GMP Training Systems, Inc. Creators of the GMP Ready-to-Use Training System Good Written Procedures = Compliance David C. Markovitz President, GMP Training Systems, Inc. Good written procedures are a key element in successful organizations. Preparing good written procedures is critical for compliance and ultimately in avoiding FDA inspection observations -- which greatly benefits the individual, the organization, and the company. In reviewing FDA 483 Observation Reports and Warning Letters over the years, one thing stands out -- People do not do what they are supposed to do they do not follow written procedures. We have addressed this issue in our training workshops for many years. Attendees have suggested several reasons for this problem. The following are some of the most common reasons given for people not following written procedures. They did not know a written procedure existed. They were not trained in the written procedure. They did not understand the written procedure. They could not find the written procedure. The written procedure was too long. If it takes longer to read the procedure than to do the procedure, problems occur. They thought they remembered how to do the procedure, hence they didn t read it. They found a better way to do the procedure, and applied the better way. They were told to skip the written procedure and go from memory, or just figure it out. The written procedure was poorly written and hard to follow. Most of the above reasons relate to the quality of the writing of the procedures. Writing good procedures is a vital key to eliminating almost all of the above problems. The following discussion will address the reasons people do not follow procedures. We then discuss the characteristics, Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 1
preparation, and implementation of well-written procedures procedures that people will follow. ADDRESSING THE PROBLEMS Dealing with the issues described above is not difficult. It requires the discipline to address each of these in detail. Further, there must be a quality system or process in place to manage corrective actions. A system to maintain these good practices should be established and continually maintained. The following are suggested solutions for the problems identified above and how to successfully manage these issues. Employees Did Not Know a Written Procedure Existed Ensure that each person has a list or roster of those written procedures that they are responsible for understanding and following. Supervisors should be responsible for ensuring that their people know what written procedures apply to their jobs and that they are trained and understand each of those procedures. A job certification process can help ensure that people are familiar with the written procedures that impact their work. Employees Not Trained in the Written Procedure Maintain accurate training records and generate timely reports to ensure that everyone who is required to be trained in a certain written procedure has successfully completed the training. Employees Did Not Understand the Written Procedure After being trained in a procedure, a person should be able to demonstrate that they understand it and know how to properly implement it. This is best done one-on-one with a supervisor or trainer, and should be documented. Employees Could Not Find the Written Procedure Ensure that applicable written procedures are accessible at or near where the work gets done. Ensure that everyone knows where the specific locations of written procedures are that apply to their work. The Written Procedure was too Long. If it Takes Longer to Read the Procedure than to do the Procedure, Problems can Occur Write crisp and concise written procedures. An effective written procedure takes into account what the operator should already know about the process and not have too many details in the written procedure. Too Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 2
much detail is just as bad as not enough detail in a written procedure. Work to attain the Right Dose of detail in preparing your written procedures. Employees Thought They Remembered How to do the Procedure -- So They did not Read it This requires constant reminding that following the written procedures is critical for success. This also requires the discipline to adhere to quality standards as well as effective leadership and management. Employees Found a Better Way to do the Procedure, and Applied the Better Way It is not unusual for those doing the job to discover better ways to do that job. But in a GXP environment, changes must be evaluated and approved. Then the written procedure must be updated and everyone who uses it must be trained in the revised written procedure. Everyone should be aware of and familiar with your Change Control system, and how to use it. Employees Were Told to Skip the Written Procedure and Go from Memory, or Just Figure it out This is a leadership and management issue. Ensure that your managers and supervisors are practicing GXP compliance and setting the right example all the time. Written Procedure Was Poorly Written, and Hard to Follow. Prepare good written procedures. WHAT IS A GOOD WRITTEN PROCEDURE? A good written procedure is one that works and is easy to follow. A good written procedure is one that has the following characteristics: Clear -- Understood by everyone who works with it Concise -- Contains the right dose of detail Follows a standardized format Contains graphics and/or pictures where appropriate Has a logical flow - a step-by-step approach Clear Understood by Everyone Who Works With the Procedures Consider the people in your workforce who use the written procedures. Some questions to consider are: What is their educational background? Do you have people with advanced degrees in one of the sciences? Are you writing procedures for people who haven t taken a science Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 3
class in high school, and graduated from high school twenty years ago? Be sure to address any education gaps that may exist in your organization. What are their language skills? How many people in your workforce speak more than one language? This is critical where their primary language is different from the language in which your procedures are written. Be sure to address any language gaps that may exist in your organization. Do your written procedures contain unique words and/or phrases or company jargon? Do they contain acronyms and/or abbreviations? How do new people learn the unique words, phrases, acronyms, abbreviations, and company terminology or expressions? A company Glossary of Terms that new people receive upon joining the company is useful. Concise - Contains the Right Dose of Detail Ensuring the Right Dose of detail can help avoid written procedures from becoming too long or being too short. Determining what you cover in training versus what details you put in the actual written procedure is a key consideration. Standardized Format Your organization should have a standardized format to which each written procedure should adhere. Graphics and/or Pictures Where Appropriate There is an old adage: A picture is worth a thousand words. Adding graphics like flow charts, diagrams, and pictures can help clarify as well as shorten a written procedure. In the past we didn t incorporate many graphics, diagrams, or pictures because it was hard to do, time consuming, and expensive. Modern technology has made adding a graphic as easy as a click or two from a digital camera or smartphone. Graphics, diagrams, and pictures are helpful in showing how to clean a piece of equipment, or set-up or disassemble a piece of equipment. The possibilities are endless in finding applications where graphics, diagrams, and pictures can help the written procedure become easier to understand and follow. Many people, if not most people, are visual learners. We learn with our eyes. So adding visuals to your written procedures helps make them better procedures. Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 4
Logical Flow A Step-by- Step Approach Think of some of the instructions you may have encountered with things you have bought as a consumer. Trying to follow those procedures sometimes leads to frustration and angst. We often wonder Who wrote this procedure or instruction manual and what were they thinking? A good example of well developed instructions using a logical flow comes from Lego building blocks. In fact, Lego building blocks not only follow a logical step-by-step approach, they consist of all pictures. Another good example is furniture from IKEA. Most furniture available from IKEA must be assembled, and their instructions follow a step-bystep approach and are mostly pictures. They even include the tool you need for assembly. Ensure that the written procedures you develop have a logical flow and follow a stepby-step approach. PREPARING EFFECTIVE WRITTEN PROCEDURES We have found that the optimal way to ensure that we write good procedures is to involve and include the right people in their preparation. Who are these right people, and how should new procedures be implemented? Team Approach Writing a good procedure is requires a team approach. The appropriate Subject Matter Experts (SME) and two or more users of the procedure should work together to develop the procedure. Writing a procedure by committee takes longer than by a single individual in an office. However, there are some important tangible benefits gained from this approach. Some of these benefits include: The users of the procedure may point out details that the SME may have overlooked. The SME can help the users better understand the aim of the procedure and some of the nuances of implementing and following that procedure. The users can help identify the possibilities of what might go wrong during the implementation of the procedure. An enhanced relationship between the SME and the users develops. When issues arise during production, it becomes easier and often quicker to access the SME for help or advice. The users often begin referring to the written procedures as our Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 5
procedures rather than the procedures or their procedures. Our procedures brings with it ownership, and increases the probability of those procedures being followed all the time. Conduct a Pilot or Trial Run before Implementation It is always a good idea to try a new or revised written procedure on a small scale before final implementation. Ensure that all the users as well as the SME are present for this test or trail run. It is not unusual to discover unanticipated details during the test run that should be addressed in the procedure. FINAL THOUGHTS Preparing and following good written procedures is a major key in compliance and ultimately in avoiding FDA inspection observations. This is good for the individual, the organization, and the company for many reasons. Regulatory observations are an embarrassment that reflect poorly on everyone. Avoiding observations saves money. Responding to an FDA 483 Observation Report or Warning Letter takes resources, time, and money. Also, stress is avoided by not having to deal with corrective actions and FDA imposed deadlines. Having and following good written procedures also leads to less rework, less scrap, reduced costs, and higher profits all of which are good for the company. David Markovitz is the Founder and President of GMP Training Systems, Inc., (www.gmptrainingsystems.com) a top tier provider of GMP training products and services. David can be reached at David@gmptrainingsystems.com and at 714-289-1233. Get a copy of our ebook, GMP Makes Good Business Sense. It s free, go to www.gmptrainingsystems.com and click on Free ebook. Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 6
GMP Training Systems, Inc. Creators of the GMP Ready-to-Use Training System Three Key Considerations in Developing Written Procedures that Work David C. Markovitz President, GMP Training Systems, Inc. Developing written procedures that are effective and understood by everyone in an organization is not an easy task. Many written procedures are done in a hurry to meet deadlines or are cranked out by people who have little or no training in writing good procedures. There are three key considerations to take into account when preparing written procedures. This article will present these considerations as potential gaps in the process. By addressing these gaps before you embark on developing written procedures, one improves the likelihood that your written procedures will be effective. Education Gap It is not unusual to turn to Subject Matter Experts (SMEs) to prepare written procedures. In some instances the SME may have advanced education and experience in the system or process. One example we ve seen is a Scientist or Engineer with an advanced degree writing a procedure that will be used by someone who didn t even take science in high school (and completed high school 22 years ago). This can lead to an understanding gap. If the Operator does not understand the written procedure, then the Operator faces a dilemma. 1) The Operator can go to their Supervisor for help. 2) The Operator can turn to their co-workers for help. 3) The Operator can attempt to contact the SME who prepared the written procedure for help, or even attempt to contact those who approved the written procedure. 4) The Operator can guess what is meant and proceed. Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 1
5) Stop. Remember that Operators are usually working to deadlines in a Production environment. There is little time afforded to choose the right path forward. What is the Operator to do if they cannot find the Supervisor? What if the co-workers cannot provide any help? What if the SME and/or approvers are not available? Too often the Operator has only Option #4 to choose from guess and proceed. In the GMP (Good Manufacturing Practice) regulated companies, this is known as LMP Lucky Manufacturing Practice! Many times the operator gets lucky and guesses right, usually based upon experience or memory. But every once in a while, the Operator will guess wrong, and a problem occurs. In some companies Option #5 Stop is expected and acceptable behavior. However, in many companies someone stopping a process in a production area is frowned upon or discouraged. Sometimes the discouragement is done in subtle ways. Remedy for the Education Gap GOOD - Ensure that those who will be implementing and using the written procedures understand those procedures before starting the process. Effective training in each written procedure is part of the answer. And the key is EFFECTIVE TRAINING. Reading a procedure and signing a form saying that one has read and understands the procedure is usually NOT effective training for most people. Effective training should be conducted in a non-threatening manner where people are encouraged to ask questions and demonstrate that they understand and can follow the procedure under consideration. BETTER - Involve the people who will be implementing and using the written procedures to review the procedure BEFORE the procedure is approved for use. Facilitate a method for feedback in improving or revising the procedure under consideration based upon feedback from the operators/users. BEST - Involve the people who will be implementing and using the written procedures to participate in developing the Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 2
procedure. Have one or more of the Operators work with the SMEs to develop the written procedure. Yes, this will take longer. But the end result will be a procedure that is better understood by the Operators, thus eliminating Lucky Manufacturing Practice from your company. You also get ownership of those procedures by those responsible for implementing them. The operators often refer to those procedures as OUR procedures, not THE procedures or THEIR procedures when they have participated in developing them. Once a draft of a written procedure is completed, it may be useful to use a readability index to determine the comprehension level/readability of the document. There are several indices available on the Internet. Microsoft Word also has a readability function. Language Gap In the United States, many companies employ people whose primary language is not English. Thus, there is wide variation among the fluency in the English language among employees in many companies. This language gap can present a serious problem if some people cannot read and/or understand the written procedures. This is a growing problem facing industry in almost all regions of the United States. Remedy for the Language Gap Implement an assessment before hiring people for positions where reading and understanding your written procedures is critical. Check with your Human Resources department on what assessment may be appropriate and what governmental guidelines and regulations exist before implementing any language assessment. If you already have people working at your company where English fluency is a problem, then you can help them improve their English language skills. Community colleges are a valuable resource for English as a Second Language (ESL) courses. Many companies have contracted with local community colleges to conduct ESL courses for their employees in order to improve the English fluency of their workforce. You can work with the community college staff to design an appropriate assessment of your employees and design an appropriate course of action. A post assessment can be designed to Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 3
determine whether the desired fluency level has been attained. Community colleges are generally easy to work with and affordable. Generation Gap Consider those now entering the workplace for the first time. The generation now entering the workplace this year s college graduates were born in 1991 or 1992. This year s high school graduates were born in 1995 or 1996. Think about their life experiences. They are the digital generation. They don t remember life before computers. They have never seen a floppy disk. They have only seen a typewriter in a museum. They don t remember life before cell phones. They don t remember life before e-mail or texting. They use text messaging more than e-mail. They use their phones to text message, not to make calls. They don t remember life before the Internet. They don t remember telephone modems, and the slow speeds of browsing the World Wide Web with a telephone modem. They don t remember the Soviet Union or the fall of the Berlin Wall. They don t remember the gulf war in 1991 - Desert Storm. To them it is in the same category as the Vietnam and Korean wars history lessons. They don t remember cassette tapes or records. They have only seen a record player, hi-fi, or stereo in a museum (or at their grandparent s house). They have never been to a music store to buy music, except perhaps when they were toddlers and were with their parents. They don t (or barely) remember VCRs and VHS tapes. They don t remember when MTV only played music videos. They ve never been to a drive-in movie. Tweet is something we do, not birds. Spam is unwanted emails, not processed meat in a can. Clockwise or counter clockwise may have no meaning they grew up with digital clocks. If you mention President Bush, they don t say Which one? They don t remember George H.W. Bush, President from 1989 Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 4
to 1993. They only know George W. Bush, President from 2001 to 2009. If you mention the name Clinton, they think of Hillary before they think of Bill. If they hear the word Beatles/beetles, they think of insects, and not of John, Paul, George, and Ringo. If they hear the word mouse, they think of computers before they think of rodents. And here s the big one. This generation created their own language. It s called text messaging. It was created by young people throughout the world. They use no capital letters. No punctuation. Abbreviations galore. Acronyms many people have never heard of. And no governing body to determine rules for the application of this new language. Now we hire these young people and ask them to write Standard Operating Procedures. OMG! LOL! Remedy for the Generation Gap An effective and powerful employee orientation process for integrating new people into the company is paramount in developing an effective workforce. One important objective of a new employee orientation process is to help a new employee feel welcome and that by joining the company they will be a part of something important. An effective orientation process conveys the importance of each job in the company and helps people see that they will be making meaningful contributions to society, and not just having a job. There are several critical points to cover in an effective orientation process. Here are some important points that should be included. History of the company Most companies have an interesting story surrounding how the company was established. Make sure that everyone knows this story. Products and/or services Make sure that new employees know and understand what your products and/or services are, how they are used, why they are used, and who uses them. Customers Make sure that new employees know and understand the company s customers and the impact that a Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 5
defective product or service might have on the customer. The Big Picture: How work gets done in the company Make sure that new employees see how a product gets made or how a service is provided. Flow charts are helpful here. Help new people see where they will be fitting into the Big Picture. Knowing who their internal customers and suppliers are helps optimize communication throughout an organization. The Role of the FDA and other Regulatory Bodies Make sure that new employees know and understand that your company is regulated by the US FDA and/or other appropriate governmental agencies. This knowledge lays the groundwork for why company policies and procedures must be followed. GMP Compliance This is where new employees should get their initial dose of GMP training. Make sure that new employees know and understand the importance of following GMP, and the consequences to them and to the company of non-compliance. Your Company Policies and Procedures Make sure that new employees know and understand that following your company policies and procedures is an important aspect of GMP compliance. Conclusion There are several factors that contribute to developing effective written procedures. Addressing these three gaps will go a long way in ensuring that the written procedures you develop will work to help you become more compliant. Having written procedures that are clearly understood by everyone makes them easier to follow, which in turn leads to less rework, and results in lower costs and higher profits. David Markovitz is the Founder and President of GMP Training Systems, Inc., (www.gmptrainingsystems.com) a top tier provider of GMP training products and services. David can be reached at David@gmptrainingsystems.com and at 714-289-1233. Get a copy of our ebook, GMP Makes Good Business Sense. It s free, go to www.gmptrainingsystems.com and click on Free ebook. Copyright GMP Training Systems, Inc. ALL RIGHTS RESERVED 6
Creators of the GMP Ready-to-Use Training System GMP Training Systems, Inc. is an education, training, and consulting firm whose mission is to help organizations improve their productivity, quality, and long-term profitability by implementing strategies focused on innovation, continual improvement and optimization of work systems and processes throughout all levels in an organization. We translate GMP and compliance issues into plain and simple language that people at all levels in organizations can understand and implement. We help our clients through: Customized in-plant training on compliance, management, and performance enhancement topics. Consulting on FDA compliance issues and development of world-class training systems and processes. Public workshops regularly scheduled at different locations. Web seminars scheduled weekly where we bring leading industry experts into your plant via teleconference and the Internet. GMP Training Products Our unique GMP Training System is available in three formats: For use by your internal trainers, supervisors, and leads to conduct classroom training, Interactive Computer-based platform for individuals and Web-based platform. Available in both English and Spanish versions. GMP Compliance Resources Web-based GMP resource library. Keynote presentations Energize your next meeting with a world-class award-winning speaker listed in the Who s Who of Professional Speaking. Complimentary GMP electronic newsletter to keep up to date on current issues www.gmptrainingsystems.com/gmptips P.O. Box 2585 Orange, CA 92859 714-289-1233 Fax: 714-289-0190 info@gmptrainingsystems.com www.gmptrainingsystems.com GMP Implementation Tips blog: www.gmptrainingsystems.com/gmptips
Creators of the GMP Ready-to-Use Training System David Markovitz Founder and President, GMP Training Systems, Inc. David Markovitz has over three decades of leadership and management experience in the health care industry. Having held positions as Manufacturing Laboratory Manager, Packaging and Filling Manager, Pilot Plant Manager, Manufacturing Engineer, Technical Training Manager, and Corporate Director of Education and Training, he has hands-on experience in effectively managing complexity with limited resources. David s corporate experience was acquired at Nutrilite Products, SmithKline Beckman, Organon Diagnostics, and Ortho Diagnostics. David is the President of GMP Training Systems, an education, training, and consulting firm whose mission is to help organizations improve their productivity, quality, and long-term profitability by implementing strategies focused on innovation, continual improvement and optimization of work systems and processes throughout all levels in an organization. David is: The creator of the popular GMP Ready-to-Use Training System. The author and/or co-author of Becoming the Best: Making Optimization Happen, GMP Makes Good Business Sense, The Team Process Improvement Workbook, Innovation Resource Handbook: A Practical Blueprint for Leaders in Industry, Government, and Education, 212 Optimization Tips to Improve Performance, Productivity, and Profits, and Essential Tips for a Successful Speech. The author of the GXP Training Tips column for the Journal of GXP Compliance. The creator, host and moderator of FDA-focused web seminars. A Member of the Editorial Advisory Board of the Journal of GXP Compliance. An internationally recognized and award-winning speaker and workshop leader. President of the Los Angeles chapter of the National Speakers Association (2003-04), the world s leading society for experts who speak professionally. Listed in the Who s Who of Professional Speaking. David had the rare privilege of assisting Dr. W. Edwards Deming, the 20 th century s leading quality guru, in several of his famed Four-Day Seminars. David created and led the Deming Roundtable, an intensive year-long cooperative effort involving eight different organizations working to implement Deming s teachings. An internationally recognized and award winning speaker and workshop leader, David has been invited to present at conferences and meetings throughout the world. He is the recipient of the Gold Microphone Award (National Speakers Association) and the 2004 winner of the prestigious Connie Award for Professionalism on the Speaking Platform. P.O. Box 2585 Orange, CA 92859 714-289-1233 Fax: 714-289-0190 info@gmptrainingsystems.com www.gmptrainingsystems.com GMP Implementation Tips blog: www.gmptrainingsystems.com/gmptips
GMP Products GMP Training System Instructor-led system Computer-based system Web-based system GMP Training System Ready-to-Use Lessons GMP Training Systems, Inc. P.O. Box 2585 Orange, CA 92859 Phone: 714-289-1233 Fax: 714-289-0190 info@gmptrainingsystems.com GMP on-site training specialists We come to your site - Customized training FDA and GMP Survival Kits Be prepared for the FDA Resource Library Extensive electronic resource library E-books and Blog Sign up for current updates www.gmptrainingsystems.com GMP and Validation workshops Conducted on east and west coasts GMP and Validation web seminars Conducted weekly with industry experts www.gmptrainingsystems.com 714-289-1233 Orange, CA