Dont Treat Your FDA Inspection Like an ISO Audit. In the books, the current Good Manufacturing PracticesQS Regulation and ISO 1. The newest version of ISO 1. CFR, Part 8. 20 that it is almost uncanny. Despite the marked similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience of a U. S. FDA inspection very different than an ISO 1. First, lets make sure that we are on the same page this article is about specifically trained people, evaluative approach, regulation vs. Despite the marked similarities between Good Manufacturing PracticesQS Regulation and ISO 134852016, it is the interpretation and the approach of the investigator. PROCESS APPROACH. ISO 9001 2015 section 0. 3 expects organizations to adopt a process approach and section 5. 1. 1 asks top management to exercise. Whats so funny about ISO 9000 Why not have some fun along the way to ISO 9001 certification Here are a few jokes about the process. Please send your original joke. FDA inspects the Quality System using investigators, and ISO registrars conduct audits using auditors. Inspections and audits are 1. Investigators and auditors not only behave differently when they sit across the table from you, but they have a diverse modus operandi that enforces the law and complies with a voluntary standard, respectively. When your company sells medical devices in the U. S., it is mandatory that FDA enforce the law Food, Drug and Cosmetic Act using the QS Regulations to judge your manufacturing and design operations. The ISO 1. 34. 85 Standard is totally voluntary and, frankly, if your company doesnt like the way that it is audited or the auditor that it chose, you can change auditors or, for that matter, change registrars rather seamlessly. And yet another healthy dose of regulatory and business reality, my friends. Having inexperienced people talking to investigators or auditors spells FAILURE. FDA Doesnt Perform Audits. Saying that FDA conducted an audit of my company isnt accurate, and sitting directly across the table, ISO auditors do not conduct inspections. You could say that Im being too finicky. And youre right It is a sore point with me. But make no mistake, these two actions are conducted and planned much differently. When an investigator performs an evaluation of the Quality System, you experience a bottom up inspection. He looks at one or more instances of quality problems, such as nonconforming device reports, complaints or the Device History Record, and works his way back up through the companys quality system. This method zeros in on specific problems, and evaluates the companys actions that relate to those problems. This practice is reactionary in intent, and usually has a reactionary type of outcome. However, with the top down approach, auditors look at the companys Quality Management System to address quality processes before they actually look at specific quality problems. In the top down approach, the auditor eventually will hit the proverbial bottom when she links observations of each of the subsystems and understand documents and then sample records, rather than works her way from records review backwards toward procedures. The top down approach initializes each subsystem review with an evaluation of whether the firm has addressed the basic requirements in that subsystem by defining and documenting appropriate procedures. This is followed by an analysis of whether the firm has implemented the requirements of that subsystem. You could make a point at this juncture and say that this approach is aligned with the Quality System Inspection Technique QSIT. Frankly, from my experience baseline, the QSIT approach is taught but not used to the extent as advertised. The Authority and Logistics to Conduct an Inspection or an Audit of a Medical Device Company. Section 7. 04a of the Food, Drug, and Cosmetic FD C Act gives FDA the authority to conduct c. GMP QSR inspections of medical device manufacturers. During these inspections, facilities, manufacturing processes, records and corrective action programs are examined by an FDA investigator. The results provide information necessary to evaluate a manufacturers compliance with the device QS Regulation 2. CFR 8. 20. Quite honestly, the ISO audit is more of a business deal than a compliance hurdle. The registrar must meet the requirements of ANSI ASQ National Accreditation Board and have an up to date certification before he steps foot in your facility. The results provide information necessary to evaluate a manufacturers compliance with ISO 1. Your company pays the registrar to conduct this audit in turn, the auditor is paid and all expenses are reflected in the fee. An invoice is generated to consummate the deal. I still wonder about paying an auditor to examine your quality management system objectively. We should talk about that someday. Anyone who manufactures or stores a medical device can be inspected by FDA. A manufacturer is any person who designs, manufactures, fabricates, assembles or processes a finished device. The definition of manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking or specification development, and initial distributors of devices from foreign entities performing these functions. ISO 1. 34. 85 is aligned with this edict but, as I indicated above, ISO Certification is voluntary and can be used to meet the requirements of CE Marking with the authority coming from the Medical Device Directives MDD and your budget. Lets Get Started. Properly managing an FDA inspection or an ISO audit is vital to realize success. Remember, not all FDA inspections and ISO audits turn out to be success stories. Believe me, if youre not prepared, either one of these evaluation activities could fall flat. Knowing your companys intrinsic limitations, upper level managements involvement and the final exit meeting where a best foot forward is essential can make or break the strategic outcome of an FDA inspection or an ISO Audit. Besides managing these logistical variables, your company also must put the best possible objective evidence in front of these evaluators. While there is no magic formula for handling this undertaking, common sense, preparation, a professional attitude and positioning the right people to give the correct answers go a long way to demonstrating QMS effectiveness in a compliant manner. For FDA or ISO, this holds true to form. Having inexperienced people talking to investigators or auditors spells FAILURE. Early Strategy. It is unfortunately true that some inspections are unannounced, but for the most part, FDA inspections, depending upon your relationship and history with the District Office, are conducted with prior notice. Announced or unannounced, there should be a coherent strategy and procedure in place that everyoneyes, everyoneat the company reads and understands to manage FDA inspections and ISO audits. Its not a matter of luck and chance that your company will be a winner at the end of this inspection or audit. A planned, premeditated approach can be of some assurance to a good start. Some company presidents and their staff tout that they are ready every day to defend themselves during FDA inspections analogous to, Bring it on. I have not and will never believe that that type of false bravado instantly spells success. In fact, that approach to the investigator or the auditor usually means just the opposite. Theyre only human Because the business runs smoothly and you make money doesnt mean that the QMS is in compliance, and it surely doesnt mean that your employees are inspection savvy or ready. Companies that drive fire trucks every day commonly have a hard time with FDA inspections and ISO 1. Your ISO registrar and auditor relationship necessitates that you build and seek common understanding as to what the requirements are and the best approach to conduct the audit in a comprehensive and objective manner. There is communication with the registrar and the auditor prior to Day One. There could be requests by the auditor for certain procedures ahead of time. Logistics are spelled out in an audit plan, conversations are held about the best place to stay in the area and are there any good restaurants there. ISO audits are fairly social in nature, in comparison with the no frills FDA investigator who arrives and then acts quite serious, as she should. Common sense, preparation, a professional attitude and positioning the right peopleto give the correct answers go a long way to demonstrating QMS effectiveness in a compliant manner. Preparation Notes. Some fun with ISO 9. Whats so funny about ISO 9. Why not have some fun along the way to ISO 9. Here are a few jokes. Please send your original joke or funny ISO 9. Simply Quality at infosimplyquality. Arguing with an ISO 9. Sooner or later you realize the pig enjoys it More Cartoons. How True Is The Story This is one of those stories that get circulated via fax from time to time. Could the. aerospace company described below get ISO certifiedWhat are your thoughts Once upon time, an aerospace company in Maryland and a Japanese automobile company. Potomac river. Both teams practiced hard. On the big day they both felt as ready as they. The Japanese won by a mile. Afterwards, the American team became very discouraged by the loss and morale sagged. Corporate Management decided that the reason for the crushing defeat had to be found. A. Continuous Measurable Improvement team was set up to investigate the problem. Their conclusion The problem was that the Japanese team had eight people rowing and one person steering. American team had one person rowing and eight people steering. The American. Company Steering Committee immediately hired a consulting firm to do a study on the. After some time and millions of dollars, the consulting firm. Too many people were steering and not enough rowing To prevent losing to the Japanese again next year, the teams management structure was. Steering Managers, three Area Steering Managers, one Staff. Steering Manager and a new performance system for the person rowing the boat to give him. We must give him empowerment and enrichment. That. should accomplish our Total Quality Management goals The next year the Japanese won by two miles. Humiliated, the aerospace company laid off the rower for poor performance, sold the. High Performance award to the consulting firm, then distributed. Eschew Obfuscation. Available in a. poster suitable for printing and displaying. A Little Story. This is a story about four people named Everybody, Somebody, Anybody, and Nobody. There. was an important job to be done and Everybody was sure that Somebody would do it. Anybody. could have done it, but Nobody did it. Somebody got angry about that, because it was. Everybodys job. Everybody thought Anybody could do it, but Nobody realized that Everybody. It ended up that Everybody blamed Somebody when Nobody did what Anybody. Paragraph 5. 5. 1 of ISO 9. Dilbert Does ISO 9. The comic strip Dilbert. ISO 9. 00. 0 on several occasions. They were printed on December 6, 7, 8. September 2. 5, 2. November 7, 1. 99. The four most recent of these are. Dilbert on ISO 9. A reader reported seeing the following on a Dilbert site under things bosses have. Boss to ISO Auditor We use a random number generator to create batch numbers on. An example ISO 9. Procedure on how to have fun on the job A not entirely serious, yet not entirely frivolous, example of an. ISO 9. 00. 0 procedure. An Automatic Procedure Writing Program Write some all purpose procedures and have a little fun. Special Circumstances. ISO 9. 00. 0 is series of quality management standards used throughout the world, except in. Beverly Hill, there they use the ISO 9. Cost Cutting. In an effort to cut costs, some organizations are choosing not to implement. ISO 9. 00. 0. Some are implementing ISO 9. Under this standard every tenth. An ISO 9. 00. 1 Pencil. In an effort to get registered, an organization had written, rewritten and. ISO 9. 00. 1 certified pencil Answer The ISO 9. We certainly hope you dont have this much difficulty meeting the. Control of Monitoring and Measuring Equipment. Kokatat designs and manufactures very technical apparel for work and play. Even though our. gear is technical, very little of it requires measurement precision that. In fact, most measurements are made with simple. We summarize our Control of Monitoring and Measuring Equipment. Procedure in this way. Take me to your ruler. I want to meter. ISO Glossary ISORE Eye strain resulting from writing procedures and work. ISOAP Detergent used to clean up before the Registration Audit. ISO SO Not a full blown nonconformance something thats just. ISOCIAL A party thrown to celebrate passing an ISO audit. ISODA Beverage served at an isocial. ISOB The shedding of tears resulting from receiving too many. ISOHAPPY The pure joy of conformity ISONO NO Activity leading to a nonconformance. BISON Official ISO mascot. ISORRY Response to a Corrective Action Request. ISOMETRICS Used to measure quality objectives. ISOLATION How the management representative feels when. Return to Simply.