A Quality Management Look into Santa's Workshop


Gert Sorensen

Courtesy of Timothy Lozier who wrote this for Medicaldevicesummit.com:

I really enjoy the holiday season. I love the change in season, the holiday specials, the gifts, all of it. Most of all, I love the Santa Claus concept. Here is a man, a Jolly old Elf if you will, who single-handedly delivers the worlds presents in a single night. Furthermore, he and his elves manufacture nearly $250 billion in merchandise every year. This must be some operation!

So, clearly Santa has some high-tech systems in place to bring the presents to the children of the world. Let's look at what Santa is running in his Quality Management System:

1. Document Control, linked to Product Data Management:
Santa HAS to have a document control system in place. Here you have millions and millions of letters being sent every year that need to be cataloged, identified and added to the production list. Each product item that comes into the list needs to have a unique identifier and keywords based on type of toy. Document Control Systems provide the centralized location for storing documents based on product, customer (or kid), and then can build each request in a product list. Product Data Management helps to take the requests and build a bill of materials for each customer. Furthermore, Santa's Naughty or Nice list needs to be housed somewhere, and probably has a revision control number somewhere in the 300's. Every year, Santa needs to update his list, then check it twice. Document Control systems have the workflow and business rules to route documents to the appropriate individuals in a pre-defined schedule. So Santa can check the list two, three, or one hundred times, redundancy checking protocols can be built into the system through Document Control.

2. Audit Management: While we're on the subject of Naughty or Nice, let's look into how Santa determines how to update his list. My guess is he's got a top-notch audit management system. Throughout the year, Santa can schedule Audits in the system, and be notified when it is time to audit a process or region - say the Eastern seaboard. He can then run through an automated checklist on his computer or even iPad (yes, Santa TOTALLY is an Apple guy), and update the Naughty or Nice list. Audit Management tools also provide the ability to trigger events based on audit findings. So, Santa is able to automatically update his List based on an audit finding, or automatically add another kid to the "Coal Distribution Queue."

3. Training Management: Based on current market demand estimates and the growing human population, Santa's workshop is growing by at least 20 percent each quarter. So, it's safe to say he's hiring. Elves looking to work in Santa's workshop must undergo an extensive and ever-changing Training program. Each elf must be well trained in multiple products, and be able to operate various types of machinery. Organizing and maintaining a training schedule like this is impossible without an integrated Training system. Using Training Management tools, Santa would be able to update training records with every change to product versions or new product introduction, and each employee would be automatically notified when new training is due. This training can be linked directly to the North Pole Document Control system, and they can update their training records automatically. Each Elf would then be trained and knowledgeable in the areas within their requirements group in real-time, providing a seamless training program.

4. Complaint Handling and Corrective Action: Seriously? Who would ever COMPLAIN to Santa? That seems like a one-way trip to the Naughty list if you ask me. Nevertheless, Santa needs a method to track and measure “post-market” feedback. Toys that might have broken, perhaps a few cosmetic errors, maybe the occasional "shooting your eye out" with a Red Ryder carbine-action, two hundred shot Range Model air rifle with a compass in the stock and a thing which tells time. Complaint Handling systems help to take this valuable information and issue Corrective Actions based on the severity and risk of the event. I would imagine most kids are happy not to have coal in their stocking, but having an integrated Complaint Handling system is a handy piece of technology, especially when you have millions of products and billions of consumers in your market.

5. Design Quality/FMEA: Let's take a leap and assume that Santa has access to all the product design files of the major manufacturers. We won't ask where he got them, and we will turn a blind eye to trademark/patent infringement for the moment. He needs to ensure that Quality is built into his products from Design to production. Using Quality Management tools such as FMEA, Santa can look at the product design and determine potential Failure modes and take steps to mitigate risks in the product. FMEA is a critical tool used by many organizations to help identify and prepare for any potential risks in design, and account for them in a proactive method. Santa is no different, except he has a bit of Christmas magic on his side...

6. Monitoring and Inspection: When your main market is impressionable little children, you want to make sure that your product not only matches the design, but also that it is the highest quality possible. Santa's workshop has an extensive inspection team that reviews each lot that comes off the line and provides an in-depth inspection. Recording this inspection data can be extremely difficult by hand, which is why Santa uses an integrated Inspection system linked to the Quality Management System. Rather than lumber about in a manual inspection system, Santa's system incorporates real-time tracking with his ERP system, and when product lots are found to fail an inspection, the data is imported into the Quality Management System. Once in the system, failed products need to be handled quickly and efficiently.

7. Nonconformance Management: Santa's biggest concern is meeting customer demand while eliminating any defects along the way. Furthermore, Santa does not want to waste materials along the way. Linking into Santa's top notch (probably German) ERP system is his Nonconformance (NCM) tracking system. Once a product lot is put on hold, the NCM system is integrated to the ERP and inherits the product data, inspection data and all relevant information. The Elves then get to work on processing the Nonconformance, sending the record to a material review board, and then determining a disposition type: Scrap, rework, reuse, etc. Once determined, the NCM system notifies the ERP the status of the lot, and production can resume, without wasting any materials and meeting the demands of the consumer. Santa's system is designed to operate efficiently and eliminate as much double-entry as possible, which is why he uses best in class Integrated NCM and inspection tools.

8. Distribution: Okay, it's not really Quality's "job" to push the product out the door and down the chimney, but there are some quality-related considerations. Certainly he would need to have a special crew of Elves to go on ahead and perform on-site inspections of the “drop-zones” - checking the houses, ensuring the proper Quality Standards are met.

So, Santa's operation is an impressive one—he has a reputable "brand" and needs to protect it through providing the highest quality products possible. One way to ensure high quality is to implement the necessary tools that are important to any organization. Quality Management systems help to manage and track the activities associated with any organization's operations, and technology has provided the platform to take Quality to the next level. So, as you settle in for a long winter's night, remember that Santa is providing Quality products to all, and all in one night! (ho ho ho)


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