The most critical feature of successful and compliant management systems is continual commitment from a company’s senior management. As their commitment strengthens, the system will correspondingly become more robust and adaptable. Without adequate management commitment, even the most well-planned and elegantly executed management system will experience flaws and serious failures.
Management systems are a fact of life and an irreversible trend in the new millennium. What is still not resolved is the type of system to apply—either a robust system that addresses the letter and spirit of the regulations or a system that is limited to a "minimalist" approach, one that superficially covers the regulations to a level sufficient only to pass audits and reviews.
No rational person, experienced and knowledgeable in quality management and working in the best interest of his or her organization, would reach the conclusion that a minimal compliance strategy is appropriate. How do we, as professionals, effectively communicate these truths to the senior management of our organizations? Too often, these fundamental nuggets of wisdom have been casually dismissed as "bureaucracy" or "quality propaganda" by individuals who have different business agendas. A major requirement of effective management systems is obtaining buy-in and support from critical parties—an art that demands the highest level of presentation and communication skills.
My approach is to express the potential risks arising from a minimal compliance strategy and to demonstrate how the company that takes a more proactive position can become more adaptable and responsive to changing regulations (scalable approach).
In general, product regulations are lagging indicators of the potential loss to society arising from error conditions or improper use of the product. Regulations should be expected to increase to reflect new discoveries about product flaws.
Products are constantly used in innovative or modified operating environments. A limited compliance strategy will not be suitable to address changing regulations.
There is little marginal cost between the minimal level of compliance and a robust level. After the overhead of testing and documentation is addressed, the differences are negligible compared to the payback and benefits (particularly in preventing claims and lawsuits).
Products found noncompliant can be confiscated and ordered destroyed, without compensation to the organization. All of the input costs are unrecoverable.
A sound process takes a bundle of inputs, adds value, controls the risks, and delivers a meaningful transition in multiple operating environments. Regulatory requirements are incorporated and embedded into the workflow without disruption.
A minimalist process does not account for all of the risks and requirements in the design and validation of processes, and the required records and documentation flow are unnatural and burdensome. Important information is not collected and is not communicated to the necessary parties.
The corrective responses required to recover from compliance failures include reworking, retracing, redesign, and redundant documentation. The accuracy of such efforts is diminished due to delays and other risks.
A minimalist approach sees compliance as an avoidable expense, which should be reluctantly approached and discontinued at the first opportunity.
Resources that must be procured externally are more expensive than those obtained through training, competency, and internal design. The premium for external consultation and intervention is increased when there are time pressures for achieving compliance.
Noncompliant facilities can be shut down and rendered unusable. The capital costs for those facilities would then be unrecoverable by the organization.
In a robust management system, all personnel act as the eyes and ears of the company. They are trained, competent, and aware of their responsibilities and requirements. As a result, personnel are constantly monitoring and addressing issues.
A minimalist management system discourages assertive and diligent work methods. This culture demands the retention and maintenance of the status quo. Issues are considered compliant until proven noncompliant (quality assumption rather than quality assurance).
Since training is not reinforced or refreshed, levels of competency and understanding decline over time, resulting in increased exposure to the risks of human error, negligence, or misconduct.
In minimalist systems, regulations and regulators are seen as adversaries, who must be challenged or deceived. Instead of preserving the integrity of products and processes, personnel become adept and astute in diversions, shortcuts, and methods to misrepresent the status of the company.
From these examples, one can see that the short-term gains of the timid and hesitant "minimalists" would be severely undermined by the costs and risks of such a strategy. Those who would advocate a minimalist approach do a tremendous disservice to their profession and place their organizations at considerable risk. To the "minimalists," I would suggest they increase their level of training, competency, and commitment to the profession or else leave the profession and pursue a vocation like selling used cars.
I call upon all practitioners to unite in support and collaboration with this approach. One weak link in the chain has severe causal effects on related organizations. Compliance to the letter and spirit of the law is a rational approach that benefits everyone, and it is the quickest, cheapest, and easiest way to manage your business.