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

Weekly CGMP Quiz 9: Part 211 Subpart I Laboratory Controls. Use with Your Team for Training Credit!

This is the ninth of eleven quizzes on CGMPs that will appear about weekly here at QA Pharm. Try it yourself and use as a discussion tool for your staff groups.

Also, each quiz will have one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all eleven quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

An answer key will be provided after the eleventh quiz to use for further discussion.

Click on image below:

10 Points to Consider Before Becoming a Pharma Consultant

I am often asked for my advice on entering the consulting field, and I am happy to share my opinion from my own personal experience and what I have observed.

So here are 10 points to consider:

1. Family support is essential. You will be away from home most weeks. If you are someone with a young family; someone who likes to make all the decisions at home; someone who has a partner that has difficulty having you away from home---don't go into consulting.

2. Be financially stable. The consulting world is becoming more competitive and hourly rates are declining in many specialty areas. If the next on-time paycheck is critical for survival; if you cannot be without an income for six months--don't go into consulting.

3. Form your business entity. Don't mix personal and business money. Protect yourself by forming some type of a corporation. Talk to a accounting advisor who can listen to your unique situation to determine the best option for you. I am a "C Corporation," but make your decision on your needs, not what other consultants do.

4. Be realistic with your skills. Determine what your product is and refine it into tools, methods, approach, etc. Clients will readily detect when you have overstated you expertise. While it is acceptable to hone your skills and accrue more experience when consulting, it is not acceptable learn the subject on the clients' dime.

5. Charge by the hour. Consulting is typically billed by the hour, not the job. You have more control. Some clients may never agree when you are done.

6. Show something for your work. Agree upon deliverables with the client. What does "done" look like? Develop a common understanding of the client support required for the project to succeed. Know when you add value or not. When you no longer are adding value and just billing hours, discuss with the client. Warm-body-consultants give consultants a bad name.

7. Market through people who know you. Most projects come from people who know you directly and personally. Hopefully you have been building a network throughout your career from places you have worked and professional conferences. Being out in the consulting world is not a time to start thinking a network.

8. Be a consultant, not an employee. Study the IRS test rules for determining the difference between and employee and an independent consultant/ contractor. Don't allow either yourself or the client to cross the line emotionally or legally. If you feel you are "going to work" like you have all your life, you are not consulting.

9. Keep careful records. Not all clients require time and expense records. You should require it for yourself. Keep every cotton-picking receipts and a meticulous record of your hours: what you do and time. Never, ever pad the expense report or bill unreasonable hours.

10. Build-up, not tear down. You are there to help, not criticize. Avoid coming across as a "know-it-all". Lead the client to the point where they internalize and embrace your teaching. Find those among your client personnel who have that unexplainable spark, mentor them, and leave a legacy.


The QA Pharm

Ownership Responsibility for the Pharmaceutical Quality Management System: Setting New Expectations

In Texas we have an expression: If it's left to two people to water the horse, the horse will go thirsty.

Our quarter horses are well-watered because of established roles and responsibilities around the ranch. But I am no longer surprised that in the pharma industry it's not that easy to point to who is responsible for what when it comes to the details of the quality management system.

I typically get one of two responses to the question, "Who owns the [fill in the blank] system?" Whether it is Training and Qualification, Deviation and CAPA, Document Management, Complaint Handling--or whatever-- it's the same:

• Ultimately it is the Head of Quality, or
• What do you mean "own" (or responsible) exactly?

Sure, the Head of Quality has the ultimate functional responsibility, and in the sense of the Park Doctrine, the CEO has the penultimate responsibility. But that is a neither practical or effective.

I published an article that discusses the importance of identifying clear ownership at the operational level for each element of the quality management system and the benefits to the business when new expectations are set.

Follow this link to read the article on IVT Network-->  Ownership Responsibility

I hope you find this article beneficial. Write to me, or post a comment to this blog and tell me what you think.

The QA Pharm

"Murder for Diversion" The first Jacob Blake Pharma Mystery by John Snyder

I started the QAPharm Blog three years ago as a creative outlet to share my perspective on the pharma industry and the quality assurance profession. I have appreciated my faithful readers from dozens of countries around the world.

As many of my readers have noted, I took a hiatus from blogging for a year. During that time I wrote the first "whodunit" murder mystery ever set the the pharmaceutical industry.

Murder for Diversion by John Snyder is the first Jacob Blake murder murder mystery, and it is available at Amazon for your Kindle. I hope you enjoy it.

Just like my blog, it is infused with my experience in the pharmaceutical industry, but it is a true work of fiction. All places, events and characters are the product of my imagination. 

Here's a little bit about my book and protagonist Jacob Blake.

Jacob Blake is reinventing himself.  He's an expert in pharmaceutical manufacturing quality, but his career and his life is at a crossroads, when an uncle dies and leaves him property in, of all places, Texas. He drives cross-country, thinking that maybe this is a sign, a direction for him to go.  But his old life calls, and his ex-boss and nemesis in Philadelphia asks him to take a look at a mystery.  His first inclination is to not look back, then his old boss is suddenly dead, leading Jacob into a world of shady dealings, and murder.  This is the first in a planned series looking at what the public doesn't know about how the drugs they take every day are made and following a character in his journey of re-creation and life renewal. 

So, if the book was written by John Snyder and I am QA Pharm, then QA Pharm must be John Snyder.

I hope you enjoy the book and continue to check in with me here at The QA Pharm. 

I am very happy to know you.

John Snyder
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

   

Cartoon: The QA Pharm, Myrtle the Change Control Coordinator (Part 2)

I introduced The QA Pharm Cartoon about Myrtle the Change Control Coordinator on December 14, 2010. Little did I know that it would become the fourth most viewed page in this blog.

Here is the next installment of life down on The QA Pharm. 

(Go back to Dec. 14, 2010, for the start of the story.)

Be gentle. I'm not an artists, but I hope you enjoy. 

The QA Pharm

Part 2: Five Obstacles to Management Oversight of the Pharmaceutical Quality System

Part 2: Five Obstacles to Management Oversight of the Pharmaceutical Quality System

This is the second 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. The quality function should be in the best position to make this defense, but all too often it has problems of its own.

Obstacle 2: The Quality Function Does not Fulfill its Regulatory Responsibility and is Detached from the Operation.

The QCU is the only pharmaceutical function that is established by the Code of Federal Regulations. It is required to exercise its regulatory mandate without a conflict of interest. Part of its responsibility is to establish the QMS, which, as described above, contains the body of procedures that declare how the company intends to operate in compliance with cGMPs. However, too often the QCU develops procedures in isolation, and the rest of the company is willing to let them do so. Without collaboration and integration with the business, the procedures will be disjointed and invite “workarounds.” In these cases, the QCU may actually contribute to compliance problems. Thus, the cycle continues and cGMPs are viewed as being disconnected from the business—primarily because they are.

The quality function has a responsibility to lead the effort to establish a compliant QMS that efficiently applies to the operation. Both are required to be competitive. The modern-day quality organization must have the ability to protect the business from compliance risks as well as the ability to be integrated with the business. It is not an adversary empowered by a sense of external authority, nor does it cross the line and lose its independence and objectivity. Rather, the QCU is a partner whose role adds a valued perspective. However, the quality organization may not have the skills to assess how to apply cGMPs to differing operations or how the QMS must evolve to meet the changing mission of the plant site.

The Opportunity?

So, what can be done to establish a business-integrated QCU that fully meets the intent of cGMPs?

The answer is that management must challenge the QCU to a higher performance level by establishing an organization development strategy. The strategy must include an objective assessment against factors critical to its success.

Critical success factors for the pharmaceutical QCU include:

• Roles mandated by cGMPs for the QCU are incorporated into the QMS and are faithfully practiced.

The regulatory mandated roles of the QCU center on its authority to operate independently and objectively as a reviewer and approver of matters related to cGMPs. This includes procedures, specifications, nonconformance and complaint investigations, and product release into the market. Such authority does not preclude collaboration with other functional departments and subject matter experts. The reporting relationship and financial incentives for the QCU must not create a conflict of interest.

Non-regulatory activities that divert time from their primary responsibilities should be challenged and properly positioned in the organization. For example, the QCU should not be the training function or the validation function simply because training and validation are important cGMP requirements. This would create a conflict of interest where the QCU would be approvers of its own work. Rather, the training and engineering departments must know how to apply cGMPs to the practice of their respective professions in a pharmaceutical company, and the QCU review and approve their procedures and records.

• QCU professionals have a working product and process knowledge.

Product and manufacturing process knowledge is essential to fulfill the responsibilities of the QCU. An effective review of procedures, batch records, and investigations is not possible without a fundamental understanding of the science and technology of the product portfolio. It is far better to transfer and promote experienced manufacturing personnel into the QCU who have demonstrated the ability to apply and practice cGMPs than to inbreed QCU personnel.

Compliance without product and process knowledge becomes legalism, and the QCU is often reduced to an administrative function that becomes distracted by minor issues; the significant risks that require management attention are lost in the noise.

• The QCU has the skills of quality science, not just cGMP compliance.

Engineers, microbiologists, chemists, and pharmacists have defined curricula for their professional degrees. The pharmaceutical quality professional may have a scientific or technical degree; however, there is no defined body of knowledge that is widely accepted across the industry to equip the QCU. Many individuals start as bench chemists or microbiologists and rise through the ranks. Many build their resumes by transferring between companies. Others are recruited from companies with high visibility compliance problems to benefit from their remediation experience.

Management must consciously enhance the core skills of the QCU to enable it to operate from product development through technical transfer and to daily manufacturing. They must know how to measure and control variation as well as understand the effect of change on a technical level. They must possess tools to assess risk, reduce waste, and calculate price of nonconformance. The QCU must know how to speak the language of finance and risk management to make the business case for its proposals using polished presentation skills. They must not continually resort to the scare tactics of presuming to know exactly what FDA does and does not like.

Even with a top-notch QCU and a QMS that effectively and efficiently supports the business, there is still the possibility that compliance problems will evade the attention of management without a formal review mechanism. In Part 3 we will look at the effectiveness of the Quality Management Review process.

The QA Pharm