

Consider it our own version of competent "bedside manner."

The QA Pharm