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Archive for the ‘QA’ Category

Why 5 Why?

In CAPA, QA, Quality, Quality Management Systems, Root Cause, Root Cause Analysis on October 2, 2011 at 1:03 am

It’s been a while since I made the time for a posting, but I’ve seen a trend of companies overusing the “5 Why” technique so I just felt the need to share this. Enjoy one of my favorite songs too. If you could only hear me sing it in the shower too.

If an auditor finds a nonconformity, the process owner is assigned to a CAPA. The first step of the CAPA process is to investigate the cause or causes. Some auditors recommend using a technique called the “5 Why” process to identify the root cause. PLEASE TELL THEM TO STOP!

The purpose of investigating the causes of a nonconformity is to determine how big the problem is (i.e. – breadth) and what the underlying causes are (i.e. – depth). The 5 Why process only addresses depth. So why do auditors recommend using this tool? Because the concept is simple to understand.

Unfortunately, not every problem is deep. Other problems have more than one cause. There is no magic behind asking why five times. The principle behind this overly-used technique is to encourage process owners to look deeper into the underlying issues instead of stopping at the obvious specific causes. The intent behind implementing a mandatory “5 Why” process is admirable—but wrong.

There are other techniques. Please try using them.

Cause and Effect Diagrams, also known as “Fish Bone Diagrams” or “Ishikawa Diagrams”, are popular tools for investigating problems in the automotive and aerospace industries. This method involves systematically investigating six categories of potential causes. These six categories are often referred to as the six “M’s”: 1) manpower, 2) mother-nature, 3) machine, 4) material, 5) method, and 6) measurement. This technique is particularly effective, because it is a systematic technique that investigates breadth of problems. Is/Is Not Analysis is another tool used to help process owners narrow down the source of a problem when they really don’t know which category of potential causes matter. For example, an investigator might ask the following questions in conjunction with the Cause and Effect Diagrams: 1) “Is this problem observed with any other employees?”, 2) “Did this problem only occur during hot and humid summer months?”, 3) “Did this problem occur in cavity #4 of parts or all cavities?”, 4) “Is this problem observed in cobalt chrome parts only or titanium implants as well?”, 5) “Do we observe failed crystals for only circuit boards that are reworked by hand or for circuit boards that are built entirely by automated assembly as well?”, and 6) “Were all the defective parts inspected using the same thread gauge?”

The above questions are sophisticated questions that may require a cross-functional team to properly answer. It may be necessary to review lots of records from previous lots. It may be necessary to interview operators to gather information that is not included in the records. It might be necessary to design experiments to verify theories. Often it is necessary to use multiple techniques together. The point is that a thorough investigation is not simple.

If a finding is a simple administrative oversight, there are four common causes: 1) insufficient training, 2) insufficient resources, 3) insufficient management oversight, and 4) insufficiently detailed procedures. If multiple people believe that one of these four causes is the problem, look to other areas to see if a similar problem occurs elsewhere—this is investigation of breadth. If the problem is observed in other places, there is a systemic problem that requires asking “Why?” at least one more time. If the problem is isolated, to the area where it was found, then there is probably no need for asking “Why?” again and again.

If your company’s CAPA procedure requires that you use the “5 Why” technique, please consider rewriting the procedure to encourage process owners to “investigate the cause with an appropriate root cause investigation technique such as one of the following…”. This flexible approach requires more thorough training, resources, and management oversight. However, an overly prescriptive CAPA procedure is often ineffective at preventing recurrence of problems.

Never Stop Learning

In ISO 14971, Medical Device, QA, Quality, Quality Management Systems, Risk Management, Training on April 2, 2011 at 2:30 pm

One of my family’s favorite songs is “Come on Get Higher” by Matt Nathanson. Two years ago I tried to purchase this for my wife as a Christmas present. Unfortunately, I couldn’t remember who sang the song. I tried searching the web for the lyrics and found out that Sugarland sings it. I remembered the logo on the album cover, went to the store and bought the album. After I got home I realized that the song wasn’t on the album. Back to the store I went and found another version of the album with some live versions of songs—including “Come on Get Higher.” Just to make sure I had the right song, I decided to open the package and play it. My music video selection for this blog is what I heard. I guess we never stop learning, but I did fall in love with Country music at the age of 38…

I am in Canada, it’s almost midnight, and this client has me thinking so hard that I can’t sleep. I am here to teach the company’s Canadian facility about ISO 14971:2007—the ISO Standard for Risk Management of medical devices.

                Most of the companies that request this training are doing so for one of two reasons: 1) several of their design engineers know almost nothing about risk management, or 2) they have several design engineers that are quite knowledgeable with regard to risk management but these engineers have not maintained their credentials and their last risk management training was to the 2000 version of the Standard. This company falls into the second category.

                I always tell students that I learn something by teaching each course. From this company, however, I have learned so much. This company has forced me to re-read the Standard a number of times and reflect on the nuances of almost every single phrase. I have learned more about this Standard in one month than I learned in the 3.5 years since I first took the course I am now teaching.

                I have developed a model for learning that explains this phenomenon. I call this model the “Learning Pyramid.” At the base of the pyramid there are “Newbies.”

               This is the first of four levels. At the base, students read policies and procedures with the hope of understanding.

                In the second level of the pyramid, the student is now asked to watch someone else demonstrate proper procedures. One of my former colleagues has a saying that explains the purpose of this process well, “A picture tells a thousand words, but a demonstration is like a thousand pictures.” This is what our children call “sharing time,” but everyone over 40 remembers this as “show and tell.”

                In the third level of the pyramid, the student is now asked to perform the tasks they are learning. This is described as “doing,” but in my auditing courses I refer to this process as “shadowing.” Trainees will first read the procedures for Internal Auditing (level 1). Next trainees will shadow the trainer during an audit as a demonstration of proper technique (level 2). During subsequent audits, the trainees will audit and the trainer will shadow the trainee (level 3). During this “doing” phase, the trainer must watch, listen and wait for what I call the “Teachable Moment.” This is a moment when the trainee makes a mistake, and you can use this mistake as an opportunity to demonstrate a difficult subject.

                Finally, in the fourth level of the Learning Pyramid we now allow the trainee to become a trainer. This is where I am at—so I thought. I am an instructor, but I am still learning. I am learning what I don’t know.

                The next step in the learning process is to return to the first level. I am re-reading the Standard and procedures until I really understand the nuances that I was unaware of. Then I will search for examples in the real world that demonstrate these complex concepts I am learning. After searching for examples, I will test my knowledge by attempting to apply the newly acquired knowledge to a 510(k) or CE Marking project for a medical device client. Finally, I will be prepared to teach again.

                This reiterative process reminds me of the game Chutes and Ladders, but one key difference is that we never really reach the level of “Guru.” We continue to improve, but never reach our goal of perfection…For further inspiration try reading “Toyota Under Fire.”

The Perfect Pecan Pie – My Risk Management Plan

In ISO 14971, QA, QC, Quality, Quality Management Systems, Risk Management on February 11, 2011 at 5:41 am

I hope everyone enjoys this selection for the music video. It’s one of my favorite songs by Sting—mostly because it seems to be more upbeat than many of his other tunes. I can almost hear him smiling as he wrote the lyrics.

                This blog posting is a continuation of my previous post on the subject of Risk Management Training, specifically the ISO 14791:2007 Risk Management Standard. In my Risk Management Training, I use the example of making “The Perfect Pecan Pie” as a practical example of applying the principles of Risk Management.

                The first step of the Risk Management Process, or any process, should be planning. My personal preference for planning Risk Management is to begin by brainstorming in order to create a list of potential Quality issues. During the brainstorming session, I will use a Cause & Effect Diagram (a.k.a – “Fishbone Diagram”) to ensure that I have covered as many of the important issues as possible. For those that are unfamiliar with this tool, there are six categories of causes for any problem. These are sometimes referred to as the six “M’s”, because each category begins with the letter “M”:

1)      Materials

2)      Method

3)      Machine

4)      Measurement

5)      Manpower

6)      Mother Nature

                Materials are the single most important component of any product. As the saying goes, “Garbage in equals garbage out.” The right, fresh ingredients are just as important to baking pies as biocompatible materials are to manufacturing implantable medical devices. For example, stale pecans are plain nasty; while granular sugar produces a sickeningly, sweet syrup. Pecan pies are derived from “chess” pies—pies that were cheese-like due to the custard consistency created by cooking butter, eggs, milk and sugar at a low temperature. Therefore, the filling of a pecan pie requires a six tablespoons of unsalted butter, three large cage-free eggs (size matters—don’t get extra large), one cup dark brown sugar (light brown is also too sweet), three-quarters cup light corn syrup, one tablespoon natural vanilla (artificial vanilla tastes totally different and overwhelms the praline flavor), and one cup of pecan halves (I’m told that Georgia pecans picked fresh from the tree are amazing, and roasting them enhances the flavor even more.).

                Manufacturing processes are always the second most important factor related to Quality. For the “Perfect Pecan Pie,” this is also true. Most people will try making their first pie by cooking the filling and the pie crust together. This can produce acceptable results if you are extremely lucky. For custards, however, it is much easier to get consistently beautiful pies by pre-cooking the pie-shell (and sealing it with egg yolk) and pre-cooking the filling separately in a double boiler (always use the right machine for the job). Once the filling gets to the desired temperature (~130F) then the filling should be poured into the pre-cooked crust for the final baking. The final baking should be at 275F for one hour (at sea level).

                If you choose to deviate from any of the above directions regarding the manufacturing process, good luck finding a material review board to approve the release of your pie. If you don’t seal the pie crust, it will leak and you will never get be able to serve an intact slice of pie. If you don’t use a double boiler, you get a mixture of caramel and burnt candy. If you overcook the filling, the consistency will be off. If you undercook the filling, the pie will be uncooked…another way to make it impossible to serve an intact slide of pie.

                When you are cooking a soup, stew or some other dish, measuring is a forgiving process. For baking, the ratio of ingredients, the degree of mixing, and the temperature for baking are critical. Any deviation usually leads to a disaster.

                The next category, manpower, addresses the issue of training. You would think that baking is all about skill. However, like all validated manufacturing processes, proper use of process controls can transform the most inept person into a brilliant baker. Most people struggle with the crust. Packard Consulting, however, has developed a fool-proof method for making a crust. The key is to cool the dough ball and press it into a glass pie dish. The reason for a glass dish is so that you can hold the uncooked shell up to the light to inspect it for “thin spots.” Then you cover the shell with foil, poke it several times with a fork to allow it to vent, bake it for 15 minutes at 400F, uncover it, brush it with egg yolk to seal the crust, and continue baking it for 10 more minutes—or until the crust is a golden brown on the edges.

                Finally, the oven temperature is most critical for the final baking—after pouring the pre-cooked filling into the pre-baked pie crust. In this case, we have an artificial environment (i.e. – Mother Nature). Unfortunately, very few ovens are calibrated accurately and the temperature is very inconsistent throughout the oven. Ovens are hottest on the top rack and the back of the oven is always hotter than the front. Therefore, you need to rotate the pie during the baking process or it gets cooked unevenly. Another critical step is to “map” the oven temperature. You must determine where in the oven (i.e. – which rack position) to place the pie when the oven is set at 275F. In some ovens, the temperature is so far off that it is necessary to raise or lower the setting by 15 degrees.

                Now that I have given you the recipe for the “Perfect Pecan Pie,” you might be tempted to make one. Before you do, I recommend getting a piece of paper and documenting every step you take—including any visual observations, the taste of the dough, and the taste of the filling. This information will become your risk management file. As you perfect your technique, learn the idiosyncrasies of your kitchen appliances, and you find sources for each ingredient…you will need to prevent these secrets from becoming lost. Your collection of notes is a Risk Management File.

                You have now completed Section 3 of the 14971:2007 Standard. Keep drooling and I promise to serve up another slice:)

 PS – Here’s a cool drumming lesson that gave me a much better appreciation for the layers of rhythm within the song I chose for this blog’s background entertainment.

If I had a rocket launcher…

In Elsmar Cove, International Standard, ISO, ISO 13485, Management Representative, Management Responsibility, QA, Quality, Quality Management Systems on January 21, 2011 at 12:53 am

This week’s music video selection was recommended by my friend Greg. We were eating dinner together at 1776, and he was kind enough to share this amazing musician with me. I’m not a guitarist but he pointed out that Bruce Cockburn has a very unique style. He plays three different parts simultaneously. His thumb plays base on the top string while the other fingers play two separate melodies. WOW!

                 Are you frustrated? Do you wish for a rocket launcher? Maybe you would aim it at the C-level offices and pull the trigger.

                Sometimes we hear phrases like: “Well that’s just an ISO requirement.” This obvious lack of support by top management is what frustrates every Management Representative in the world.

                There was a question posted on the Elsmar Cove website on January 10th (see previous blog for the link). In just 10 days there have been 153 postings in response to the original question. As I read through the various postings I saw several comments about a lack of support by top management. Rocket launchers are NOT the answer, but maybe a heavy bat…

                A little over a decade ago I was still learning how to supervise people. In an effort to educate myself further, I read a book (sorry can’t be sure which book anymore). In this book, the boss gave an employee a card with a picture of a baseball bat on it. The instructions provided with this magical card were to use it only when the boss failed to pay attention and the employee had something important to tell him.

                We all wish for a magical baseball bat, but unfortunately we are M-A-N-A-G-E-R-S. Along with the awesome title comes awesome responsibility. Managers are responsible for leading others. Subordinates are not the “others” I am referring to. The “others” are peers. If you cannot persuade your peers to support you, then you will fail as a manager. The Quality Department cannot fix all the problems. In fact, my philosophy is that Quality is responsible for recommending improvements, training people, and helping to implement. We assign corrective actions, but we should be assigning them to the process owner (i.e. – Manager) that is responsible for the area where the problems were created.

                If you need help persuading the unenlightened, try picking a project that is critical to the success of the stubborn one. If you can show someone that is currently a detractor how they can apply the Quality principles to help solve their problems, then you will have a convert. Converts become strong supporters. If the stubborn one happens to be at the top, figure out what the CEO’s initiatives are. Initiatives are easy to identify; they talk about it at least twenty times a week. Try showing the CEO how their initiatives can become Quality Objectives. Show them with graphs. Show up with solutions to their problem. Use the CAPA process as a framework. Show them how the management TEAM can fix it.

                If nothing seems to be working, you can always try reviewing some FDA MedWatch reports too–just to scare the crap out of the boss.

Management Representative

In Elsmar Cove, ISO, ISO 13485, Management Representative, Management Responsibility, QA, Quality, Quality Management Systems on January 18, 2011 at 5:05 pm

The video music selection for this week was a tune I heard at a restaurant called “1776” in Crystal Lake, IL. The restaurant played Chris Isaak recordings for the entire meal. Maybe the satellite radio station was stuck on the letter “I”.

 The idea for this posting was from a thread I found on Elsmar Cove:

http://elsmar.com/Forums/showthread.php?t=45658

One person posted a question about the requirement for the Management Representative (MR) to be a member of the organization’s management (see section 5.5.2 of ISO 9001:2008). Companies that are seeking initial certification sometimes struggle with this requirement. Some struggle because they do not have anyone in-house that is sufficiently trained to be the MR. Other companies struggle, because they are very small and outsource their QA functions to a consultant. The following blog is targeted at helping these companies.

     I audit companies to the ISO 13485 (medical QMS) & 9001 (QMS) Standards. The intent of both Standards was always to have the MR be part of management, but some companies did not interpret the Standards in this way. With the 2008 revision of 9001, the possibility of misinterpreting the meaning is much less likely. The companies that receive findings during the Stage 1 or Stage 2 audit for this requirement usually fall into one of two categories. Category #1: our company is small and the only person that really knows enough about ISO requirements is not a member of management. Category #2: our company is small and we outsource QA functions.

   The good news is that any manager can be assigned the responsibility of being MR. One of my clients assigned this responsibility to the VP of Sales. Another company assigned this responsibility to the Director of R&D. Both of these individuals had to put in the time to learn about Quality Management Systems, but both have embraced the challenge and I have learned a lot from them. They have a different perspective and bring a lot of value to the MR role.

    The bad news is: whomever you assign has to learn enough to be competent in the role.

   The definition of “Management” is typically a stumbling block. Most people think of managers requiring that they have other people reporting to them. This is not an absolute. The MR should report directly to a top manager such as the President or CEO to prevent conflicts of interest. As a manager, they should not require a lot of direct supervision and the President or CEO should not be overly burdened by adding one person to their list of direct reports.

   Some auditors like to see a “deputy MR” identified. My advice is to have the CEO or President sufficiently trained that they can be the “back-up” when the MR is on vacation. Every manager should know enough about their subordinate’s job duties that they can “fill in.”

   MR’s should be involved in senior staff meetings too, but not necessarily at the same frequency as every other senior staff manager. Typically operations and sales have the most frequent meetings with the CEO–often weekly. Finance is typically monthly. HR and the MR might be bi-monthly or Quarterly. Communication of the status of Quality Objectives should be regular reports to all senior staff, but you don’t have to have a Management Review to communicate the status. If the company is small enough to have only one QA person, there probably isn’t a need for more than one or two management review meetings per year.

   If your company has a finding against clause 5.5.2, I recommend the following actions:

1. Assign a person that is already a member of your senior staff as MR

2. Document the responsibility in the person’s job description

3. Document the responsibility in the org chart

4. Assign the person’s direct supervisor (typically the CEO or President) as a “deputy MR”

5. Find a good webinar on ISO training for the new MR and their boss (ideally one with a quiz and a certificate)

6. Have the new MR develop a 45 minute presentation for the senior staff on the topic of Management Responsibilities. This training should cover all of section 5 in the Standard.

7. Give the senior staff a 15 minute multiple choice quiz to evaluate effectiveness of the training.

8. Have the new MR discuss delegation of various management review inputs (see section 5.6.2) with their boss. Quality should be a shared responsibility and Management Reviews will be more effective if everyone takes part.

The Secret to Successful Training

In Internal Auditing, International Standard, ISO, ISO 13485, Medical Device, QA, QC, Quality, Quality Management Systems, Training on January 7, 2011 at 3:32 am

About 10 years ago my CD collection was stolen and I haven’t heard this tune since. Sass Jordan might be a little raw for your average professional but everyone needs to loosen up sometimes. Just-in-case you were wondering, I think this CD (Rat) was next to the Greatest Hits of Ella Fitzgerald—which they left behind. I love the singing by both women but for very different reasons.

Recently a client asked me to create a training course on how to train operators. I could have taught the operators myself, but there were so many people that needed training that we felt it would be more cost effective to train the trainers.

                Usually I have multiple presentations archived that I can draw upon, but this time I had nothing. I had never trained engineers on how to be trainers before—at least not formally. I thought about what kinds of problems other Quality Managers have had in training internal auditors and how I have helped the auditors improve. The one theme I recognized was that most auditors needed feedback.

                I finally decided to use the Deming Cycle (Plan-Do-Check-Act, or PDCA) as my framework for the training. Most QA Managers are very experienced and have little trouble planning an audit schedule. The next step is to do the auditing. The problem is that there is very little objective oversight of the auditing process. The Standard requires that “Auditors shall not audit their own work.” Therefore, most companies will opt for one of two solutions for auditing the internal audit process: 1) hire a consultant, or 2) ask the Director of Regulatory Affairs to audit the internal auditing process.

                Both of the above strategies meet the requirements of the Standard, but neither strategy helps to make internal auditors better. I have interviewed a lot of audit program managers, maybe 50+, and the most common feedback for auditors is “change the wording of this finding” or “you forgot to close this previous finding.” This type of feedback is related to the report writing phase of the audit process. I rarely hear program managers explain how they help auditors improve at the other parts of the process.

                When auditors are first being trained we typically will provide examples of best practices for audit preparation, checklists, interviewing techniques AND reports. After the auditors have been “shadowed” by the program manager for an arbitrary three times the auditors are now miraculously “trained.” Let’s see if I can draw an analogy that will make my point…

                That kind of sounds like watching your 16 year-old drive the family car three times and then giving them a license. I guess that’s why my new Ford Festiva was severely dented on all four sides within 6 months. You might think my father was a Saint, but I think he might have totaled his tenth car by age 18. At least I contained the damage to one vehicle.

                Anyway the key to training auditors to audit, or anyone on anything, is consistent follow-up over a long period of time.

                The question is…was my training successful?

                Well, how much follow-up training of the trainers did the client ask for?

Risk Management – It’s Not My Job

In Contract Manufacturers, International Standard, ISO, ISO 14971, Medical Device, QA, QC, Quality, Quality Management Systems, Risk Analysis, Risk Management, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 5, 2011 at 4:12 am

There’s no deeper meaning to this week’s YouTube selection. I just thought I would share one of my favorite guitar soloists with you. The recording quality is only good, but just watching Tim play reveals how freakishly good he is. I highly recommend the live CD with Dave Matthews and Tim Reynolds. If someone knows of a better quality recording that I can post in my blog, please let me know.

Have you experienced a discussion similar to this?

Auditor: “How do you manage risk throughout the production process?”

Auditee: “That is the responsibility of our customers. We will prepare a risk analysis if customers pay for it, but usually customers do the risk analysis.”

Most contract manufacturers in the medical device industry exclude design from their Quality Management Systems. Unfortunately, most of the contract manufacturers also associate risk management with only the design process. Risk Management cannot be “not applicable” in an ISO 13485 Quality Management System. The requirement of section 7.1 is: “The organization shall establish documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained.” The Standard also references ISO 14971 as a source of guidance on Risk Management.

                For a contract manufacturer, compliance with ISO 14971 is not my primary concern as an auditor. My primary concern is to verify that contract manufacturers analyze risks associated with the processes that they perform and do their best to minimize those risks. What I don’t understand is why more companies don’t want to have strong risk management process. Risk management is how we prevent bad things from happening. Bad things like scrap, complaints and recalls. Should we expect our suppliers to have a strong risk management process?

                Duh.

                Contract manufacturers should be doing everything they can to get better at risk management. During pre-production planning they should be asking, “What happens if…” The contract manufacturer knows best HOW things will fail in production, while the customer knows best WHAT happens when things fail in production. In order to be safe and effective, both companies need to collaborate on risk analysis.

                The reason companies avoid doing risk analysis is because it’s time consuming and tedious.

                 Too bad, so sad.

                 Balancing my checkbook is time consuming and tedious too, but I balance my checkbook to prevent an overdraft charge. Not doing risk analysis can be much more painful. Scrapping out a part can cost tens or hundreds of dollars. Complaints can cost thousands of dollars. Recalls can cost millions of dollars.

                If I owned a contract manufacturing company, I would make sure that everyone in the company is involved in risk management, because we don’t want scrap, we can’t afford mistakes that lead to complaints, and a recall will put us out of business.

Supplier Evaluation – Take 5

In Forward to MDA, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 3, 2011 at 9:47 pm

This blog has been moved to the following location and the name has been changed: http://bit.ly/SupplierEval-take5.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Supplier Evaluation – Less is More

In Forward to MDA, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 2, 2011 at 8:26 pm

This blog has been moved to the following location: http://bit.ly/Less-is-more.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Elsmar Cove – Wikipedia for QA

In Elsmar Cove, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 2, 2011 at 4:11 pm

While you are reading, here’s a seasonal favorite from one of my favorite singers (also from North Texas State) and a country singer that everyone will recognize.

After my last blog posting I planned to write a blog on supplier evaluation and re-evaluation. After a busy December, I finally have time to write again. Before I share my own ideas, I thought I would share a great resource with you: The Elsmar Cove Forum.

                Most of the people reading my blog are probably aware of a website called Elsmar Cove, but I think most people visit this site only when they need a quick answer to a question. It’s sort of like Wikipedia for Quality Assurance. Marc Smith is the creator of Elsmar Cove, http://elsmar.com/, and the forum just had its 15-year anniversary. This is a no frills website that has fantastic content and very little advertising. People from all over the world (~18,000 active participants) are contributing daily to this forum and many of the contributors are Quality and Regulatory experts. I like to use the site to keep up on best practices and trends in Quality. It also gives me an opportunity to learn from other types of Quality Systems such as: AS9100, TS16949, and ISO14001.

                Someone I used to work with had a saying he learned from his first boss: “A picture tells a thousand words, but a demonstration is better than a thousand pictures.” Therefore, I thought I would try to demonstrate the power of Elsmar Cove by researching best practices in supplier evaluation. Step 1: The first thing you do is visit the site. Step 2: Type “supplier evaluation” into the Google™ custom search. This will produce 100’s of links within the Elsmar Cove Forum related to supplier evaluation. Step 3: Skim the search results to find the entry or entries you are looking for. These search results include a supplier evaluation survey that you can download and adapt to your own company. If you need a quick solution, this is really fast and free.

                Another approach is to limit your search to Forum discussion threads. You can do this by going to the Forum Discussion page: http://elsmar.com/Forums/index.php. If you click on the tool bar link for “search” a pop-up window will appear. If you type “supplier evaluation” in this search bar, you will see 531 results presented in reverse chronological order. Below are a couple of threads that I thought were particularly good:

Benchmarking Supplier Certification Programs

http://elsmar.com/Forums/showthread.php?t=42595&highlight=supplier+evaluation

Service Supplier Rating where objective pass/fail data is not available

http://elsmar.com/Forums/showthread.php?t=44412&highlight=supplier+evaluation

Choosing Supplier Evaluation Methods – Determining what a Critical Supplier is

http://elsmar.com/Forums/showthread.php?t=10951&highlight=supplier+evaluation

Supplier Approval for Distributors of Equipment

http://elsmar.com/Forums/showthread.php?t=43508&highlight=supplier+evaluation

Second party audits – Supplier audits or product audits?

http://elsmar.com/Forums/showthread.php?t=30966&highlight=supplier+evaluation

How you do Receiving Inspection for Chemicals?

http://elsmar.com/Forums/showthread.php?t=44951&highlight=supplier+evaluation

Supplier Evaluation Responsibility

http://elsmar.com/Forums/showthread.php?t=43756&highlight=supplier+evaluation

                I hope you find Elsmar Cove to be a useful website, and my next blog will share a few ideas for supplier evaluation of my own.

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