How Santa’s Kitchen Prepares for an FDA Inspection


2017-bl-santas-kitchen-1-page-imageIn addition to the billions of toys produced annually by Mr. Santa Claus and his merry elves, there are a great deal of candy, cookies, chocolates, cakes and additional delicate treats produced in Santa’s kitchen facilities at the North Pole.

Whether the various sweets consist of peanut butter fudge, chocolate truffles, candy brittle, homemade marshmallows, popcorn candy and/or snowy white fudge, there are sure to be millions of well-behaved children enjoying the fruit of Santa’s labors on an annual basis.

However, before Santa and his reindeer can spread the sugar-coated cheer, he and his elves must be inspected and/or audited by certified auditing bodies and similar organizations from around the world. Why? Because Santa must prove that the sweet treats he manufactures measure up to high quality standards for all children everywhere.

For example, when Santa brings candy and chocolates to children in Brazil, he must meet standards set by the federal food regulations of that nation. To provide candy to children in the United States of America (USA), Santa’s creations are subject to the U.S. Food and Drug Administration’s (FDA) food and beverage regulations. The FDA is a federal agency and ensures the safety of pharmaceuticals and medical devices as well food and drug products sold or distributed within the United States. Even if Santa Claus doesn't work in the United States — he doesn't — it’s important to remember that Santa’s candies still need to conform to U.S. standards of quality to be distributed throughout the United States.

Don’t worry though. Santa doesn’t get nervous about inspections. He maintains a twinkle in his eye and a mouth drawn up like a bow because he knows he has inspection preparation down to an art and a science.

By adhering to the eight rules described in this article, Santa and his elves have easily passed every FDA inspection to date.

Rule 1: Quality Management is King, Documentation is King and an Electronic EQMS is King
Santa Claus has collected some of the most delicious candy and cookie recipes in the world but the best recipes don’t guarantee perfect results. In Santa’s case, there are millions of things that could go wrong, so careful quality management processes are required. To ensure quality, Santa has carefully developed these processes and has created hundreds of standard operating procedures (SOPs) to ensure they are carried out with low margins of error (a magical level of seven or eight sigma is often obtained in Santa’s North Pole location).

The SOPs created by Santa detail — among other things — ingredient requirements, mixing times, specifications for combining ingredients, boiling and/or baking temperatures, how the facility’s current temperature or humidity levels might require recipe variations, conversion table specifications, and required calibration and maintenance instructions for every piece of equipment. Several SOPs — or many — may be included in one process (producing the perfect holiday stocking for example) and every process is thoroughly documented.

Santa also knows that it isn’t enough to have SOPs. He has thousands of them but the quick storage, retrieval and version controls of these SOPs are of the utmost importance. For this reason, Santa utilizes an enterprise quality management system (EQMS) which provides document management capabilities (including quick search and retrieval capabilities as well as version controls) so the latest versions of an SOP are always available to the elves on the manufacturing floor (via their electronic tablets) and to Santa Claus himself.

Rule 2: Calibrate All Machinery on a Regular Basis and Maintain Calibration and Maintenance Records
In Santa’s kitchen facilities there are thousands of machines both large and small. These tools include industrial vats, mixers, measurements tools, etc. These machines and their use in relation to specified recipes are documented in SOPs and require specific maintenance and calibration over time. Some machines, for example, should be calibrated after three uses, some after ten and some after 50. There may also be machines needing calibration after coming in contact with specified ingredients.

All maintenance and calibration activities must also be recorded carefully (via electronic tablets on the manufacturing floor for speed) and uploaded to the secure EQMS where it can be accessed by any approved user. If an error of any kind is made during the manufacturing process, the calibration and maintenance records can be analyzed to determine if corrective and preventive actions will be necessary for future batches. Further risk assessment (see rule #6) may also become necessary.

Rule 3: Adhere to In-house Quality Control Processes and Document Them
For every recipe there should be “quality checks” at various points of the creation process. Was the sugar container closed before use (to prevent high levels of moisture) in the recipe? Was the sugar carefully measured with the appropriate tools? Was the syrup mixture carefully checked for temperature before it was mixed with the remaining ingredients? These steps, or quality control points, must be documented, adhered to and recorded when complete. Many of these steps — if not all — will be documented in SOPs.

At every quality control checkpoint a record must be made of the results and that record must be maintained in the EQMS. When errors occur, Santa can verify that quality controls have been taken, or have not been used, and act quickly to correct the error or prevent it in the future.

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Rule 4: Take Effective Action to Make Corrections and Prevent Further Errors

Even merry Santa and his magical elves make mistakes and because they know they make mistakes, they have created processes that stipulate the actions to take when a deviation or a nonconformance event occurs during the creation of a recipe. When these events occur, Santa and his elves do their best to correct the error, and then in many cases, launch an investigation to prevent further errors from happening again. These efforts to prevent future errors demonstrate a commitment to continuous improvement which the FDA requires from the food and beverage companies it regulates.

Santa manages corrective and preventive actions (CAPAs) effectively with an electronic EQMS. A CAPA form within the EQMS is used to record errors and contextual information. This information can then be used to launch a CAPA investigation which may result in taking preventive actions (i.e, re-training, re-writing an SOP, creating a new process, etc.)

Rule 5: Training to Quality Processes

Santa has many elves who need to be trained. New elves must be trained. Well-educated bakers and candy makers need to be trained to the overall quality management strategy and all elves must be trained to specified SOPs. They will also need to be re-educated on a regular basis to avoid error or to fulfill the requirements of a CAPA investigation.

The FDA is known to cite companies for lack of training but in the case of Santa’s kitchen facilities, training citations rarely occur as Santa knows the importance of training regularly and often.
 
It is also worth noting that developing training processes and managing those processes can take a great deal of time. With his EQMS, Santa has created training modules that are delivered to the correct group(s) of elves (i.e, new employees, specific SOP training, regular re-training or re-training related to a CAPA-triggered event). Seeing these training processes well organized and automatically managed is very impressive to an FDA inspector. 2017-bl-santas-kitchen-2-page-image

Rule 6: Risk Management

Risk management processes are an important aspect of overall quality management. Santa and his elves conduct risk assessment on key areas and aspects of their quality management processes. Areas that include the possibility of supply chain disruptions, equipment failure, employee injuries (even elves get injured in the kitchen sometimes), food contamination or reports of customer complaints (i.e, kids that get sick after eating the product) take precedent and must be carefully assessed. Risk strategies must be developed so that backup plans can quickly be launched when failure occurs and/or risk levels become too high.

With an EQMS, the risk management plan is easy to maintain and edit (by approved users only). Risk assessment and risk analysis reports can also be kept and associated (or linked) to other related documents within the quality management system. With Santa’s expert elves and a great EQMS, it’s easy for Santa to reach all of the children of the world with the delicious candies and cakes he loves to give away.

Rule 7: Management Responsibility

When an FDA inspector comes to call on Santa Claus, this expert expects that Santa himself is involved in the process of quality management from a high level. He must understand his organization’s quality processes and how they fit into and contribute to the company’s overall goals and objectives. An executive, such as Santa, must also understand why certain deviations from quality processes merit his quick attention. Without management involvement, the big picture — of which quality is an integral part — may be lost in a cloud of confusion.

With an effective electronic EQMS, high-risk deviations and nonconformance events can automatically trigger a management review and subsequent CAPA investigations, document updates, training and any other measures that may be necessary.

Rule 8: Only Answer What the Inspector Asks

Though Santa and his elves enjoy a good time they are “all business” when it comes to an FDA inspection. They know that the FDA doesn’t have time to inspect every facility in the world so when an inspector does show up, every minute must be time well spent! As a rule, Santa has learned that when an inspector asks a question he and his elves must find the answer to that question and must not waste time mentioning extraneous issues. FDA inspectors already know what they are looking for and aren’t looking for anything more or anything less.

 
An EQMS helps Santa and his elves stay on target when an FDA investigator comes to call. Santa’s elves are able to quickly search for and pull up requested documents, reports or additional information requested by the FDA investigator.

Conclusion: An EQMS for the Holidays
When you reach into your stocking this year and pull out a big red, green and white candy cane perfectly shaped as a shepherd’s crook or some other sweet delicate shape, remember that it’s taken a lot of careful planning, quality management and an EQMS for Santa and his elves to bring it to you.

Happy Holidays!


marci-crane-from-GxP Lifeline blog Marci Crane is a regular contributor to GxP Lifeline and enjoys a little time in her own tiny kitchen during the holidays.