December 31, 2013 Kamaal Anas, Vice President Regulatory Affairs, Wright Medical Technology
All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.
There are three proverbs/curses, attributed to the Chinese, that are applicable to many regulated companies, (1.) May You Live in Interesting Times, (2.) May You Find What You Are Looking For, and (3.) May You Come to the Attention of Those in Authority.
May You Live In Interesting Times
Generally speaking, regulated industries are facing increasing instability. Contributing factors include a loss of intellectual property rights, declines in R&D productivity and product pipelines, increased spending pressures on R&D and manufacturing, increased product complexity and compliance requirements, and increasing competition. Requirements are increasing and profitability is decreasing.
In response to increasing instability, many companies respond with knee-jerk reactions by directly and/or indirectly cutting quality. Facilities and equipment upgrades and improvements are delayed, preventive maintenance is reduced, and requalification periods are extended. Personnel hiring is frozen, employees are laid off and critical functions are outsourced to the lowest bidder. Processes are streamlined without thought to their effects on the entire system. In short, instead of trimming fat, cuts often reach the bone.
May You Find What You Are Looking For
As a result of across-the-board cuts, many companies obtain short term profitability, maintain or increase their share prices, and management obtains their year-end bonuses. However, these across-the-board cuts often leave insufficient infrastructure to maintain and sustain minimum quality standards.
May You Come to the Attention of Those in Authority
One has only to scan the news to find companies that have lost billions of dollars to recalls, reductions in market share, fines and consent decrees, and management with executive responsibility named as defendants in criminal proceedings.
Quality has a cost, but poor quality is costly.
Costs of Poor Quality
There are many visible costs of poor quality, including reprocessing, increased inspection, scrap and warranty payouts. There are many more hidden costs of poor quality, including administrative costs; unpredictable P&L; buffer inventory; lost sales; decreased customer loyalty; and loss of employee morale, among others.
Top FDA Observations for 2011
When the top FDA observations for 2011 are reviewed, one finds that there is nothing extremely technical about the observations. The basics – documentation, SOPs, CAPA, audits, design control, etc. – are still causing regulated industry problems. This leads us to the root of many of these observations:
- Procedures for Corrective and Preventative Action (CAPA) have not been adequately established.
- Written reporting procedures have not been developed / maintained / implemented.
- Complaint handling procedures for receiving / reviewing / evaluating complaints have not been established / defined / documented / completed / implemented.
- CAPA activities and/or results have not been adequately documented.
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
- Quality audits / re-audits have not been performed.
- Procedures for quality audits have not been adequately established.
- Procedures for design control/change have not been established.
Implications for Quality
- Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization.
Robust quality systems are a strategic imperative. In the long-run, companies that consistently deliver high quality products will have an advantage over competitors. Robust quality systems don’t just appear. From the top working down, management with executive responsibility must support quality and compliance, both philosophically and with resources. From the bottom working up, operations and quality must provide management with executive responsibility information to ensure that decisions are data driven.
- Quality has a high cost
- Poor quality has a higher cost
- A compliant quality management system is not always an effective quality management system
- Effective quality management systems:
- Require design, implementation, utilization, continuous improvement
- Require appropriate inputs and outputs
- Provide accurate and relevant information, in a timely fashion, to make data-driven decisions
- If quality is not driven from the top downwards, use QMS to manage upwards
- “Force” management to act by providing them with the data they require to make decisions
- Neil McCullough, VP, Global Quality and Compliance, PPD, Presentation: CAPA in the CTE
Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.
Kamaal Anas has over 17 years of experience in Regulatory Affairs (RA), Quality Assurance (QA) and Product Development for Drugs, Biologics and Medical Devices. Kamaal recently joined Wright Medical Technologies as Vice President of Regulatory Affairs. Prior to joining WMT, Kamaal was Senior Director of Regulatory Affairs and Quality Assurance for the International AIDS Vaccine Initiative (IAVI). At IAVI, he was directly responsible for RA, QA and Pre-Clinical Safety. The scope of his work covered vaccine discovery and development as well as quality oversight of discovery, design and development laboratories, manufacturing and quality control, pre-clinical safety testing, clinical research centers, and safety and immunogenicity testing laboratories. Prior to joining IAVI, Kamaal was the Senior Director of Regulatory Affairs and Quality Assurance for Meridian Life Science, Inc. In this capacity, he helped Meridian expand facilities, increase product offerings, improve quality systems, and collaborated with business development to increase business. Before joining Meridian, Kamaal held positions of increasing responsibility, culminating in Vice President of Technical Operations for Equi-Tox, Inc., a pharmaceutical company developing the drug domperidone for a novel application. He helped Equi-Tox develop domperidone to an advanced state of development leading to its sale to a large pharmaceutical company. He also helped design and construct their manufacturing facilities, develop new products, establish business relationships and start a supporting compounding pharmacy business. Kamaal also provides ad hoc Regulatory Affairs and Quality Assurance consulting services to the drug, biologic and medical device industries. Kamaal can be reached at email@example.com.