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

Part 2: Responding to FDA483 Observations and Fulfilling Commitments

Part 2: Organizing to Get the Work Done

Responding to FDA483 observations was my focus in Part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation.

In Part 2, I share my views on getting the work done to fulfill the FDA commitments. The following have become benchmarks from those who are the best at getting the job done in a sustainable way and getting the problems behind them:

• Form teams. This might seem obvious, but forming cross functional teams representing stakeholders is often overlooked. The solution will very likely involve creating different ways of working that cross functional lines. It is a rookie mistake to think that the fix is something for the Quality Department to do on its own, or just an editorial change to a procedure. Depending on the problem, the team may need to be dedicated to allow focus, particularly if accelerated timelines are involved. Include subject-matter-experts that have the scientific, technical, and cGMP backgrounds to provide appropriate guidance.

• Use consultants judiciously. Consultants can provide valuable additional support. They should bring relevant industry experience that can help scope the project and give practical advice that keeps the project moving toward the solution. The best consultants are good listeners who can help you design the right solution that works for you. But, if the only team members that show up to meetings are the consultants, something is terribly wrong. Do not outsource your responsibility to consultants. Let them help you, but it's your company and you own the results.

• Determine the deliverables. Many teams go off the rails because they fail to determine the tangible deliverables that address the problem. You cannot grasps the degree of effort, determine the resource needs, or estimate the timeline until there is a clear vision of what "done" looks like. If you cannot describe "done," then you do not know the problem well enough.

•  Solve the problem, not just the Commitment. Make a careful assessment of what it will take to prevent recurrence of the observation, not just satisfy the specific commitment. The FDA always states in the FDA483 that the observations are just examples and are not all-inclusive. Companies are expected to determine all that is necessary to permanently resolve the problem that underlies the observation wherever it applies. Perform a root cause analysis and ensure that the solutions are operational and sustainable. That invariably involves more work that the narrow view of a specific example cited in an observation or the response given.

• Determine how you will know the problem is solved. In true fashion of a CAPA, determine how you will measure effectiveness. What will tell you that the solution worked? What will be your first sign that it did not work? Consider whether this is yet another attempt at solving the same old problem. Remember that recurring observations lead to increased levels of enforcement. Be sure you know the problem is truly solved.

• Avoid Information Technology (IT) Solutions. This may sound a bit strange, but in my personal experience, nearly every commitment made in a FDA483 response that involved an IT solution missed the commitment date by light-years. I know that it should not have to be that way. I'm just saying that in my 20 years of consulting experience, that has always been the case. Consider applying an IT solution as a later improvement, not within the commitment time line if at all possible.

• Use Project Management Principles and Tools. Quality System development work is not like a capital project where much of what is needed to estimate the time and cost is known upfront. Quality system and compliance projects are more often like exploratory surgery where a lot is learned once you open it up the patient. You may discover that multiple linking systems are affected after you start looking at the problem more deeply.  Recognize that plans will need to be adjusted along the way. Do not confuse progressive revelation with scope creep. Be adaptable. Establish plans and reports based on the work and target dates, not subjective feel-good dashboards with perpetual dates that slip. Anticipate problems with hitting the date and mitigate them before failure is a foregone conclusion. When you see that the timeline is slipping, ask for help and consider first what it will take to get back on track. Don't just keep moving the target date back as the default solution.

• Provide Infrastructure Support. Remediating compliance problems often require new ways of thinking, not just new ways of working. Compliance problems frequently go hand-in-hand with company culture problems. Progressive companies that recognize the business value of an effective Quality Management System also recognize the opportunity that regulatory inspections provide to examine its culture and values. Change management coaches can help a company adapt to the changes required to support a quality and regulatory compliance culture. Recurring compliance problems are frequently a culture problem that discounts the value of an effective Quality Management System and regulatory compliance to the business. 

• Provide Management Support. Ensure that each project team has a sponsor who is the best fit based on the functional owner of the process being remediated. Clearly identify the role of the sponsor and ensure that it includes removing obstacles such as lack of organization alignment, stalled decisions, team dysfunction, and inadequate budget. Sponsors are the champions who are willing to delve into the level of the working team to provide visible support, rather than sit on the management team and undermine their own folks at project update meetings. Being sponsors of quality system remediation projects provides a unique opportunity for function heads to understand dependent processes across functional lines.

• Establish Governance Oversight. The work associated with fulfilling commitments is tightly connected to managing risk. Thus, it is important to keep site governance councils frequently updated with progress and informed about unacceptable risks. These risks always include the risk of meeting a commitment date made to the FDA. Take commitment dates seriously. Other unacceptable conditions uncovered along the way should also be communicated to the governance body. Establish clear lines of communication and escalation between the team that actually does the work and governance. Learn how to escalate and resolve potential problems quickly. Nothing consumes the timeline as much as reluctant escalation and indecision.

• Verify that Deliverables Solve the Problem. Take an independent look to ensure the work is completed and that the tangible deliverables are in-place and in-use. This is a good role for an independent consultant. It is far better to find out for yourself that the mark was missed than for the FDA to call it to your attention as a repeated observation. Be a healthy skeptic and ask, "How do we know for sure the problem is permanently solved?"

• Revisit Commitments. Although you may have verified that the solution is in-place and in-use, revisit the problem at an appropriate time interval to ensure that the organization has not reverted to the old ways of working.

How have you managed regulatory commitments? What are your success stories? What have been epic failures, and why?

The QA Pharm

If You Need a Burning Platform to Justify Change, You Must Like Firefighting

Often times pharma has a split personality. One personality loathes firefighting, and the other personality needs a burning platform to justify doing anything that requires spending money.

Go figure.

This becomes evident in our industry when some companies cannot part with a pittance of their multi-billion dollar profit to establish or ensure that an effective and sustainable Quality Management System (QMS) is in place--along with suitable facilities for intended use and sufficient staff levels.

This is really obvious when such companies are at the heart of the devastating drug shortage problem. The burning platform appears in the form of regulatory enforcement action, disgorgement and penalty fines, consumer stakeholder lawsuits, loss of goodwill from patient advocate groups, and a drop in stock price.

A burning platform you want? A burning platform you get.

But what about the patient? 

The patient deserves better. No company can claim to put the patient first without solidly and confidently knowing that an effective QMS is in place, in use, and providing the data-driven evidence that you are operating in a state of control. 

But that is way too boring. 

It is much more exciting to emerge victorious from the daily firefights. The person who rescues the baby will always get more recognition than the schmuck who goes around changing the batteries twice a year in the smoke detectors.

So the next time you hear someone say that there is no burning platform to motivate spending the money, investing the capital, or authorizing the project, tell them it is too late when the platform is on fire. Make the business case that the QMS and other worthwhile quality / compliance projects are an investment in ensuring a reliable supply of quality products to desperately needy patients. 

You will always spend more money at the most inconvenient time and under the most impossible timelines when you have to react to a crisis. Smart companies know how to anticipate a problem; not react when the damage is done.

Waiting for the platform to burn ends up scorching the patient.

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