At a Glance
- The definition of quality has evolved with changing business dynamics, particularly in regulated industries such as pharmaceutical, chemical, and food & beverage.
- The Pharmaceutical & Drug industry witnessed a 168% increase in drug approval by the FDA in 2018 compared to 2016, testifying the growing quality adherence among manufacturers.
- Compliance to quality guidelines is only getting more stringent with time. Pharmaceutical & Drug industry also saw high rejection (73) through 2018 including Recalls, Market Withdrawals, & Safety Alerts, highlighting the importance of quality standards set by the industry watchdog.
- While quality is increasingly becoming an integral part of modern-manufacturing practices, our research revealed that some organizations continue to devalue the importance of quality to a mere afterthought.
Quality plays a pivotal role in the success of a business and is no longer considered an impediment to a successful business. It’s often that the release of a product for shipment is delayed due to standards not being met, causing stress on the customer service reps working closely with Customers.
Saying yes to sub-standard ‘products to the market’, however, are catastrophic, with damages that could at times be irreparable. Companies that are embracing modern-day Quality Management are supporting technology initiatives. Successful businesses ensure that the right systems are in place to allow a product to pass all quality checks.
This article highlights a small section of Quality Management related to processes and systems. The intent is to help businesses understand how technology has evolved with the changing business landscape and how manufacturers (in any highly regulated industry) can leverage technology such as the One-Microsoft ecosystem to stay relevant, and ahead of competition. In this article we will discuss Quality Management holistically, and follow it up with the finer aspects of Quality Management in subsequent posts.
FIGURE 1 Classification of Quality Management
The Evolution of Quality Management
Quality management has evolved from being an afterthought to becoming a rigorous self-discipline that most modern-day manufacturing companies have taken onto themselves. What used to be quality control in the 1960s has evolved to become “total quality control” in its present form. The US FDA is tightening its norms to ensure higher quality standards, and companies are responding to such challenges by increasing their quality standards. The below timeline depicts how the definition of quality has evolved over time since the 70s.
FIGURE 2 The Evolving Definition of Quality Management
Process Improvements in Quality Control
Improvements always start by first understanding the issues that reside in a department. Following are some typical activities in the Quality control department of a Pharmaceutical company:
- Manage Quality control tests
- Manage Quality control specialists and their workload
- Allocate and calibrate test instruments
- Establish appropriate test methods
- Document test specifications
- Perform tests in the order of priority and
- Accurately record test results.
Trending and analysis, as well as stability studies, would be a follow up of quality data that is captured for understanding the reliability of manufactured batches. This is just a quick and simplified view; in reality, all of the activities listed above have many details involved. Ensuring that all processes and procedures are handled with precision ultimately reflects on how well you are able to maintain the quality standards.
Processes in the Quality Department
A typical day in the life of a Quality control department could start with lab analysis and paper requests to perform quality tests on a sample batch size. At times it could be multiple batches for different products that are either produced in-house or received from 3rd party manufacturers. The Quality lab prepares test instruments for each test and accurately records the test results along with any digitally signs-off for each work order. If we were to take a quick view of what is involved in ‘getting it right’, our understanding of all essential requirements for an optimal quality process could change.
Use cases with digitization and automation have demonstrated a more than 65% reduction in deviations and over 90% faster closure times.”
It involves having all the SOPs opened up in front of you to perform a test with precision and not allowing any deviation in process unless the ‘method to deviate’ is clearly spelled out. It is challenging to hold the people in your department compliant to a process unless there is a stringent system in place. If the system is paper-based, you are adding laborious tasks with corrections and piled up paperwork. Every time an audit occurs, it would require digging through so many stacks of paper to bring out the right answers.
FIGURE 3: A Central Filing System to Manage Documents and Information
Quality Control Systems
Pharmaceutical companies that are implementing an electronic system need to decide how tightly the system has to be built. The process could add discomfort to users due to various systemic restrictions, or an uneasiness around user errors.
People could start feeling anxious about making mistakes, as every change would have a digital stamp tied back to the person modifying the data. It could also get a bit cumbersome to fix errors in retrospect while using a controlled and validated system that is 21 CFR part 11 compliant.
The idea is not to add discomfort but to build the right kind of habits in users. Ideally business users need to be given enough information about how the overall system works. A well-planned training plan can help the users move from discomfort to being champions – promoting the process in the organization.
Anyone with a basic understanding of compliance would prefer an electronic system instead of a paper-based process, for the strength and ability to capture data as is. It then requires a change in mindset of ‘ continuously fix errors’ to ‘proactively do it right in the first place’. At the end of the day you want to foster efficiency in your whole organization. This can be achieved by evaluating a reliable process that could be quickly adapted by your department.
Elimination of up to 80% of manual documentation work will improve productivity.
Quality Management Challenges – What Does a Plant Manager Look for?
A Plant Manager would have a specific view of the business as their purview is not restricted to one department but to the overall operations of the plant. Some key concerns that typically need to be addressed by a Plant Manager or a General Manager of Plant are:
- Quality Management
- Compliance with evolving regulatory standards
- Take control of your Documentation such as COA
- Corrective and Preventative Actions management (CAPA)
- Location directives
- Raise flags when two reactive chemicals are placed in proximity
- User Adaptability and training to conform to the new Quality standards
These concerns are typically addressed by:
- Efficient Document Management – allows you to centralize documents into a secure repository that is seamlessly accessible. This ensures quicker decision making and effective change management. It also helps in ensuring visibility of your documents, enhances traceability by tracking amendments, and document safety with revision control features.
- Addressing Non conformance – can be done through a unified platform to log non conformance, quality of incoming raw materials, complaints, delay, etc. This helps in addressing compliance at an early stage, paving the way for course correction and registering the same in the system.
- Corrective & Preventive Action – a method with advanced analytical features built in to help you learn and unlearn from records of the past. As discussed, registering a non-conformance incident into the system initiates a workflow for corrective measures. This system learns from past incidents and recommends preventive action to control similar incidents from recurrence.
- Implementing the right kind of tools and technology can help with Process automation and reduce data entry errors along with tracking process efficiency.
Identifying the right system to help make the most impact will be the first essential step to move in the right direction. Once that hurdle is crossed, it is important to build a ‘to be’ mindset instead of worrying why the system doesn’t do what your workforce is used to doing. Evaluate how stringent you want your process to be, based on your company’s needs and accommodate a well-defined method that is native to the application.
- Quality management is no longer an afterthought and has evolved to become a discipline in most prosperous manufacturing organizations. Quality management which was once considered as a business function that hindered speed to market and product launch, is now embracing modern technologies to fuel innovation, bring in efficiency, eliminate the scope of incidents within a plant, and offer better predictions for the future.
- Pharmaceutical companies that have evolved to modern, automated quality control systems are able to empower their workforce to rapidly adopt process improvements and optimize all the functions in the department.
- The adoption of better tools in one department typically sets the standard for the entire ecosystem, including functions such as regulatory compliance, procurement, demand management, research & development, inventory and warehouse management, etc.
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