Slim down with lean quality

By Nikki Willett, VP Marketing & Regulatory Affairs, Pilgrim Software, Inc.

During these turbulent economic times, everybody is talking about slimming down and becoming lean. The top 16 pharmaceutical manufacturers spent over $90 billion to manufacture drugs* but half is considered wasted money and an estimated 95% of activities in any pharmaceutical plant fail to add value to the product.

However, inefficiency and deviations causing one minute of downtime can cost a manufacturer over $22,000.** Continuous improvement programs taking aim at overly long cycle times, variability and waste may be doing so in a "silo mentality" preventing manufacturing functions in many companies from seeing the "big picture." Companies that are implementing lean manufacturing programs to improve performance and reduce costs may be incapable without predictable processes built through effective quality management, thereby preventing many lean goals from being met. Untapped potential of quality process automation, which may only account for only 5-8% of total plant costs, can still have an enormous impact on efficiency and quality.

Whether you're complying with national and global quality regulations and guidelines (FDA GMP, EMEA, ISO 9000, ICH Q10, etc.) or simply responding to consumer brand satisfaction, cutting corners with your quality systems and processes is not the answer. 

So what is the answer? How can you get to "Lean Quality?" You need to continually analyze (not guess at or assume) Who does What, When, Where, Why, and How? If these aren't understood, then the process isn't understood, and the ability to control the process will never happen. Where do you need to start? Time? Resources? Processes? Systems? First – Seek and Destroy. Second – Focus on the Fundamentals. Third – Empower with Integrated Technology.

Plan. Start with a simple checklist for planning operational improvements:

• Define: What problem needs to be solved?
• Measure: What is the capability of the process?
• Analyze: When and where do defects occur?
• Improve: How can process capability be improved? What are the final factors?
• Control: What control can be put in place to sustain the gain?

Seek and Destroy. First look at your process efficiency villains. Where are the constraints or bottlenecks within your organization and process? Do you have variations from one area to another? Are there unnecessary steps that can be eliminated? Start by creating process flow diagrams that clearly indicate start/stop points while breaking your steps down consistently. Keep the flow moving downstream while avoiding crossing flow intersections. Keep your procedures simple and intuitive. How much fat (inefficiencies) can you remove?

Focus on the Fundamentals. To go lean, people must become more and more productive over time. Lean quality can be achieved when we learn to associate efficiency with effectiveness. Start by determining "best practices" to optimize your processes and engage the most efficient use of resources. Empower an effective workforce with the right skills, knowledge and decision-making capabilities. Deploy the capability to measure performance and calculate the value through the right metrics. Finally, understand what controls can be put in place to sustain the gain.

Empower with Integrated Technology. Current manual processes can limit the integration of applications and data for adequate analysis to effectively understand your state of quality and potential quality risks. An integrated quality approach needs to be embedded into the core business. Ask yourself how many systems contain some quality data throughout the product lifecycle, from design to services? PLM? ERP? MES? CRM? Other databases and spreadsheets? How much time is spent navigating the maze of quality data versus using and focusing on problem solving? Although these systems provide automation that helps organizations reap the benefits of repeatability and sustainability, are they truly complementing your overall quality investments? A comprehensive quality management system helps companies understand the significant impact that poor quality, service and delivery has on sales and profits. Take what you've learned from your process inefficiencies, and your understanding of best practices, and architect them into an integrated quality platform across your organization value chain.

Re-engineering the Quality System will allow you to get rid of all the waste and inefficiency in the system:

• An effective CAPA system at its inner core, and Document (Change) Control in the outer core
• Prohibit incessant document propagation
• An effective & high-throughput change control system
• Effective (critical) control points and metrics

For lean to work, the quality system must be an integral part of the overall lean process. By identifying and eliminating non-value added steps, thereby eliminating waste throughout the production cycle, companies can convert Quality from cost-absorbing to value-added. Incorporating quality & compliance into a continuous improvement and lean strategy will help companies:

• increase process capabilities and process control
• decrease process variability and reduce production & release cycle time
• actively address and manage risk and compliance obligations
• improve visibility across the organization at ALL levels
• have better accountability and information delivered more quickly.

Lean quality needs to be deeply embedded for lean manufacturing to live up to its promises of lower cost, more efficient processes, higher profits and increased customer satisfaction. Seek and destroy the fat. Exercise your efficiencies. And empower yourself with new lean fundamentals. You won't achieve LEAN overnight. The path to LEAN is NOT a "big-bang," it is incremental, evolutionary and continuous. It requires bottom-up dedication and top-down support, but offers significant return on investment for managers with vision.  

• Standardized Processes – Now!
• Automate Processes – Now!
• Break Barriers – Now!
• Kill Gridlock – Now!

Remember, even a small change in efficiency could save you money. Are you ready? Can you afford not to be?

Learn more about how Pilgrim Software's collaborative quality and compliance management platform enables multiple sites, organizations, customers, suppliers and systems to effectively coordinate improvement activities and share critical quality information to gain and sustain Lean Quality. Go to: www.pilgrimsoftware.com.

* Wall Street Journal
** Nielsen Research 101 Top Manufacturing Executives

Nikki Willet, Vice President of Marketing & Regulatory Affairs, Pilgrim Software, Inc.
As VP of Marketing & Regulatory Affairs, Nikki is responsible for managing all aspects of Pilgrim's worldwide product, industry, regulatory and corporate marketing initiatives. She is a seasoned professional with an extensive background in high tech marketing, technology and regulatory industries. With over 25 years in software, Nikki has focused on advancing technology through the constant evaluation of business trends to help organizations progress and succeed through the use of automation. She has participated in standard committees for the creation of digital standards with the FDA for new drug application (NDA) submissions and for the Air Transport Association (ATA). She is an active member of leading trade and industry associations such as Advamed, as well as RAPS, PDA, ISBT, ISPE, ASQ and AABB representing the industries Pilgrim services. She currently acts as Pilgrim's spokesperson and educator concerning quality, safety, risk and compliance at leading trade conferences, seminars, and universities and has published many industry articles. She founded and is the Group Owner of LinkedIn's Quality & Regulatory Network Group, having more than 7,000 members, to help professionals in sharing ideas and best practices in quality, regulatory, safety, health, sustainability, lean, security, risk and compliance. Ms. Willett holds a BS in Computer Science.