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Principle #10 - Conducting Planned and Periodic Audits
Good Manufacturing Practice is a government regulation which establishes minimum standards that prevent your products from being adulterated or misbranded. More important, GMP is the "lifestyle" you live at your company to achieve the three business goals of Company Productivity, Product Quality, and Employee Health and Safety.
Now, how does the government know and how do you know that you are achieving these goals of GMP? The answer is by conducting planned and periodic audits of your job performance. For example, the Food and Drug Administration conducts external audits to evaluate your compliance with the GMP regulation. In addition, your company conducts its own internal audit to evaluate how well you are living a Lifestyle of GMP.
Since everyone is ultimately responsible for GMP in your company, you should personally audit your own job performance every day. Let's review several of the key areas you should be concerned with in conducting your personal audit. The following questions are designed to help you audit your own job performance. By answering each of these questions you can evaluate how well you are living a lifestyle of GMP.
Written Procedures
 | Are there written procedures that provide me with a "blueprint" or "step by step instructions" for performing my job? |
| Do I know and understand these procedures and do I carefully follow them? |
| Do I regularly check my written procedures to make sure they are accurate and up-to-date? |
| When I see an easier or better way to do my job, do I go ahead and deviate from my written procedures or do I discuss the change with my supervisor first? |
Job Competence
| Do I have the necessary education, training, or on-the-job experience to perform my assigned function? |
| Have I identified and learned the "must knows" for my job? For example, do I know and understand the safety standards and regulations that apply to my job? |
| Have I identified and acquired the necessary skills or "must dos" that specifically relate to my job? For example, do I keep accurate records and do I safely operate my equipment? |
| Do I demonstrate my job competence by performing my job right the first time and every time? |
Documentation and Validation
| Do I carefully document my work by recording all necessary information immediately on the batch or history record? |
| When and where a signature is required, do I sign my name legibly and in ink? |
| When the batch or history record requires it, do I mark down the date and the time I started or completed the job? |
| Do I validate my work by checking and double checking all critical operations to make sure there are no mix-ups or errors? |
Sanitation and Cleanliness
| Do I practice good personal hygiene? |
| Do I always wear the proper clothing in the workplace? Do I wear the clothing properly? |
| Do I keep my equipment and tools clean and store them in the proper manner? |
| Do I quickly report any conditions in our plant or with our equipment that could be potential sources of product contamination? |
Maintenance of the Workplace
| Do I have adequate space in my work area to safely and effectively perform my assigned job? |
| Do I minimize the chance of product contamination, mix-ups and errors by helping to control the Internal Environment of the plant? |
| Do I perform routine maintenance on my equipment and do I check to see if my measuring and testing equipment has been properly calibrated? |
| Do I keep accurate equipment logs and do I promptly report any maintenance problems to the supervisor? |
Quality Control
| Do I carefully control the components used in the manufacture of our products? |
| Do I pay close attention to the control numbers assigned to our product components and to the individual lot numbers assigned to our finished products? |
| Do I know and understand what responsibility the Quality Assurance/Quality Control Department has for assuring Product Quality? |
| Do I know and understand my responsibility to build quality into our products? |
If you have answered "yes" to all these personal audit questions, you are probably doing a good job. Congratulations! If your answer is "no" to any of these questions, some corrective action is in order. If you need help correcting a problem, ask your supervisor.
Auditing is an important tool to help you evaluate your progress toward the goals of GMP. The FDA externally audits your compliance with the GMP Regulation and your company's internal audits measure the success of our GMP Lifestyle. But most important, it's your personal responsibility to evaluate how well you are living up to the standards of GMP. Make a personal GMP audit part of your daily work habit today.
