GMP. Makes Good Business Sense. David C. Markovitz

Transcription

1 GMP Makes Good Business Sense A GMP Lifestyle Publication

2 GMP Makes Good Business Sense The price of admission into the food, drug, medical device, blood, biologics, and dietary supplement industries in the United States is a commitment to abide by current Good Manufacturing Practice (cgmp). cgmp is a federal regulation enforced by the U.S. Food and Drug Administation (FDA). Some organizations view this as a curse - an overbearing government imposing a series of strict regulations. While others view this as a blessing, as leverage in order to rally their employees around a set of standards designed to ensure that their business operates in a state of control. Those organizations which have chosen the latter view tend to 1) have a better working relationship with the regulatory agencies, including the FDA, and 2) have more successful and profitable businesses. Sometimes, it s all in one s perspective. 2

3 Does Following GMP Make Good Business Sense? Yes, FDA has simply provided our industries with a framework, a business plan, for building a successful company. It is in our best interest to understand the GMP regulation and Make GMP a Lifestyle in our organizations. At the foundation of the regulation itself is the premise that a business should be operated with systems in place to minimize the chance of contamination, mix-ups, and errors, with the ultimate goal of preventing contamination, mix-ups, and errors altogether. Essentially, GMP states that you should operate your company in a state of control. 3

4 Would You Like to Lower Costs? An organization without contamination, mixups, and errors operates with lower costs than one where rework and re-scheduling predict with a greater degree of accuracy than one that endures some level of contamination, mix-ups, and errors. A company employees. wreak havoc with the organization and the operating in a state of control can plan and Would You Like to Improve Productivity? An organization without scrap and rework rewards itself with higher productivity. Morale among the workforce can only improve with predictable work schedules and work loads. This leads to people taking pride in their work. Would You Like to Improve Profits? It doesn t take an accountant to determine the condition where costs are down and productivity is up. This condition is called making money, profits, and a healthier bottom line. 4

5 How Does GMP Lead to Lower Costs, Improved Productivity, and Higher Profits? Let s start by asking a simple question about your business. What is the aim of your business? Here are some likely answers. To make a profit. To satisfy our customers. To exceed our customers expectations. To solve problems our customers have. To provide jobs. To provide high quality, high value products and services. To expand market share. To develop new products and services. Which of these answers is the right answer? They are all correct. Some answers may be more correct than others based upon your experience and/or personal bias. Let s examine the relationships between these right answers. 5

6 Start With The Customers Although we can start exploring the relationships among these answers with any individual answer, let s choose to start with the customer. After all, without customers, a business does not exist. So, let s say that our aim is to not only satisfy, but to exceed our customers expectations as well as to provide solutions to existing and future problems they may have. 6

7 This leads us to another question. What must we do to ensure that we are exceeding our customers expectations? First, we must know our customers expectations, and understand their wants and needs. We must also know what problems they currently face, or are likely to face in the future. This requires market research - collecting and analyzing data. Then, we must provide our customers with high quality, high value products and services. So, What must we do to ensure that we are exceeding our customers expectations? Provide high quality, high value products and services. A new question then arises. What must we do to ensure that we are consistently providing high quality, high value products and services. Answer: Optimize and improve the methods used to produce those products and services. Examine the systems, processes, and procedures in place. Ensure that these are all operating in a state of control. Predictable systems and GMP Makes Good Business Sense processes yield predictable results. This now leads to the next questions. What does our organization look like when our systems and processes are operating in a state of control? What happens to our organization when our systems and processes are operating consistently day in and day out, hour after hour, yielding the same predictably good results? Rework is down. Scrap is down. Contamination is reduced. Mix-ups and errors are virtually non-existent. Accidents are reduced when people aren t scrambling to make up lost time due to schedule changes resulting from rework and scrap. Overall, trouble is greatly reduced. What happens to operating costs when your systems and processes are operating in a state of control, predictably yielding consistently good results day after day, hour after hour, with contamination, mixups, and errors virtually non-existent? Costs go down. First, we must know our customers expectations, and understand their wants and needs. 7

8 Don t spend time developing a product or service nobody wants or needs. 8 What happens to productivity when costs are down and your systems and processes are yielding near perfect results? Productivity goes up. What do you call the condition when costs are down and productivity is up? All together now, MAKING MONEY!!!!!!!! GREATER PROFITS!!!!!!!! What can we do with this money we ve made? First, provide a Return on Investment (ROI) to the owners. (Shareholders if a public corporation, or owners if privately held.) Shareholders and owners expect a better return on their investment than stashing their money in a bank. So pay them what they deserve. Then, re-invest in the business. Developing new products and services requires money. So does market research. Expanding market share usually requires investment. Training and development for your employees requires an investment. Being a good corporate citizen in your community costs money. How do I spend my money wisely? It comes back to the customer. Don t spend time developing a product or service nobody wants or needs. There are strategic decisions to be made. Planning processes can help here. This completes the GMP Chain Reaction (Figure 1). In the example we ve just drawn, it starts with the customer, and returns to the customer. This GMP Chain Reaction can be viewed as a roadmap to business success. Any business, in any industry, would be served well by following this roadmap. The nine components need to be taken together and viewed as a system. These components must be integrated into one operating system. GMP can provide the glue to keep these components sticking together, ensuring optimal success whereby everybody wins. Owners and shareholders win, customers win, employees win, suppliers win, and the community wins. That s why GMP makes good business sense!

9 The GMP Improved Profitability ROI Stay in Business, Expand Marketshare, Invest in R&D, Provide Jobs Market Research Exceed Customers Expectations Chain Reaction Increased Productivity Successful Businesses Provide High Quality, High Value Products and Services Reduced Costs (Fig. 1) Reduce Rework, Scrap, Mix-ups, Errors & Contamination Optimize and Improve the Systems, Processes and Procedures GMP Makes Good Business Sense 9

10 Looking Exceed Customers Expectations Optimize and Improve the Systems, Processes and Procedures Provide High Quality, High Value Products and Services Back The GMP Chain Reaction can be divided into two sides - the left side and the right side. In looking back over the last fifty years or so, American industry has focused most attention on the left side of the GMP Chain Reaction. Many companies have conducted profit improvement programs, productivity improvement programs, and cost reduction programs. American industry has become very adept at managing this side of the GMP Chain Reaction. It s only been since the late 1980 s that industry has begun to focus on the right side of the GMP Chain Reaction as well. Lean manufacturing and six sigma programs have been implemented. Some organizations have swung their focus totally towards the right side, ignoring the left side, and have run into trouble. The focus must be on the entire GMP Chain Reaction as a system. Imagine higher quality at reduced costs. Possible? Yes, by optimizing and improving the systems and processes used to produce those products or services. Achieving higher quality by inspection and sorting, a traditional method employed when focused on the left side, results in increased costs. Those organizations with their eye on thriving in the future will view the GMP Chain Reaction as an integrated system. And they will deliberately and proactively manage and optimize that system. They will provide their people with the knowledge and skills required to manage their work systems and processes as well as the interfaces where two or more work processes come together. They will ensure that all parts work well together. 10

11 Fueling the Chain Reaction There are two key components which fuel this Chain Reaction. These two components were identified by the FDA in 1968 in their GMP training film, No Margin for Error. Two major problems identified in this film were Poor Planning and Faulty Procedures. Planning is addressed in the middle circle at the top of the GMP Chain Reaction (Figure 1). Plans on where to invest resources need to be focused on what will please the customer. Planning is the domain of management. This often determines whether an organization can stay in business, not just keeping up with customer demands, but leading their customers into the future. The medical device industry has countless examples of new and innovative solutions to age old problems. GMP Makes Good Business Sense Faulty Procedures (a 1968 term) is addressed by the box in the lower right corner of the GMP Chain Reaction (Figure 1). This component is the domain of every single person in the organization. Everyone is working in a process. Everyone is using procedures, written or not. This is the area emphasized in both the ISO standards and the GMP regulation. Managing systems, processes, and procedures is the key to yielding consistent results. Most organizations monitor and measure results. The number of shipments, value of shipments, and number of transactions are a few examples. Few organizations monitor and measure their processes and process variables, and then actually use the data to make adjustments and improvements to those processes. 11

12 Manage the Process Managing processes is the real opportunity to prevent contamination, mix-ups, and errors and ensure that your business is operating in a state of control. The focus should be on Prevention - preventing problems from occurring. The FDA has given us the acronym CAPA, meaning Corrective and Preventive Action. Corrective Action is solving problems. Preventive Action is preventing those problems from occurring in the first place. A better way to express this is capa with the emphasis on Preventive Action. However, many organizations and individuals pride themselves on their problem-solving prowess the ca in the acronym capa. They wait for problems to occur, then spring into action, sometimes performing heroic tasks to solve the problem, while operating in a crisis mode. The drama associated with dealing with a crisis can cause the adrenaline to flow. Our research of over three decades of working with manufacturing organizations in the food, drug, medical device, blood, biologics, and dietary supplement industries has clearly shown that certain types of people are attracted to work in these environments. We characterize these people as action-oriented people. They tend to thrive on the action, and the drama created when things don t go according to plan. The superhuman efforts required to get us out of this mess create great satisfaction for some individuals. They thrive on the attention, taking great fulfillment that they are important. They also know that they will be called upon again when this same problem resurfaces, which inevitably it will, if no one is working to improve and optimize the systems and processes associated with that particular event. 12

13 the Paradox Herein IS the Paradox. When efforts are focused on optimizing and improving the systems, processes, and procedures used to manufacture the high quality, high value products or produce the high quality, high value services, the problems begin to become fewer in number. Things start operating in a state of control - with fewer and fewer problems occurring. How, then, are these adrenaline junkies (the problem fixers ) going to get their fix? The actions required to optimize and improve systems and processes the PA in the acronym capa - are normally not done during a crisis. They are the results of ongoing efforts usually by teams of people working together to identify causes of variation and brainstorming possible solutions, then GMP Makes Good Business Sense trying these solutions under controlled conditions. There is little drama here, only patience, perseverance, and hard work. The challenge is in redirecting the energy of our talented workers into optimization activities. There are significant gains to be made in designing systems and processes that will yield consistently good results. There are significant gains to be made in creating procedures based upon the current best method which are understandable and usable by those charged with using them. Optimization means making things the best that they can be. Ensuring that all components, all departments, are working together to produce the very best result, just as the sections of a symphony orchestra work together to produce good music. 13

14 the Frame work We have developed a Framework for integrating the GMP regulations with quality management standards. This Framework provides guidance in deploying the energy and resources to bring any organization into a state of control. Essentially the Framework is a vehicle for making GMP a Lifestyle in your organization. The Framework consists of seven sections: General Controls Design Control Facility Control Equipment Control Material/Component Control Operational Control Finished Product Control 14

15 Each section contains several specific categories which outline the systems and processes relevant to that section. 1. General Controls Organizational and management responsibilities Document control system Employee orientation, quality awareness and job training systems Plant safety and security systems Internal quality/gmp audit systems Quality Cost program 2. Design Control Product design and specification control systems Production process design control systems Quality assurance design and specification control systems Design validation systems Design change control systems 3. Facility Control Facility design and layout Environmental control systems Facility maintenance and good housekeeping systems Outside contractor control system 15

16 sampling, and laboratory testing systems Material/Component storage and handling systems Inventory control program Vendor/Supplier control program Equipment Control Equipment design and placement Equipment identification and log books Equipment maintenance program Measurement equipment calibration program Equipment qualification program 5. Material/Equipment Control Material/Component specification and purchasing control systems Material/component receipt, inspection, 6. Operational Control Material/Component/Label verification, storage, and handling systems Equipment/Line/Area clearing, preparation, and clearance systems Operational process validation and production change order control systems In-process inspection, sampling, and laboratory control systems Reprocessing/Disposition of material systems 7. Finished Product Control Finished product verification, storage, and handling systems finished product inspection, sampling, testing, and release for distribution systems Distribution controls Marketing controls Complaint handling and customer satisfaction systems

17 Making GMP a Lifestyle The Framework outlined above represents a comprehensive approach towards making GMP work for you. Each component of the GMP Regulation can be traced back into the Framework. Deploying your people into designing consistent processes and procedures for each of the systems outlined in the Framework should provide them with the challenge as well as the satisfaction in knowing that they are creating systems designed to: Meet or exceed customers expectations. Produce high quality, high value products and services. Reduce the chance of contamination, mix-ups, and errors. Reduce costs. Increase productivity. Improve profitability. Increase market share, thus providing opportunities for advancement and new jobs in the future. And many more benefits. GMP, applied correctly, can bring financial rewards as well as the rewarding experience of designing and managing systems operating in a state of control. This controlled environment is the leverage towards providing your customers with consistently high quality products and services. Indeed, GMP does make Good Business Sense! 17

18 GMP Training Systems, Inc. is a leading edge, top tier provider of compliance products and services. Our aim is to help you make GMP a Lifestyle in your organization. GMP Training Systems We do this by providing: GMP Boot Camps open enrollment workshops conducted throughout the year in multiple locations. In-plant training we design and conduct training specifically to meet your needs at your location. Let Our Experts be Your Experts! Web seminars Regularly scheduled web seminars with leading industry experts. GMP Training Products Our GMP Training System is available in three formats and in English and Spanish. Instructor-led format for you to use in classroom training. Interactive Computer-based format where you set up a workstation for your people. Web-based format where your people access the training using the Internet. FDA Survival Kits Products to help you stay compliant on specific topics. Breaking News Our blog, /GMPtips, helps you stay abreast of industry trends. Learn more 18

19 About the Author is the Founder and President of GMP Training Systems, Inc., an education, training, and consulting firm whose mission is to help organizations make Good Manufacturing Practice a Lifestyle, and not just a regulation. Specializing in those industries regulated by the Food and Drug Administration, David has over three decades of practical experience working in the industry and as a consultant helping hundreds of companies become and remain compliant. David is the author of Becoming the Best: Making Optimization Happen, and 212 Tips to Improve Performance, Productivity, and Profits. He is the host and moderator of FDA-focused web seminars and the creator of the GMP Training System, a GMP training toolkit for companies to use to meet federal GMP training requirements. Invite David to speak at your next event or to conduct a workshop for your company, please contact him at David@GMPTrainingSystems.com Subscribe to our popular GMP Tips blog at: /GMPtips Copyright Info 2009 GMP Training Systems, Inc. Copyright holder has licensed this under the Creative Commons License, Attribution 3.0 What You Can Do You are given the unlimited right to print this ebook and to distribute it electronically (via , your website, or any other means). You may not alter this ebook in any way, though, and you may not charge for it. Send This: Pass along a copy of this ebook to others. 19