Kevin Miodonski, Principal Consultant, GMP
The impact of management on an organization can take a company to new heights or lead it to its demise. Leaders of pharmaceutical, biotech and medical device companies have the added complexity of needing to meet regulatory requirements. For example in the United States, requirements implemented by the Food and Drug Administration (FDA) via industry-specific regulations (21CFR 211, 820, etc). These rules have been established to ensure a company performs in a manner that is safe and efficacious. So why is it that, even with the best of intentions, many companies that are regulated by the FDA receive poor grades in the form of 483 observations – and, to a lesser extent, warning letters and consent decrees?
Within the last three years, data shows that the leading 483 observation documented during FDA audits was related to inadequate procedures. This includes either a lack of procedures, not following procedures, or inadequate procedures. To ensure proper procedures are in place regardless of project stage, management teams must keep the following questions in mind:
Procedures (SOPs) do not write themselves:
- Who writes (or doesn’t know to write) the procedure?
Procedures do not train personnel:
- Is the training material and process sufficient to ensure personnel using the procedure understand its contents?
- Does the procedure have the appropriate level of detail to allow the personnel to apply the instructions consistently?
Procedures do not make products:
- When there is a lack of consistency in product quality, why is it that the production teams and operating equipment that make the products are not consistently successful?
We help guide pharma, biotech and medical device companies in the development of high-performing quality risk management systems and infrastructure. Our quality experts observe first-hand how organizations are negatively impacted when management teams lose sight of the necessity for continual quality systems maintenance and optimization. For companies of any size producing any type of medical product, here are our top three recommendations to ensure organizations maintain management controls that are built to continuously improve quality.
- Make the time and investment for recurring quality training and risk assessments. As Dr. W Edwards Deming famously said, “It is not enough to do your best; you must know what to do, and then do your best.” Many companies struggle with the failure of production-associated procedures, whether they are for operating equipment, performing a test or designing a new product. Most operational personnel, operational supervision and management want to perform to the best of their abilities, but can only accomplish what they are able with the skills and knowledge they possess. That effort needs to be coupled with the training and resources that management provided to meet the goals of the company. When the quality department is faced with a shortage of personnel, talent, budget or time, the staff in the department are left to prioritize projects that they or their managers deem most important to get the job done, which may or may not be relevant to the activities that best support the goals of the organization or even meet the prescribed regulatory requirements.
- Remember that there is no trade-off for quality. Management decisions regarding the allocation of budget directly impact what activities the company will and will not pursue. As management teams strive to maximize company performance on a fixed pool of resources, they make trade-offs to drive growth where it’s needed most. Some trade-offs include management trying to improve profitability by reducing the headcount and resources available to the quality department as they were viewed as an overhead cost. In more than one particular instance, the negative impact of such cuts in quality resources was not immediate, but over time many activities, actions and tasks that supported the company’s production of quality products were diminished. Without sufficient resources dedicated to quality oversight, there was an increase in audit findings, repeat audit findings and eventually, regulatory action was taken against the company in the form of warning letters and consent decrees.
- Enable a quality team that cures diseases, rather than treats symptoms. When poor quality brings an organization face-to-face with regulatory enforcement actions, many times the operative personnel are considered to be at fault, so the fix is to either write a new procedure, update the current procedure or perform additional training. If these fixes do not solve the problem, the common trend is for management to react by increasing focus and resources towards quality department. The additional budget allows the quality department to increase quality and procedural training and/or bring in consultants to help solve the issues and/or hiring of additional quality personnel. These are steps in right direction - but the questions should be asked:
- How did the quality management system get to that point? Have the right personnel been involved?
- What roadblocks exist that cause gaps in quality management?
- Why are these symptoms repeatedly appearing on audits?
Ultimately, companies need the right quality personnel with the right expertise in order to allow the rest of the organization to successfully perform the tasks required to meet the companies’ overall goals.
To strengthen the overall quality of final a product, pharma, biotech and medical device organizations can start with strengthening their management control system. This enables senior leadership to be more aware of the state of compliance, makes quality infrastructure known throughout the organization, and heightens expectations that all activities and all products produced have to meet their customers and the various regulatory agencies expected level of quality.
Wondering where to go next?
If you're looking for strategies to assess your quality management system, we're here to help. At your convenience, one of our quality experts will answer your urgent questions around building a quality infrastructure that fits your business. During a complimentary meeting, we'll help you identify gaps and opportunities, then develop an action plan that's built to ensure your product development operations achieve the highest quality.
Attention West Coast! Our GxP Quality and Validation experts will be at the 34th SQA Annual Meeting in Anaheim, CA. Stop by our team at booth #206 to learn how Advanced Clinical helps organizations avoid quality risks and stay audit-ready.