The Crack in the Wall: Unintended Consequences of Authority

I remember when I was a freshly minted executive taking a window tour of the manufacturing facility. While listening to a staff member talk about the operation, I idly traced my fingertip on an ever-so-slight mar on the finish of the corridor wall, as I was lost in thought. Little did I know the chain of events that this little action would set off. By the time of my next walk into the manufacturing facility, the entire corridor was freshly refinished.

It often is with executives: a simple word, glance or unconscious pause—in my case the mindless wandering of my fingertip—has surprising effects.

Once there was a pharma exec that stated flatly that certain software was the company standard. Little did he understand that an alternative software that was justified and better suited to a unique situation had been in play for months. But his comment set off a fury of activity by dozens of employees that worked tirelessly over months to convert the data and retrofit it into the awkward “company standard” at great expense and loss of precious time and effort to deliver on commitments to the FDA.

In another example, a pharma exec questioned the timing of a purchase order request for a controlled temperature chamber for the stability program. The simple question of timing sent the requisitioner back to try again next quarter. Little did the exec know that this equipment was needed to fulfill a commitment to the FDA, and that there was a six-month lead-time to acquire it.

With authority comes unintended consequences: the rank-in-file hesitates to question it or push back on it.

Rather than creating a situation where the humble creatures fear to approach the mighty Oz, it would be helpful if the executive would take time to invite conversation about the request.

However, shame on the person who fails to make the business case, and the person who walks away fully knowing the unintended consequences of the denied request.

I have never met a company executive—whether a blustery curmudgeon, or a charismatic leader—who does not speak the language of money; who does not abhor squandering resources; or who is not willing to pay now to avoid a problem with the FDA tomorrow—when the proper business case is made. (Well—almost never.)

And—where was QA during the countdown to the day of reckoning with the FDA?

Fear is alive a well in corporations. But fear is really the result of the lack of confidence; not being prepared; absence of skills to defend a point-of-view; and often haunting memories of boogey men of the past. In short, it’s lack of conviction and courage.

Debate is productive. Contrarians sharpen the decision process. We would all do well to encourage it.

The QA Pharm

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 Top Ten Reasons the Deviation Investigation System Fails

For some companies, manufacturing is a crapshoot. There is little basis for confidence that that the right equipment, materials, components, people and records will be at the right place and the right time to begin manufacturing. And once manufacturing has begun, a crystal ball is as good as anything to divine whether the product batch will be released on schedule.

Manufacturing is a continuing exercise of muscling and cajoling the product from one stage to another while the zealous QA department chalks up one deviation after another that sends the minions scattering about to do the minimal essential work required to release the product to market.

Deviations and the associated CAPAs begin to amass and backlogs soon become the ominous specter that one would just as soon explain away just as Scrooge did his night visitors.

This scenario is nothing less than a testament to an out-of-control situation, and deviation investigations are nothing more than slight-of-hand or putting the best face on recurring, nagging and relentless problems.

There is always time to crank out the perfunctory deviation investigations, but never enough time for leaders to emerge to mindfully gain control of the situation through conscious understanding of the underlying causes for the mayhem and carve a path forward out of the wilderness. Rather, management decries the onerous GMPs that burden the business while patients are desperately waiting for your magnanimous supply of lifesaving drug.

Warning Letters are fraught with observations that point to issues with the deviation investigation system and the ability to solve problems once and for all. Here are my top ten reasons that the deviation/investigation/CAPA system fails:

1.   R&D throws half-baked processes over the fence to operations, saying that they did their part to file a submission to the FDA ahead of the competition. Now it’s time for Operations to take over in the spirit of continuous improvement.

2.   The event occurs and is opened in the system, but there are delays in gathering time-sensitive information. It is not until the time gets close to release the product that open deviations surface and stand in the way. Unfortunately, no one has accurate information to assemble the facts for a meaningful investigation.

3.   Products impacted by the deviation are not evaluated based on scientific data, and the perimeter is not drawn wide enough to include anything beyond the current batch—and certainly not to anything released into the market place.

4.   The true root cause or most probable cause is not determined by a disciplined approach, and is not documented. The root cause reads more like a problem statement, or the symptoms of the problem. The bottom of the problem is not reached, and will surely stop short if the true cause touches on a politically sensitive subject.

5.   Significant deviations cannot be distinguished from all the minor issues flooding into the system. When every single documentation error is entered into the system with its corresponding investigation and CAPA, it’s no wonder that there is a backlog and meaningless activities working at cross-purposes.

6.   Deviations are seen as singular events, rather than yet another example of a problem that is already identified as a deviation in the system. There is no “look back” to determine if the new event is already covered by a current effort, or the evidence of an ineffective CAPA.

7.   Inappropriate ownership for deviations leaves QA with a conflict of interest. The areas responsible for causing the deviation have no incentive to permanently resolve the problem, because they know that QA knows the “right way” to write it up to get the lot released. QA “rationalizes” rather than independently assesses the “justification.” (See The QA Pharm 10/30/10.)

8.   Performance metrics are not presented to management for review in an action, decision-oriented forum where assignments are made, followed-up at subsequent reviews, and individuals by-name held accountable for results.

9.   Because TrackWise (an excellent system) provides visibility to problems and serves as a tracking tool, junk gets into the system for those two reasons only (visibility/tracking) when in actuality they are neither a deviation, nor a CAPA. Events going into data management system must meet the definition of a deviation, and there cannot be a CAPA without first having a root cause.

10. There is a tolerance for repeated problems.

How do you score against these top ten reasons?

The QA Pharm

Internal Quality Audits: Valuable or False Security?

Most pharmaceutical companies have an internal CGMP auditing program administered at the site and corporate levels of the organization. Auditors are typically part of the Quality Assurance or Regulatory Compliance function, and the usual approach is to examine the data trail to determine whether company policies and procedures are followed.

But is this enough to tell you what you really need to know about the state of your Quality Management System (QMS)?

In my opinion—no. After all, there are many pharma companies under an FDA Warning Letter that have internal audit programs.

Why is this?

In my opinion, internal quality audit programs fail because:

1.    Consideration is given only to the system in-place, not whether the system complies with current industry practice and FDA expectations.

2.    Auditors have been in the job too long and have acclimated to what is in-place, not what should be in-place.

3.    Auditors tread too lightly in politically sensitive areas.

4.    Audit responses fall short of the true root cause, particularly when it involves company culture.

5.    Associated CAPAs are not effective, and repeated observations are tolerated.

6.    Senior management does not adequately support the audit program as a priority.

I truly believe that the internal auditing process has tremendous potential to serve the organization. However, the internal auditing program and its auditors need to step out of their classic methodology and venture into new ways of adding value to the company.

In my opinion, a powerhouse for ensuring an effective Quality Management System (QMS) would be created if internal quality auditors were to compliment the QMS “ownership” concept.

I won’t repeat myself here about Quality System “Ownership.” (Please see The QA Pharm 12/18/10.) Suffice it to say that the independent role of the auditor assessing whether the features of quality system “ownership” are present and effective would add much more value to the organization.

Rather than publishing a list of typical observations, auditors would assess the strength of the backbone of the compliance sustainability strategy—“ownership and accountability.”

Thus audit observations—for supplier quality system, as an example—would read more like:

1.    Ownership for the supplier quality system has not been established since John Doe was transferred out of the role nine months ago.

2.    The planned versus executed supplier audits is behind for critical suppliers by six audits. This metric was presented at the management review, but no action was indicated or taken.

3.    The quality performance metrics for the supplier quality system indicate an upward trend in the number of suppliers with overdue audit responses. This metric has not been reported to the Quality Council as required by the management review procedure.

4.    Employees in the incoming inspection department have not been trained on the supplier quality audit procedure as required by their training curriculum. A role is defined for incoming inspection personnel in the supplier quality procedure.

Get the idea? The “Auditor” supports the “Owner” by assessing whether the “ownership behaviors” are effective.

The result is an audit report that not only points to the compliance issues, but also reflects on the state of ownership and accountability.

We really need this in pharma. Lack of ownership and accountability is endemic.

The QA Pharm

Fire Fighting Pharma

I am convinced that there is an element in some pharmaceutical companies that enjoys the adrenaline rush of a crisis. These are the people who descend upon problems and save the day through sheer grit and determination. They work late and weekends to pull the proverbial baby out of the fire.  They are known as having a “can do” attitude, and nothing gets in their way to get the job done. This is their life day-after-day. They receive great praise for their selfless commitment to the company by doing whatever it takes to fix a situation, and to (typically) muscle the batch of product out the door.

But have you ever noticed that they are the last people on earth who are interested in being involved in preventing the chaos in the first place? No, because they thrive on chaos. What’s worse is that these people get promoted further cementing the fire-fighting culture in place.

Meanwhile, there are the unsung heroes who go through their normal day changing batteries in the smoke detectors, checking to see that fire extinguishers have sufficient pressure, and generally making sure that the wiring meets code and that the circuits are not overloaded. In other words, devoting their attention to whatever will prevent a crisis.

How boring. There is no glory in that.

Has fire fighting become the norm? The chaotic environment is like Brownian movement where work is accomplished by the random collision of activities. To finish quicker—just turn up the heat on the already crazy atmosphere.

Prospective employees are screened on their ability to work in a chaotic, volatile environment where priorities shift daily and their planning horizon is barely a day ahead. They’re told they must possess the ability to “go with the flow” and multitask, and any personal projects or assignments will need to be done before or after normal working hours and on weekends. The politically correct term “nimble” is used to wrap the craziness in a progressive business buzzword.

Now…think about this from a patient’s perspective. Is this where you would want your life-saving drug manufactured?

I think not. There’s a regulatory expression for this: out of control.

Give me the boringly predictable—the consistent, sameness, no surprises, no daily fire alarms. But, for starters, that would take leadership with technical skills who know their way around the shop floor.

I have a vintage Coca-Cola advertisement that shows bottles of uniformly sized and filled bottles streaming off the line. The text reads: “Continuous Quality is Quality You Can Trust.” That is so true.

Predictability breeds confidence.

I wish you an operationally boring 2011.

The QA Pharm