Increase Productivity & Reduce Waste: Integrated Quality Management, Six Sigma & Process Control
Design, development and manufacturing in a risk-based, quality-assured environment are prerequisites of regulatory approval in Life Sciences such as Pharmaceutical, Biotech, Medical Device & Blood Services. With the penalties for non-compliance ever increasing, and given the competitive nature of the global business environment, it becomes essential to reduce cost of compliance and associated resource expenditure, such as due to duplication of effort, audit preparation, and audit follow-up.
The Life Sciences market is now embracing a systematic risk-based approach to regulatory compliance, thereby increasing regulators' confidence and addressing potential product risks. Key regulatory functions include Auditing, Document Control and CA/PA Management. Quality improvement and waste reduction opportunities, identified via audits, feedback from customers or process personnel, and results of process control strategies are promptly identified, prompting Corrective Actions jointly managed by key stakeholder groups. Action items from CAPA, audits and strategic business initiatives are tasked and tracked for optimal efficiency and feedback as Six Sigma process improvement projects. Approvals are seamlessly communicated as necessary throughout the stakeholder groups.
Six Sigma Design & Process Improvement
Coordinated preventative approaches are necessary to meet the competitive regulatory challenges of the next decade. Well-meaning process improvement projects can become stymied by limited resources, a lack of stakeholder buy-in, or a less than thorough implementation process. Strategic business decisions, as well as daily operational issues, are decided without the benefit of data, or with the use of improper analytical tools to correctly understand the nature of the business environment. A properly designed and implemented Six Sigma effort will integrate prioritization and deployment of improvement opportunities and strategic business development issues into the middle to upper levels of management, where they are inherently aligned with the strategic business objectives. The Six Sigma approach for resource allocation, coupled with the DMAIC/DMADV project methodology, builds buy-in within the key stakeholder groups, reducing the time, effort and cost associated with achieving regulatory compliance, business development and business performance improvements.
Process Capability, Validation & Control
Process validation and continuing control are essential components of compliance, including the FDA PAT. Regulated industries recognize the reduced cost and increased efficiencies associated with predictable levels of quality and timeliness, whether in their support processes such as billing and compliance management or the revenue generating processes comprising the core of their business. Statistical Process Control (SPC) provides the means to recognize and achieve greater consistency in fulfilling regulatory requirements. SPC is an essential component of the Six Sigma DMAIC/DMADV project deployment methodologies, providing the baseline estimates of existing processes in the Measure stage (or validation of new processes in the Design stage), as well as the means to control the process or its input in the Control/Verify stage. Whether accessing data via keyboard entry, electronic measurement equipment or LIMS databases, today's SPC software provides rapid yet advanced real-time analysis of process data, including: alerts to online and offline users; customized reporting through Excel, Word templates, or a secure access-controlled web interface for remote management, field operatives or customers; and integration with process documentation and instructions. SPC software is one of the essential tools to maintain an advantage in today's competitive marketplace.