Remedy or Transform
Remediation or transformation? Who would have thought such a simple question, as I had posed in a recent LinkedIn post, QMS Remediation or Transformation?, would bring such a spirited (online and offline) response? Some people do not believe there is a difference. There is, and it is significant.
Additionally, a May 4th, 2019, New York Times, editorial opinion article was referenced in the feedback: 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices, with a byline that reads “Patients suffer as the FDA fails to adequately screen or monitor products.” Wow, the FDA failed?! How is it ignored that it is primarily the manufacturer’s responsibility to monitor and guarantee the safety and efficacy of the medical devices that they market? The FDA CDRH mission, vision and shared values are clear, and they don’t have the profit motive that the medical device companies do. The responsibility to address nonconforming product in the market belongs to the medical device manufacturer. (Please see the Appendix to this document for detailed information about Field Safety Corrective Action if you would like additional detail that informed my previous statement.) This should occur when a device is identified that poses “an unreasonable risk of substantial harm to the public health.” 
The medical device industry should embrace the position that FDA CDRH seems to be relying less upon enforcement as the primary mechanism to influence behavior, and are becoming focused upon forwarding the progress of a medical device industry to instead pursue a ‘culture of quality’ to achieve better results. That paradigm squarely places the primary burden to monitor and guarantee the safety and efficacy of medical devices where it belongs… with the medical device manufacturer.
Remedy or transform? There should be little debate. Remediation is reactive and transformation is proactive. Remediation of a Quality Management System (QMS) is required once systemic failure has been identified. Remediation of a QMS is typically resultant from enforcement activity and indicative of a failure of responsible persons to adequately control the ‘quality’ of the QMS to ensure the proper measurement, management and improvement of product and process quality. It’s true. No company wants to voluntarily remediate FDA-483 issues under duress, and at risk of further escalation in the form of additional enforcement actions the Agency may use beyond FDA-483 observations. An FDA-483 is the document that the FDA issues at the close of an investigation when they identify and enumerate observations of noncompliance to regulatory requirements during an FDA inspection.
It is important to understand that a very formal communication process has begun with the issuance of FDA-483(s) that has legally placed the company on notice that there is a problem. The FDA-483(s) issued and the ensuing Establishment Inspection Report (EIR) that is written by the Investigator(s) to fully document the investigation are actually evidence to be used if further enforcement actions become necessary. Once issues of noncompliance to regulation were identified, the inspection became an ‘investigation’ to collect evidence of violation(s) of the law. Violations of the law can then lead to a variety of enforcement actions.
An FDA-483 observation is only an initial enforcement action, the documentation of a violation. This is done to formally notify an inspected establishment’s top management of objectionable conditions relating to products and/or processes, or other violations of the Federal Food, Drug, and Cosmetic Act and related regulations, that were observed during the inspection. If the inspection had gone well then no observations would have been made and no FDA-483(s) would be issued. Once issued, systemic remediation, under significant and 3rd party scrutiny, creating significant organizational duress is now required. Additional enforcement actions are also possible. Depending the nature of the violation(s), the FDA may give Firms an opportunity to take voluntary and prompt action to correct the violation before the FDA initiates an enforcement action, however, the Agency generally is under no legal obligation to warn individuals or Firms about violations before taking additional enforcement actions, as further described below.
Untitled Letters are enforcement actions used for violations that may not meet the threshold of regulatory significance for a warning letter and request correction of the violations. Unlike a warning letter (described below), an untitled letter does not include a statement that warns the individual or Firm that failure to promptly correct the violation may result in enforcement action.
Warning Letters are enforcement actions used for violations that meet the threshold of regulatory significance to request correction of the violations with a statement that warns the individual or Firm that failure to promptly correct the violation may result in additional enforcement action.
Judicial Actions include product seizures or removing violative products from the market when there is a perceived or known health risk to the public and injunctions to enable the FDA to stop or prevent a violation of the law when a violative Firm fails to follow through on their obligations. The three most common types of injunctions are the temporary restraining order, the preliminary injunction, and the permanent injunction.
Needless to say, it is in the best interest of the Firm to provide a timely and adequate response to ‘remedy’ any and all FDA-483 issues of noncompliance to regulatory requirements so as to avoid any further escalation in enforcement activity.
Once a company has just experienced an FDA Inspection, and one or more FDA-483 observations were noted, or worse yet a Warning Letter was just issued, the organization must become fully aware about the remediation process that has begun, understand their responsibilities associated with an adequate and timely response, and take immediate action to address the identified observations of noncompliance.
Actions are required to remediate the FDA-483 compliance issues identified in addition to any other issues that were self-identified by baseline compliance audit. Remediation plans are made, and the results that are expected to be obtained by the remediation plan are solely dependent upon “responsible officials” (of the Firm), who are in positions of authority to ensure the necessary measures are taken, as was previously referenced from the FDA Regulatory Procedures Manual
“Responsible officials in positions of authority in regulated firms have a legal duty to implement whatever measures are necessary to ensure that their products, practices, processes, or other activities comply with the law. Under the law such individuals are presumed to be fully aware of their responsibilities.”
The appropriate resources must be allocated by management with executive responsibility within the Firm to ensure results are obtained, as indicated within the plan submitted.
Goals and objectives are then set and communicated. Failure to meet these remediation goals and objectives can be devastating to the credibility the Firm in the view of the Agency. However, if it becomes evident that the Firm may fail to meet the timeline for an established goal or objective it is important to immediately communicate with the FDA to explain the circumstances and provide updated objectives. No surprises, transparency is important. Be absolutely certain, however, that the new commitment date(s) are attainable and in alignment with the reason(s) the extension is required. The FDA will typically agree to an extension of time when informed that original objectives turn out to be unreasonable. Take caution, as this should not become a pattern. Credibility is obtained by demonstrating responsibility through your actions, and in achieving the milestones set forth within the plan that was provided. If the Agency identifies repeated patterns of failure to meet your commitments and/or ongoing noncompliance as identified in repeat findings within additional surveillance audits, an escalation in enforcement action(s) is likely.
Effective execution of the remediation plan should result in the objective evidence of the containment, corrections, and corrective actions of product and process issues associated with the observed FDA-483 deficiencies. Subsequent surveillance auditing by the Agency should then result in no further, or repeat, FDA-483 observations.
That, in essence, is the process. Just writing about the process of remediation gave me heartburn, however, I went through all of that just to make sure everyone is on the same page about what ‘remediation’ activity entails. I only provided the short version. Remediation is certainly not fun, and it can seriously impact the medical device company employees who work hard and expected an outcome that was more in line with the typical company rhetoric about ‘quality’ and ‘saving lives’ with the products they produce. They certainly deserved more than they got from the irresponsible leadership that gave rise to the quality issues causing remediation activity to overtake the company’s operations in the first place. The company was forced into remediation activity because of the burning platform, created by inadequate quality management.
The burning platform…
“It was fry or jump, so I jumped.” - Andy Mochan
Andy was a survivor of a massive oil rig explosion who chose probable death over inevitable death during an emergency, and thankfully emerged unscathed. The story features a man, named Andy Mochan, who worked on an oil-drilling platform in the North Atlantic. The platform caught fire while he slept, and he woke to find himself trapped by flames. Confronted with dire options, he chose to leap from the platform into the icy waters below. The business analogy that has been associated with this is known as The Burning Platform. The insinuation is that companies will only act when there is a compelling reason to do so, such as in response to FDA enforcement activity. In business, however, emerging from the emergency completely unscathed is not actually going to happen. The impact to the business is always profound. It takes many years to recover.
When significant changes are made as a result of a remediation program, they are always accompanied by some level of disruption and chaos to the business. Additionally, the organization is not built for such an event and doesn’t have the required resources and people to get the job done properly, and in a timely manner. The need to “get back to business as usual” is overwhelming, and the work never gets done properly as a result. Short cuts are taken because the medical device company is typically still in charge of the remediation program.
Fortunately, many business “emergencies” such as this can both be foreseen, and also avoided. Many people only associate change with problems, acting when something is broken and needs to be fixed. The reality is that every company has opportunities available to them today to proactively fix or improve their operational constraints, enabling incremental improvement. If not addressed individually, and on an ongoing basis, these opportunities accumulate until they inevitably become an overwhelming business emergency such as was described above.
In today’s business and regulatory environment, managed and ongoing improvement is essential to business growth, and survival. Medical device manufacturers can actually avoid emergency remediation activity if they take steps to do so today. The first step requires a simple paradigm shift.
Paradigm shift for the avoidance of emergency remediation…
The paradigm shift that must occur to avoid exhaustive remediation programs, and proceed to drive change without a burning platform, requires an organization to first realize that compliance is only a single component of achieving a ‘quality’ outcome. Compliance ≠ ‘quality’. Compliance is not the first and/or primary focus of ‘quality’, nor will compliance alone achieve a high quality outcome.
To begin the quality journey and pursue a culture of quality that transcends an outdated and underperforming culture of compliance, your Firm must endeavor to improve of the system of management that is used to manage the ‘quality’ of the Firm’s products and processes. Doing so will demonstrate your Firm’s commitment to patient and user safety. Responsible leadership must actively and formally decide to make improvements in the system of management that is used to manage the ‘quality’ of the Firm’s products and processes, and be proactive in doing so. There is no reason to wait, and ‘now’ is the right time to act.
These are times of extraordinary change for the medical device industry, and a perfect time to re-consider the strategic quality plan the organization pursues. Risk management and quality management must almost be considered as synonymous terms in today’s environment, as they have significant interaction with one another. The European Union Medical Device Regulation (EU MDR) PRRC responsibilities make it essential to conduct Post Market Surveillance (PMS) and Quality Management System (QMS) surveillance activities. Medical device companies have an obligation to ensure their PMS and QMS surveillance systems are state-of-the-art for regulatory and business stakeholders alike, and most importantly… for the patients and users they serve. These systems provide the foundation for quality management activity. They must be strategically re-considered first.
The PMS feedback processes is also referred to in EN ISO 14971:2012, risk management, as necessary to maintain the safety and performance of medical devices. In addition to the pre-market assessment of risks associated with a new device, EN ISO 14971:2012 specifies requirements for production and post-production information to be considered as part of the overall risk assessment process throughout the life of the device. The directives, in conjunction with the harmonized standards, form a framework for manufacturers to develop a comprehensive feedback system intended to ensure the continued safe-use of a device for the manufacturer’s intended purpose.
Additionally, the FDA CDRH ‘Benefit-Risk Enforcement’ guidance document discusses the consideration of the understanding and management of unanticipated harm and identified device nonconformities in association with compliance enforcement decisions.
Finally, EN ISO 13485:2016 provides an outline of a quality management system (QMS) structure which compels the need for a feedback system specifically to provide early warning of quality problems and for input into corrective and preventive action processes.
Responsible leaders must consider all of this in establishing a new strategic quality management plan. Within this era of unprecedented change, Leaders must adopt a new paradigm regarding how ‘quality management’ actually occurs, and is managed by the people who work within the company. Accountable leaders have more responsibility placed upon them now than ever before, requiring a high-performance Quality Management System (QMS) to enable the delivery of the operational results that their stakeholders expect.
Additionally, beyond a clear patient centric safety focus, there exists ever increasing market pressures due to dynamics associated with the healthcare payer system that will demand economic value on a fast approaching horizon. A patient centric focus that delivers both safety and value will require absolute management control to ensure the satisfaction of regulatory stakeholders and business stakeholders alike. A paradigm shift, away from a reactive culture of compliance, and towards a proactive culture of quality requires a strategic plan to proactively measure, manage, and improve product and process quality if it is to be successful.
Now we turn our attention away from the dark side of change (remediation) and look on the bright side of change (transformation)…
A proactive transformation of the QMS to consistently manage and improve the QMS requires an entirely different paradigm… and a new strategic plan to make it happen. The benefits of such a transformation can be significant. Amidst change, there also exists opportunity. Opportunity to transform the QMS into a system that truly ensures extraordinary performance and provides real business value while doing so. Additionally, transformational change is not managed as a massive program. Instead, it is managed through a strategic plan that takes predictable steps to address those things that must be addressed first… not everything at once.
There is a book about ‘transformation’ within the baseball industry called Astroball, The New Way to Win It All. The book basically explains how a new leadership team overcame the bias inherent in the human observation needed to form the basis of their player decisions. They challenged the aspect of decision-making, necessary to building their roster, with the goal of producing a world class baseball team. They did this through being better informed. The Astros utilized information/data to improve their decision-making process and they improved their ability to objectively manage player/personnel decisions by utilizing that information. Additionally, they trained their players with that information to focus them on the outcome they desired. This resulted in going from ‘worst to first’ and winning the World Series.
The Chicago Cubs followed in similarly transforming their organization’s operations, and had the same result… they won the World Series. Although it is an entirely different industry all together, the lesson is the same and can be utilized by the medical device industry.
The ‘way to win it all’ within the medical device industry requires the pursuit of a culture of quality within the Firm and the improvement of the system of management that is used to manage the ‘quality’ of the Firm’s products and the QMS work processes and production processes that create them. This system of management must be capable of identifying the most detrimental ‘quality’ constraint(s), such that each effort initiated to fix or improve product and process quality is just is what is most beneficial to the Firm in that moment in time. Transformation doesn’t occur with a massive program that exhausts the organization. Transformation occurs with steady and organized efforts that energize the organization with improved compliance, effectiveness and efficiency. The efforts associated with improving quality constraints are ultimately rewarded with a return on the investment (ROI) associated with each project.
The transformational pursuit of a culture of quality within a Firm is a steady and ongoing journey. It involves the implementation and execution of a strategic plan to enable the Firm to identify and address the issues and constraints of the system, in order of importance to the Firm. It provides the people who are responsible for stakeholder satisfaction an improved capability for management control through focused measurement, monitoring, reporting, and review of the ‘quality’ of products and processes.
Quality Management Systems have become incredibly complex, making them more difficult to manage with outdated methods. The Firm’s strategic plan (assuming the organization currently has one) for measuring, managing and improving the ‘quality’ of products and processes must be updated to improve the management of the Quality Management System, and/or systems. Quality System(s) Management (QSM) is a transformational strategy that provides the responsible people with improved management control over the Quality Management System (QMS) through focused measurement, monitoring, reporting, and review of the ‘quality’ of the products and processes. QMS management with a QSM strategy will transform the culture of an organization into one that operates within a ‘culture of quality’, and creates high-quality products.
Product ‘quality’ is an outcome of Quality Management System (QMS) process ‘quality’ in conjunction with production process that are executed from within QMS control. The Quality System(s) Management (QSM) solution strategically provides the quality management necessary for control over the QMS, utilizing data technology, and enabling responsible decision makers to continually improve the ‘quality’ of QMS processes, production processes, and the products produced.
A industrial revolution is underway within the medical device industry. It is a revolution that requires the merging of human talent with technological capability to enable organizations to leverage data-driven insights for improved business performance. Medical device companies must improve their analytics maturity in order to improve the process ‘quality’, that creates the product ‘quality’, that drives patient outcomes… and they must do so urgently. The Mgmt-Ctrl QSM solution merges strategic design with the technical approach and technological data processing solutions that are associated with the PMS and QMS surveillance capability that is now required of the medical device industry to better manage product quality.
It is our mission to support patient care by improving product and process quality within the medical device industry through the provision of our Quality System(s) Management (QSM) solution. The QSM solution strategically provides the active measurement of product and process quality to identify and report the systemic constraint(s), enabling the responsible management of emerging issues and the ability to act in the facilitation of continual improvement initiatives. The Mgmt-Ctrl QSM solution is currently available to medical device companies for the implementation and utilization of analytical technology methods that facilitate the active measurement, interactive management an continual improvement of product and process quality.
We would like to help medical device companies begin their quality journey, enabling them with a transformation strategy that will provide the extraordinary results their stakeholders desire, in producing high-quality products that the patients and users rely upon.
“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” origin unknown
Principal and Chief Quality Officer
 LinkedIn, Larry Mager, May 6th, 2019, QMS Remediation Transformation, https://www.linkedin.com/feed/update/urn:li:activity:6531131776214142976
 New York Times, May 4th, 2019, 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices. Patients suffer as the F.D.A. fails to adequately screen or monitor products, https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html
 FDA CDRH Mission | Vision | Shared Values, https://www.fda.gov/about-fda/about-center-devices-and-radiological-health/cdrh-mission-vision-and-shared-values
 H.R. Rep. No. 853, 94th Cong. 2d Sess. at 21 (1990), Congress in discussing the meaning of this standard stated: In determining whether a device presents “an unreasonable risk of substantial harm to the public health” the Committee intends that the [FDA] consider such factors as the severity of the harm presented by the risk, the cause of the risk presented by the device, and the number of devices in commerce which present the risk. “Substantial harm to the public health” may include widespread non-serious harm to a large number of persons as well as serious harm to a few individuals.
 Merriam-Webster, https://www.merriam-webster.com/dictionary/remedy
 Merriam-Webster, https://www.merriam-webster.com/dictionary/transform
 Inspection Observations, https://www.fda.gov/ICECI/Inspections/ucm250720.htm
 US Food and Drug Administration, “Inspections, Compliance, Enforcement, and Criminal Investigations Manual, Subchapter 5.2 – Inspection Procedures.”
 Untitled Letter, https://www.fda.gov/iceci/enforcementactions/ucm511995.htm
 Warning Letter, https://www.fda.gov/iceci/enforcementactions/warningletters/default.htm#browse
 Judicial Actions, Chapter 6 of the Regulatory Procedures Manual, https://www.fda.gov/downloads/iceci/compliancemanuals/regulatoryproceduresmanual/ucm074317.pdf
 Advisory Actions, Chapter 4 of the Regulatory Procedures Manual, https://www.fda.gov/downloads/iceci/compliancemanuals/regulatoryproceduresmanual/ucm074330.pdf
 Peter Ross (15 June 2008). "The night the sea caught fire: Remembering Piper Alpha"; On July 6th 1988, 167 lives were lost in what has become known as the Piper Alpha disaster
 (EU) 2017/745 of the European Parliament and of the Council, 117 Official Journal of the European Union 1 (Apr. 5, 2017) [hereinafter EU MDR]
 EN ISO 14971:2012, Medical devices – Application of risk management to medical devices
 Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-regarding-benefit-risk-medical-device-product-availability-compliance-and-enforcement-decisions
 EN ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes
 Ben Reiter; Astroball, The New Way to Win It All, https://www.amazon.com/Astroball-New-Way-Win-All/dp/0525576649
 Advanced analytics fuel tomorrow’s commercial strategy for drugs and devices, March 16, 2019; https://www.pwc.com/us/en/industries/health-industries/health-research-institute/commercial-pharma-analytics.html