Seven Signs that Your Quality Program Is in Troubleby Ellen Leinfuss, SVP, Life Science, Kaplan Eduneering

For Quality Professionals

Product quality problems don't happen overnight, nor are they the result of a crippled procedure or one poorly conceived policy. The problems have brewed over time, sending out signals that risks to product quality are growing.

Because of the unique nature of medical products and the expectations of prescribers and patients, failed product quality translates into a betrayal of trust. It is a safety and brand issue, and problems are on the rise, as evidenced by the 300 percent increase in drug recalls experienced this past year.

A breakdown of quality is not an event. It is a process. Long before a quality failure explodes on the front page of the New York Times, a company's quality system has been in trouble because of corporate decisions, policies and programs. In this paper, we identify the following seven "signs" that often indicate future quality problems and offer guidance in addressing associated challenges.

There is no substitute for a powerful "tone at the top" but recent corporate crises have shown that tone by itself is not enough to support quality. Companies widely considered to be the quality leaders in their fields have been battered by quality problems, in part because of a disconnect between the company's message to the public and to its own employees. Toyota has become an iconic example of this "message disconnect." According to industry experts, Toyota's leadership set a blistering production pace at the same time it systematically slashed operating costs. Despite the public statements of leaders reiterating the company's legendary commitment to quality, Toyota's policies sent a very different and clear message to employees and suppliers: quantity and cost trump quality. The consequences of that unspoken message were played out this year through massive recalls and investigations by national enforcement agencies across the globe.

In many companies, the contradiction between what is said externally and what is instituted internally is less obvious or intentional. David Spong, President of the American Society for Quality (ASQ), offers a telling example of one company's careless quality message to employees. As a way of reducing its operating costs, that company shuffled departments to maximize the use of space. While Finance, Operations and Strategic Planning retained their offices, the Quality Department was banished to a room originally built to house computer servers.

Reflecting its original intent, the room was separated from other offices, equipped with raised floors and climate controls but lacking even basic amenities of a modern departmental office. Company leaders continued to express their historic commitment to quality, but the message to company employees and, in particular, to quality professionals came through loud and clear: Quality is a "fringe function," not an essential, high-level company priority. When staff rumblings were recognized and the quality department was moved to a prominent location, overall employee morale lifted and performance improved.

The example given by Dr. E. David Spong demonstrates the importance of aligning the tone at the top with the actions in the middle. Employees will quickly see the frailty of "quality as a core value" when company leaders downplay the role of quality professionals and the company's internal quality practices.

In our experience working with hundreds of companies both inside and outside of life sciences, we have seen dramatic improvements in employee performance when quality is treated as a corporate priority. The objective is to change behavior by weaving quality into all corporate policies and practices, not only as an intrinsic value but also as a visible priority in business policies and practices.

Some of the best practices we recommend are giving quality a "seat at the table" in senior management meetings, on par with financials; addressing quality and compliance at all key meetings, with tangible and measurable actions defined for each operational level; setting clear metrics for quality and compliance, often tying those goals to management bonuses; and continually reinforcing the quality message through communication and education.

In early 2010, an FDA Warning Letter noted a common failure of life science companies to have "...sufficient personnel with the necessary education, background, training and experience to assure that all activities required by 21 CFR 820 are correctly performed..."

According to FDA's letter to the company CEO, the Director of Quality Systems lacked the required B.S. in a science, technology or engineering discipline, instead holding a degree in business administration; the Regulatory Affairs Manager position was filled by an individual who lacked the required five years of regulatory experience; the employee holding the Quality Control Supervisor position lacked the required educational degree or alternative five to eight years experience in quality control; and the person holding the Calibration Coordinator position lacked the required educational degree and four years of relevant experience.

Although these failings were blatant, many companies lack an adequate system that allows managers to conduct gap analysis; identify inadequacies in training, education or required certification and licensing; and establish actions to remedy the situation. Not surprisingly, the qualification issues raised by FDA were among many violations identified in the company's quality program.

Today, regulators ask companies not only to show training records, but also to demonstrate that individual employees have the requisite qualifications to perform their jobs. These qualifications can be confirmed through CVs, a robust newhire program and training records that align specific curricula with individual roles and responsibilities, all integrated in a single learning management system.

Some of the companies we work with are going a step further by implementing operator certification programs that require training before an employee is given access to production equipment via biometrics or card-swiping tools to authenticate users. These programs involve straightforward technology integration between the learning management system and the process equipment and system, which can range from batch recordkeeping to API quality testing.

Whether by design (organized as subsidiaries, operating companies or divisions) - or through tradition (often a strict, hierarchical organizational structure), many life science companies have created siloed organizations that inhibit communication, collaboration and consistent practices across the enterprise, particularly in the areas of quality and compliance. This results in disparate quality programs across the global facilities and the entire supply chain responsible for these products.

The FDA is particularly concerned with the silo mentality that prevents companies from identifying enterprisewide problems through accurate root cause analysis and transparency among facility managers and leaders. In early 2010, FDA's concern was documented in a Warning Letter to a pharmaceutical company for significant cGMP violations. In its letter, FDA expressed its concern in clear terms.

"The...2009 inspection uncovered several violations that are identical to those found during a... 2008 inspection..." of another facility owned by the company." Referring to the company's repetition of the same violations noted previously at another plant, the FDA wrote, "These identical cGMP violations demonstrated a lack of adequate process controls and raised serious questions regarding your corporation's quality and production systems." As a result, both sites were placed under an import alert and product detention.

The corporate silo that shields corporate officers from "routine" issues present in their organizations can pose multiple risks, most notably in what an officer is liable for knowing about his or her organization and how it is functioning. The FDA and DOJ are now ratcheting up the prosecution of individuals, including company CEOs and Directors, for illegal actions committed by employees under their control. As control officers, corporate leaders may be vulnerable to criminal charges, even if they had no knowledge and did not participate in, the alleged violations.

Convoluted lines of communication in any organization can be problematic. With quality failures posing the greatest threat to a life science company's reputation and sales, and with enforcement agencies' expanding view of individual liability, the line of communication between a company's officers and its quality department becomes critical.

We have seen several positive actions recently that deserve consideration for all companies. One is the appointment of a Chief Compliance Officer with reporting responsibility not only to the President, but to the Board of Directors. The CCO spearheads an organization of senior compliance and quality directors with enterprise-wide responsibility. A second trend is the elevation of the quality function to the senior staff level, reflecting the emphasis of senior management on quality. In 2010, more companies appointed Vice Presidents and Senior Vice Presidents of Quality than ever before. This assures that quality issues will be brought, unvarnished and unfiltered, to the attention of corporate leadership.

An interesting observation has come to us from FDA inspectors about siloed corporate officers. According to their comments, corporate officers are routinely absent from meetings with inspectors or investigators.

Quality and compliance should be priorities for a company's leaders, those same leaders would be well-advised to be involved in the auditing and inspection process. The signal it sends - not merely to the troops but also to regulators - is that the company's officers are hands-on, that they are aware of what is going on inside their organizations, and that they are personally committed to ensuring quality and compliance.

The harsh economic backdrop of 2008-2010 has intensified the urgency for companies to identify potential cost-cutting opportunities. Often, maintaining equipment and facilities is seen as "low-hanging fruit" that can be reduced without undue risk to operations. Routine maintenance and housekeeping lack the sophisticated image of advanced technology calibration but their absence has spelled product quality trouble for more than one life science company.

A recent Warning Letter paints a grisly picture of the interrelationship between facility maintenance and product quality. "Your firm received 21 consumer complaints in 2008-2009 for the presence of foreign materials in five finished products (e.g., insects, insect parts, and spiders). Upon receipt of these complaints, you concluded that the foreign material could not be attributed to your firm's manufacturing process." FDA was not impressed with the company's response, explaining curtly, "FDA considers contamination of finished drug products with foreign material (e.g., insects) a significant product quality issue."

The Agency went further, "In addition, you should include a plan for determining additional potential sources of these foreign matter complaints and may need to audit your suppliers of raw materials and packaging components." Other companies have been cited for product quality failures because of paint chips, metal shavings, contaminated water, rust, dust and dirt found in products.

Beyond FDA, OSHA has become more attuned to issues at life science companies, as evidenced by the recent $357,000 fine for "alleged willful and serious violations of workplace health and safety standards." In this case, worker exposure to carcinogens was the basis of the OSHA violation. Whether or not the OSHA violation will spill over into FDA's GMP violations remains unknown, but there is an unquestionable trend among federal and state agencies as diverse as the Securities and Exchange Commission, the FDA, the DOJ and OSHA to share data and resources in enforcing federal law.

FDA's GMP Regulations are clear: equipment and facilities must be designed, validated, controlled, calibrated, inspected and maintained according to written procedures. Records of these activities must be maintained. Properly designed, installed, maintained and cleaned equipment and facilities will produce products that meet their intended specifications.

We have been told by FDA investigators that they specifically look at housekeeping issues-from the cleanliness of the external facility to asking to inspect random offices for piles of paper, boxes of materials and dust atop a filing cabinet. Lax policies and procedures not only send the message to employees at an individual facility that carelessness and unsanitary conditions are tolerated but are also likely to trigger inspectors' concerns about the company's other facilities.

A worker in today's sophisticated medical product manufacturing facility may be responsible for understanding hundreds of Standard Operating Procedures. The SOPs may be revised several times a year, and each revision requires new training to ensure compliance. Beyond SOP training, employees will be subject to training programs for various types of certification, continually shifting regulatory requirements, safety and ethics standards, and corporate expectations. Most often, each training element is developed and conducted independently, often using incompatible technology platforms, schedules and formats.

An uncoordinated approach to training creates multiple problems that can pose substantial quality risks. Incompatible technology prevents training from being easily extended across the enterprise. Uncoordinated scheduling easily creates training overload, with employees unrealistically expected to simultaneously learn, retain and apply vast amounts of new knowledge. A failure to accurately tailor training with the knowledge needs of individual employees will waste employees' time as well as corporate resources.

Effective training is a priority issue under multiple state and federal laws, whether it applies to quality or to worker safety, governance or sales and marketing. It is no longer adequate to simply "provide" training; rather, the standard set by laws, regulations and the US Sentencing Guidelines is that the training be "effective," meaning that learners understand and are able to apply the new knowledge. Our experience with life science companies shows that training programs frequently fail on multiple fronts. Programs fail to test employees and document their understanding; they do not provide remedial training for employees who fail to demonstrate competency; they apply inadequate oversight to quickly identify those employees, departments or training elements that fail to deliver the required results. Finally, they are based on "providing" training rather than on the behavior change that is the real goal of any effective training initiative.

Recently, the US federal government has become focused on ensuring that training is provided in the language understood by learners, increasing the importance of providing training in multiple languages. That requirement exists for facilities inside the US with multi-cultural workforces and for foreign facilities operated or contracted by US-based companies. Quality products are the result of quality- conscious actions by individuals throughout the production process, regardless of location.

Kaplan EduNeering is routinely asked to fix neglected or outdated training programs. These experiences with hundreds of life science companies have shaped the best practices we recommend to enable behavior change, improve product quality and meet regulatory requirements.

First, companies must develop a process to keep training content accurate, up-to-date and reflective of the most current thinking of regulators. As one example, our long-term relationship with the FDA enables us to provide our clients with the same, reviewed content used by FDA to train its own inspectors.

Second, courses and related educational material must be based on sound instructional design that drives engagement, understanding and knowledge retention by learners. Use of inconsistent materials pull learners' attention away from the subject matter, which consumes company resources and reduces the likelihood of behavior change based on new knowledge. Testing is an essential component of each training assignment. Employees who test successfully are then permitted to advance to the next level of training; employees who fail to meet the established test completion standards should be provided with remedial instruction and testing - not simply passed through the system.

Third, materials must be tailored to the knowledge needs of the target learning population, based on each group's language, literacy, job function and compliance requirement. Particularly important is effective new-hire training. Even the most experienced new employee or subcontractor cannot be expected to know a company's established standards or procedures without well-developed onboarding activities.

Fourth, because product quality is the "sum of its parts," not simply the result of one high-performing facility or department, consistent training should be implemented across the organization to establish a standard foundation of enterprise-wide knowledge. Additionally, many companies are now extending their training programs to subcontractors, suppliers and consultants. The brand company is in the bulls-eye for any liability associated with failed product quality, no matter where or why the failure occurs.

Finally, "quality training" goes far beyond "quality topics" to include SOPs, compliance updates, corporate Codes of Conduct, safety and equipment calibration. Inaccurate, out-of-date or missing SOPs represent one of FDA's most frequently cited GMP violations for life science companies. SOPs form the basis of GMP compliance, product quality and operational efficiency.

Accurate, up-to-date records about employee training, competency and qualifications are essential to regulatory compliance. They are also critical to effective management of operations, personnel, resource allocations safety, productivity - and quality. Despite their central role in business management, critical records are often trapped in a netherworld of inefficient processes and conflicting technologies, forcing quality managers to grab vital information "on the fly." Current, specialized technologies are available to create a cohesive bank of records that is easily accessible, available in real time and configurable to the changing needs and parameters of any individual organization.

An effective system for accurate recordkeeping that meets compliance and serves as an essential operational tool for managers requires both financial and human investment. Today's tough economic climate is often cited as the rational for postponing or curtailing this investment but it is a flawed rationale likely to produce serious management failings. Critical documentation of required training goes "missing." Managers are unable to identify, in real time, who knows what (and, just as important, who doesn't know what) and to target necessary responses.

Quality professionals are especially impacted by inadequate or nonexistent record management systems that link data from across the entire organization. Without that system, it is virtually impossible for a senior corporate compliance or quality manager to ensure that lessons learned at one facility are communicated to the rest of the organization or that training required on one production line is repeated at other facilities using the same processes. FDA is taking a broad view of quality and compliance, looking beyond individual violations at single facilities to question operations throughout the enterprise.

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