A Poster: Selling Your Proposal

Have you ever wondered why the Sales and Marketing Departments walk out of the boardroom with a bag full of money after they made their pitch, but board members only see you and your Quality Unit presentation as the bearer of bad news?

I have seen it too many times to count. The Quality Unit has a legitimate business-impacting proposal  that is worthy of serious consideration, but the presentation of their proposal takes the listener into an unfamiliar world and is unable to make the business connection.

Perhaps effective communication is a core competency of the Sales and Marketing Departments, while the Quality Unit relies on the tired arguments of regulatory requirements and the threat of an FDA 483.

Don't get me wrong. Compliance with regulatory requirements is the price of admission into the pharma industry. But that is no reason for putting very little effort into selling  your proposal in a way that is compelling--or swamping the boardroom with a 20-page PowerPoint of endless detail and data.

One underlying principle for making a compelling case to management is to make it simple and direct. In fact, the higher the level of management the simpler and more direct it needs to be.


Here are a few points to consider when developing a proposal:

1.    The general purpose of any proposal is to persuade the readers to do something.

2.    Make the reader understands that the solution is practical and appropriate.

3.    Build the case by demonstration of logic and reason in the approach taken in the solution.

4.    Facts must lead logically and inevitably to the conclusion and/or the solution presented.

5.    Evidence should be given in a descending order of importance, beginning with the most important evidence and ending with the least important.

6.    Any questions the reader might pose should be anticipated and answered in a way that reflects the position of your proposal.

7.    Consider all sides of the argument—providing other alternative solutions to the problem, but showing how the one chosen is superior to the others included.

8.    Answer questions about what you are proposing, how you plan to do it, when you plan to do it, and how much it will cost.

9.    Ascertain the level of knowledge that your audience possesses and take the positions of all your readers into account.

10. Use the materials and language to appeal to the technical level of the reader.  Be concise and direct.

Now--How to structure your proposal.

Consider structuring your proposal using the SPIN method. This method is based on SPIN Selling by Neil Rackham. The SPIN acronym stands for Situation, Problem, Implication and Need. 

Here is a simple poster that illustrates using the SPIN approach. Use it not only to structure your next proposal, but give this your the next staffer that brings you a problem without thinking through how best to address it.

Remember, your added value is your insight to resolving the problem, not just escalating problems to the next level. The same goes for those who report to you.

Hope this helps!

The QA Pharm
John E. Snyder

A Poster: Three Stages of Quality Management System Implementation and Oversight

A Poster: Three Stages of Quality Management System Implementation and Oversight

If I could summarize in one page the most important lessons I have learned in pharmaceutical Quality Assurance over the last 40 years, this is it.

This acknowledges that putting words in a procedure does not mean they will be put into action or be effective.

The responsibility of Quality Assurance is to ensure that an effective Quality Management System (QMS) is put in place procedurally, is in use behaviorally, and is in control measurably.

The responsibility of Management is to enable each element of the QMS by means of an identified owner; to provide oversight through performance metrics; and to promote the QMS as a normal and valued part of the business---not to make the FDA happy or pass an inspection.

As I reflect on my pharmaceutical career and the many clients I have served over the years, the best results and most rewarding experiences were with those who embraced this concept.

My hope is for all my followers to use this simple graphic as a way to communicate a QMS implementation strategy.

I would be pleased to support your effort with details behind each of these points.

If you would like a high resolution image, please write to me at my personal email address: snyderjohn@mac.com. You have my permission  to use freely.

The QA Pharm

Management Responsibility for GMP Oversight and Control: A Review of Requirements

Supreme Court Cases

Historically, the FDA has cited the Supreme Court decisions of  United States v. Dotterweich (1943) and United States v. Park (1975) as FDCA legal cases that establish that the manager of a corporation can be prosecuted under the Federal FDCA, even if there is no affirmation of wrong-doing of the corporation manager individually.

In the Dotterweich case, the jury found Dotterweich, the president and general manager of a drug repackaging company, guilty on two counts for shipping misbranded drugs in interstate commerce, and a third for shipping an adulterated drug. One dissenting judge of the Circuit Court of Appeals reversed the decision on the grounds that only the corporation was the “person” subject to prosecution, thus protecting the president personally. But the Supreme Court reversed the decision thus holding Dotterweich individually responsible, not just the manufacturer. Justice Frankfurter delivered the opinion of the Court, “... under § 301 a corporation may commit an offense and all persons who aid and abet its commission are equally guilty….”

In the Park case, the chief executive officer was found guilty on all counts involving food held in a building accessible to rodents and being exposed to contamination by rodents, resulting in the adulteration of the food within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA). Park’s defense was that he had an organizational structure responsible for certain functions to handle such matters. However, evidence from inspections of multiple locations indicated the same problems and inadequate system for which he had overall responsibility. Chief Justice Burger delivered the opinion of the Court, “... by reason of his position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that he failed to do so... the imposition of this duty, and the scope of the duty, provide the measure of culpability...”

FDASIA

More recently, Public Law 112-144 (July 9, 2012) called the Food and Drug Administration Safety and Innovation Act (FDASIA) added to the definition of CGMP in the Food and Drug Cosmetic Act (Section 501, 21 U.S.C. 351) to explicitly include management oversight of manufacturing to ensure quality. Section 711 of FDASIA states:

• For the purpose of paragraph (a)(2)(B), the term “current good manufacturing practice” includes the implementation of oversight and controls over the manufacturing of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.

The addition of oversight and controls to the definition of CGMP has strengthened the FDA position with specific language for management’s responsibility for oversight and control as a requirement in the Act. The question remains how to practically and operationally to perform this responsibility. The following model describes essential elements of a CGMP Management System for oversight and control.

Management System 

The implication of the impact of CGMP noncompliance on the business is not theoretical. There are ample examples in the pharmaceutical industry where ineffective implementation of CGMP systems resulted in the loss of control that materially affected product quality, which, in turn, affected inventory and patient supply. Establishing a Pharmaceutical Quality System (PQS) that effectively implements the CGMPs is the means for maintaining a state of control—the fundamental intent of these regulations.

Management does not assume positions of responsibility with the intent of neglecting CGMP compliance. However, management may not enter the top position fully equipped to assume responsibility for CGMPs in a practical way. Management may delegate all CGMP matters to the Quality Department and take a hands-off approach and rely on this function to bring matters to its attention at their discretion. Such passivity leads to hearing only the bad news when it is far too late to contain and resolve the problem in the most cost-effective way with least risk to public safety.

Likewise, some Quality Departments may not be adequately equipped to bridge the space between top management and daily operations with effective structures and processes that enable management to exercise its responsibility for CGMP oversight. Too often the default position is to rely upon the outcome of regulatory inspections. But as one might expect, a good outcome can give a false sense of security, and a poor outcome can be viewed as the exhaustive list of problems. As in any area of the business where risks must be managed, there is no better approach than having an intentional management system in place that provides actionable data to know internally where your daily operation stands at any given moment.

Assess, Improve, and Implement--and Perform

For nearly 20 years, John Snyder and Company has served the pharma industry to assess, improve, and implement the Pharmaceutical Quality System (PQS). Our Management Triad Model will help you to assess and develop the crucial structures, systems, and processes for Management Oversight and Control for monitoring your state-of-control and to become an anticipating organization.

Please contact me at john@john-snyder.com. I want to partner with you.

The QA Pharm

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

Part 5: Five Obstacles to Management Oversight of the Quality System

This is the fifth and final part in this series that addresses underlying obstacles to management oversight of the pharma quality system as evidenced by the the continuing serious compliance and product quality problems in our industry.

Part 1 dealt with the management perception that cGMPs are not relevant to the business, and it laid out the defense that cGMPs enable a predictable quality outcome that serves the business and its patients very well. 

In Part 2, the quality function was indicated to be in the best position to make the defense of the relevance, but all too often it has problems of its own and should be the focus of serious organization development. 

In Part 3, it was recognized that although management may be responsible for the quality system, they may not know how to exercise that responsibility. It is the responsibility of the quality unit to provide a forum where management can make data-driven decisions and monitor quality system performance. 

   In Part 4, the case was made for the importance of a company to have channels throughout the corporate structure to be able escalate product quality and compliance risks, as well as disseminate corporate directives, since there are many examples in our industry of problems at one site affecting all the others.

   When it comes to taking site-wide and company-wide action, there are tools at hand to establish priorities and drive behaviors. The same tools can apply to improvements to and problems identified by the quality management system.

   Obstacle 5: Quality Planning and Performance Management Systems are not Leveraged for Large-scale cGMP Performance Improvement

Warning letter observations are commonly phrased as a failure of the QCU to establish an adequate system for the cited problem. Although it is the responsibility of the QCU to establish the QMS, a capable QMS and a continuous state of compliance rely upon everyone in the organization to do his or her part. Problems are often site-wide or corporation-wide, and it often requires multiple functions to collaborate. Unfortunately, the priority of one group is not necessarily the priority of another and initiatives stall from lack of support. Sometimes the lack of progress on a significant problem is barely perceptible. Regrettably, it comes to light too late when the same problem is detected at a subsequent regulatory inspection at the same or different site. The enforcement heat is turned up, and management is left wondering why all were not pulling together.

Aligning the organization to work with singleness of purpose to become a highly capable organization is one of the most important jobs of management and one of the most difficult. It is no less challenging for resolving cGMP compliance issues. The annual business planning process and performance management systems are often overlooked as management oversight tools for unifying support for important cGMP compliance initiatives, yet these processes are used throughout the industry to bring focus on the current priorities and to align resources. Tapping into the power of declaring what is important and rewarding achievement is a highly effective strategy for culture change by modeling and directing behavior since what is valued is rewarded.

The Opportunity?

So, what can be done to promote integration of cGMP initiatives into the business plan to affect meaningful change and achieve business results?

The answer is to use established QMS processes to identify the right initiatives, use established objective-setting processes to focus broad attention, and expect results because achievement is rewarded and there is accountability.

The following are important considerations when leveraging the business planning process and performance management systems as cGMP management oversight tools:

• Use the established quality management review and governance processes to identify cGMP highly leveraged improvement targets as site-wide objectives.

If designed and operating properly, the QMR and quality council processes will point to problems that require a significant attention and collaboration to improve predictable quality and consistent compliance performance. These established systems should be the basis for identifying data-driven improvement targets rather than creating new processes that may serve only to agree on dominant opinions at one point in time. Spend site-wide focused attention judiciously on initiatives that leverage exceptional benefits that can be annualized. Thus, annual planning objectives should be directed toward developing a more capable organization than fire-fighting projects.

• Partner with operations functions to develop mutually beneficial objectives.

The QCU is often criticized for not being interested in manufacturing efficiencies and productivity. Cycle times and unit cost are often considered business concerns, not quality or compliance. However, behind every inefficiency and lack of productivity could be a latent compliance problem. Consider, as examples, examining waste streams and permanently eliminating recurring deviations through engineered solutions. These are worthy targets of cross-functional collaboration as an operational goal. Every dollar of eliminated waste and redundancy is directly applied to the bottom line. The operation is more profitable and the cGMP compliance improvement is a side benefit.

• Manage the work and remove impediments.

Team composition with the right leadership, subject-matter expertise, and team skills are tremendously important. Facilitation, OpEx, and project management may be additional support roles needed but are not a substitute for pharmaceutical quality system management and regulatory compliance knowledge and experience. Project teams also benefit from senior-level sponsors who will champion the effort and help to remove stumbling blocks that devour valuable time and energy. Sponsors also jealously guard the teams’ time to allow them to get the job done and protect them from insidious administrative and dog-and-pony show distractions. However, most important is for the team to have a clear picture and alignment on what “done” looks like and how to tell when it is reached. This requires agreement on the vision of the future and how success will be measured. Both are anchors to keep teams from going adrift.

• Reward results, not the process.

Certainly, how work is done is important, and the tremendous effort by team members is appreciated. However, when it comes to compensation and public recognition, nothing less than accomplishing the objective should be rewarded. To do otherwise enables mediocrity and does not drive performance. Most important is to verify that the intended result was achieved in behavioral terms. In the cGMP environment, improvement initiatives usually result in changes to written procedures, yet, remember that changing words on a page does not necessarily change the behavior. Assess the performance metrics and records to determine if the objective was achieved. Capture the cost savings where possible to model compliance improvement as worthy targets that improve the bottom line.

Conclusion

This series has made the case for the intrinsic value to the business of compliance to cGMP regulations. Although there is a negative case to be made given the high stakes of non-compliance, the positive aspect of cGMPs as a business enabler is emphasized here. However, this is highly dependent upon the mindful and collaborative application of cGMP regulations by the QCU and the creation of an integrated QMS based on specific operational knowledge. Management has oversight responsibility of the QMS, which is facilitated by an action-oriented QMR and aligning the organization behind large-scale transformation objectives. Ultimately, through the combination of applying the underlying principles of cGMPs and the ongoing measuring, responding and learning from an effective QMS, additional benefits are obtained. These include accruing knowledge, preventing failure, enhancing organization capability, and increasing product quality predictability.


The QA Pharm

   

Part 4: Five Obstacles to Management Oversight of the Pharmaceutical Quality System

This is the fourth of a a five-part series that addresses underlying obstacles to management oversight of the pharma quality management system as evidenced by the continuing serious compliance and product quality problems in our industry. 

Part 1 dealt with the management perception that cGMPs are not relevant to the business, and it laid out the defense that cGMPs enable a predictable quality outcome that serves the business and its patients very well. 

In Part 2, the quality function was indicated to be in the best position to make the defense of the relevance, but all too often it has problems of its own and should be the focus of serious organization development. 

In Part 3, recognized that although management may be responsible for the quality system, they may not know how to exercise that responsibility. It is the responsibility of the quality unit to provide a forum where management can make data-driven decisions and monitor quality system performance.

But management oversight can still be handicapped if there are no governing bodies or processes to communicate regulatory compliance and product quality risks.

Obstacle 4: Governance throughout the Corporation does not Actively Review and Escalate cGMP Compliance Risks

When regulatory inspections turn up recurring violations, it becomes apparent that the company lacks the ability to permanently resolve problems that potentially or materially compromise product quality. The situation is exacerbated when FDA believes that unless the company is restrained, the company will continue violating regulations. In cases of consent decrees, it is a vote of no confidence in the management and the QCU; the effects are serious to the business. Penalty and remediation costs are extraordinary. A third-party consultant group is usually mandated to serve as a surrogate QCU with legal responsibility to review and approve investigation and batch records. The third-party conducts an extensive baseline audit and reports the findings directly to FDA. Consultants are retained to help lead a transformation of the QMS and the organization. Timetables to achieve milestones specified in the consent decree are aggressive, and additional resources flood in at an unmanageable rate. Delayed new product launches and disruption to market supply of existing products may be irrecoverable. Thus, corporations at the highest level cannot afford to be uninformed of cGMP compliance problems at any of its operations because the effect extends beyond a given operating site to the far reaches of the global network.

Governance in the broadest sense relates to how a company manages compliance to applicable laws and regulations. The term has come to mean self-oversight in areas that affect stockholders, such as accounting practices. However, cGMP compliance issues and operating in a state of control are also key issues that affect the profitability and viability of a company. The management agenda from operating sites to the corporate boardroom must effectively cover cGMP compliance risks, product quality implications, and regulatory enforcement action to get the true picture of company vulnerability.

The Opportunity?

So, what can be done to protect the extended corporate network from regulatory compliance risks that may exist at any given operating site?

The answer is to establish a governance process that creates a network throughout the organization that focuses product quality and cGMP compliance. The interdependence of the compliance performance among sites for consumer protection and the financial health of the company justify that there are governance boards to oversee this significant part of the business.

The following are features of an effective corporate governance body for cGMP compliance oversight:

•   There is a network of quality officers that represent each level of the company.

A top-level quality professional must be established for each level of the corporation. These typically are the operating site, the business unit, and the corporate levels. These individuals are designated as quality officers and have ultimate responsibility for the QMS and the QCU at their respective locations. A significant portion of their time is spent working together as a quality collegium to develop quality and cGMP compliance strategies for the company in an effort to support its current and future business. As such, evaluation of the personal performance of a quality officer is heavily weighted on their contribution to this collegium and effectively deploying its mission to their respective sites.

Quality councils are established at each level of the company to oversee matters relating to product quality and cGMP compliance. The local quality council is where the fullest understanding of process capability resides and initiatives for site improvement are driven. The quality officer chairs the quality council and membership is comprised of the ranking executive (e.g., general manager, president, etc.) and the functional department heads. The quality council should be a stand-alone forum in order to maintain the focus on a product quality and cGMP compliance agenda. The agenda should include topics such as establishing and deploying quality policies, review of regulatory inspection findings and verification of resolution throughout the network at a systemic level, setting quality goals and measuring progress, review of critical deviations and the status of associated corrective and preventative actions (CAPAs), and reviewing risks escalated from QMR and lower quality councils. Quality councils are focal points of knowledge assimilation and sharing.

•   A process and criteria are established to rapidly communicate critical issues.

The quality officers must establish channels of effective communication from the functional areas to the quality council and among the quality officers at all levels of the corporation. Conditions and criteria must be established for which direct and immediate escalation occurs. Although different for various levels of the corporation, the escalation criteria must be clear and embedded into quality council procedures. When it becomes necessary to exercise the escalation requirement, it is essential that it happens within a specified timeframe and is apolitical and unfettered by local approvals. After escalation has occurred, the added value is the assessment and mitigation of risk, notification to other sites, follow-up and network-wide verification, and closure.

•   Key quality metrics of importance to the corporate network are established.

During the course of the operation of the quality councils, the quality officers may determine key quality performance indicators (QPI) to be measured and reported across the corporation. The QPIs may vary year-to-year and focus on topics related to current FDA enforcement trends or areas of known recurring problems, such as supplier performance, recurring deviations, and CAPA effectiveness. Collecting corporate-wide QPIs is a challenge since sites are typically competitive and want to keep performance measures to themselves—or define the parameters and calculations to their advantage. Quality officers can address parochial behaviors by setting the expectation that their personal performance is based on working collectively as a quality officers in a collegium setting for the greater good of the corporation. A quality officer may wear a “site hat,” but the larger one is a “corporate hat” when the meet together as a collegium.

•   The corporation supports an Ombudsman program.

Ombudsman programs provide direct access between any company employee and a neutral third-party that takes reports of suspected conditions or activities that are illegal, unethical, or against company policy. Employee concerns about cGMP compliance fall into all of these categories and should be included in the program along with other areas such as finance, safety, and human resources. In order to preserve confidentiality and engender openness, the Ombudsman program should be managed independently by a third-party and coordinated by a neutral group such as the legal department. The quality officers and their respective quality councils will have a role to play in investigating and responding to reports.

The issues described thus far in this series have centered on management embracing the value of cGMPs and establishing the quality leadership roles and functions in order to organize, measure, and report on the performance of the QMS and govern this important aspect of the business throughout the corporation. However, some cGMP compliance problems may be so pervasive and entrenched that redirection of a large number of personnel and sites are required. The temptation is to embark on costly, trendy, and non-specific quality programs when some important tools are already on hand. In Part 5 we will look at leveraging these tools as a means of exercising responsibility and oversight of the quality system

The QA Pharm