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ISO 14971 Deviation #5-Risk Control for CE Marking Medical Devices

The author reviews ISO 14971 Deviation #5, which is specific to selecting risk control options and protective measures for CE Marking medical devices.

%name ISO 14971 Deviation #5 Risk Control for CE Marking Medical DevicesIf your company is CE Marking medical devices, you are required to satisfy the Essential Requirements for Safety and Performance as defined in the three European Directives (i.e., – the MDD, http://bit.ly/M5MDD; the AIMD, http://bit.ly/AIMDDirective; and the IVDD, http://bit.ly/currentIVDD. Throughout these Essential Requirements, there is a requirement to reduce risks “as far aspossible” (AFAP) by implementing risk controls. At one time, the expectation was for companies to implement the state of the art with regard to risk controls, and “state of the art” was interpreted as the latest version of the harmonized ISO Standards. However, lawyers dominating the European Commission appear to disagree with the status quo.

Therefore, in 2012, the European National (EN) version of the Medical Device Risk Management Standard was revised (http://bit.ly/ISO14971-2012changes). There is no change to the content of Clauses 1 through 9. Instead, the European Commission identified seven content deviations between the 14971 Standard and the EU Directives. These deviations are identified and explained in Annexes ZA, ZB, and ZC. This blog is the fifth installment of Medical Device Academy’s seven-part blog series on this topic. The goal of the series is to identify solutions for meeting the Essential Requirements by suggesting changes to the current best practices of implementing a risk management process for medical device design.

Discretion as to the Risk Control Options/Measuresiso14971 deviation 5 ISO 14971 Deviation #5 Risk Control for CE Marking Medical Devices

Essential Requirement 1 and 2 require that risk control options are implemented for all risks prior to determining acceptability of residual risks. Essential requirement 2 also requires manufacturers to implement all risk control options—unless the risk controls do not further reduce risk.

Clause 6.2 of the 14971 Standard suggests that you only need to use “one or more” of the risk control options, and Clause 6.4 indicates that further risk control measures are not needed if the risk is acceptable. There is a clear contradiction between the intent of the Standard and the Directives.

If risk acceptability has no impact upon whether you will implement risk controls, there is really no need for performing a preliminary risk evaluation. Therefore, I have three recommendations for changes to your current risk management process:

  1. Ignore Clause 5 of the 2007/2009 version of ISO 14971
  2. Eliminate the second step of risk assessment from your flow chart for risk management (see Figure 1 from the 14971 Standard)
  3. Define risk management policies upon clinical benefits, rather than absolute risks

Instead of performing a preliminary risk evaluation (Clause 6.5), risk/benefit analysis should be moved to Clause 7, where the evaluation of overall residual risk acceptability is required. By making this change, risk controls will be implemented, regardless of risk acceptability, and acceptability of risks will be dependent upon the risk/benefit analysis alone.

Impact of this Deviation

Implementing changes to your risk management process to address this deviation has great potential to impact the design of devices—not just the risk management documentation. Design teams will no longer be able to stop the design process with an initial design that has an “acceptable risk.” Instead, design teams will be forced to implement additional risk controls and protective measures for device designs that already have a low risk of harm for certain failure modes.

The requirement to implement additional risk controls will increase the cost of devices that may have been relatively safe without the risks controls. For example, if a device is not intended to be implanted, but it is a potential foreseeable misuse, then your company may have used the instructions for use to communicate the residual risk associated with misuse of the device. However, now your company will have to implement design controls (e.g., –selection of materials suitable for implantation) to eliminate the risks associated with misuse, and protective measures (e.g., – radio-opaque thread) to help retrieve product that was implanted in an “off-label” usage.

For anyone interested in risk management training, please contact Rob Packard directly by email: rob@13485cert.com.

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ISO 14971 Deviation #4: Risk/Benefit Analysis

%name ISO 14971 Deviation #4: Risk/Benefit AnalysisThe author reviews ISO 14971 Deviation #4, which is specific to the requirement for risk/benefit analysis.

This blog is the fourth installment in our seven-part series, which  reviews each of the content deviations between the three device directives for Europe and international risk management standard (ISO 14971:2007). The deviations were identified in the new European National version of the Standard released in 2012. There was no change to the content of Clauses 1 through 9 in ISO 14971, but the there were seven deviations from the directives identified by the European Commission.

Discretion as to Whether a Risk/Benefit Analysis Needs to Take Place

The fourth deviation is specific to the requirement for risk/benefit analysis. Clauses 6.5 and 7 of the 14971 Standard both imply that a risk/benefit analysis is only required if risks exceed a threshold of acceptability, and Annex D.6.1 indicates that “A risk/benefit analysis is not required by this International Standard for every risk.” However, essential requirement 1 and 2 require that you perform a risk/benefit analysis for each risk and overall residual risk. Essential requirement 6a also requires a risk/benefit analysis as part of the conclusion in your Clinical Evaluation Report (http://bit.ly/ER6aMEDDEV).

Your company may have created a risk management procedure, which includes a matrix for severity and probability. The matrix is probably color-coded to identify red cells as unacceptable risks which require a risk/benefit analysis, yellow cells that are ALARP and green cells that are acceptable. Based upon the guidance provided in ISO 14971, your company probably identified that a risk/benefit analysis is only required for a risk which falls in the red zone of the matrix where the risk is “unacceptable.”

Deviation 4 ISO 14971 Deviation #4: Risk/Benefit Analysis

Unfortunately, this approach is not compliant with the European Directives, because the Directives require that a risk/benefit analysis be performed for each risk and all residual risks—not just the risks you identify as unacceptable. The fourth deviation between the ISO 14971 Standard and the Essential Requirements of the European Directives is relatively simple to address with a change to your risk management process. To comply with EN ISO 14971:2012, the “red zone” should not be labeled as risk/benefit analysis, because even risks in the “green zone” require risk/benefit analysis.

Impact of this Deviation

In a previous blog (http://bit.ly/14971Dev2), we determined that all risks must be reduced by the implementation of risk controls. In this blog, we established that after implementation of risk controls, all residual risks must be subject to a risk/benefit analysis. Your company will need to eliminate the use of a risk evaluation matrix like the one shown above. Instead of relying on a risk management policy for evaluating the acceptability of risk, your company should be performing a risk/benefit analysis to determine the acceptability of risks.

The best way to integrate risk/benefit analysis for evaluation of acceptability of all risks is to integrate this with the clinical evaluation process. In addition to using clinical literature, clinical study data and post-market surveillance as inputs for your clinical evaluation, your company should also be using residual risks as inputs to the evaluation. The clinical evaluation should be used to assess the significance of these residual risks, and verify that there are not any risks identified in the clinical evaluation that were not considered in the risk analysis.

In order to document that your company has performed a risk/benefit analysis for each residual risk, you will need to reference the risk management report in the clinical evaluation and vice-versa. Both documents will need to provide traceability to each risk identified in the risk analysis, and conclusions of risk acceptability will need to be based upon the conclusions of the clinical evaluation.

Once the product is launched, you will need to update the clinical evaluation with adverse events and other post-market surveillance information. As part of updating clinical evaluations, you will need to determine the acceptability of the risk when weighed against the clinical benefits. These conclusions will then need to be updated in the risk management report—including any new or revised risks.

If you are interested in risk management training, please send your request to: rob@13485cert.com.

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7 Deviations within EN ISO 14971:2012: Deviation #3-Risk Reduction

%name 7 Deviations within EN ISO 14971:2012: Deviation #3 Risk ReductionThis third blog in a seven-part series reviews deviation #3-risk reduction within the EN ISO 14971:2012 Standard.

In 2012, the European National (EN) version of the Medical Device Risk Management Standard was revised, but there was no change to the content of Clauses 1 through 9. Instead, the European Commission identified seven content deviations between the 14971 Standard and the requirements of three device directives for Europe. This seven-part blog series reviews each of these changes individually, and recommends changes to be made to your current risk management policies and procedure.

Risk reduction “As Far As Possible” (AFAP) vs. “As Low As Reasonably Practicable” (ALARP)

The third deviation is specific to the reduction of risk. Risk cannot always be eliminated by design solutions. This is why medical devices use protective measures (i.e., – alarms) and inform users of residual risks (i.e., – warnings and contraindications in an Instructions For Use (IFU). However, Essential Requirement 2 requires that risks be reduced “as far as possible.” Therefore, it is not acceptable to only reduce risks with cost-effective solutions. The “ALARP” concept has a legal interpretation which implies financial considerations. However, the European Directives will not allow financial considerations to override the Essential Requirements for safety and performance of medical devices. If risk controls are not implemented, the justification for this must be on another basis other than financial.

There are two acceptable reasons for not implementing certain risk controls. First, the risk control will not actually reduce additional risk. For example, if your device already has one alarm to identify a battery failure, a second alarm for the same failure will not actually reduce further risk. In fact, the redundant alarms are often distracting, and too many alarms will result in users ignoring them.

The second acceptable reason for not implementing a risk control is that there is a more effective risk control that cannot be simultaneously implemented. For example, there are multiple ways to anchor orthopedic implants to a bone. However, there is only enough real estate to have one fixation element at each location. If a femoral knee implant is already being anchored to the femur with metal posts and bone cement, you cannot also use bone screws at the same location on the femur to anchor the implants in place.

Example of Deviation #3-Risk Reduction

Annex D.8 in ISO 14971, recommends the ALARP concept in Clause 3.4 of the 14971 Standard. Therefore, the risk management standard is contradicting the MDD. This contradiction is the primary reason why medical device companies should discontinue the use of phthalates and latex for most medical devices. Even though these materials are inexpensive solutions to many engineering challenges presented by medical devices, these materials present risks that can be avoided by using more expensive materials that are not hazardous, and do not pose allergic reactions to a large percentage of the population. The use of safer materials is considered “state-of-the-art,” and these materials should be implemented if the residual risks, after implementation of the risk control (i.e., – use of a safer material) is not equal to, or greater than, the risk of the cheaper material.

Recommended Changes

Your company may have created a risk management procedure which includes a matrix for severity and probability. The matrix is probably color-coded to identify red cells as unacceptable risks, yellow cells that are ALARP and green cells that are acceptable. To comply with EN ISO 14971:2012, the “yellow zone” should not be labeled as ALARP. A short-term solution is to simply re-label these as high, medium and low risks. Unfortunately, renaming the categories of risk high, medium and low will not provide guidance as to whether the residual risk reduced “as far as possible.” chart dev 3 7 Deviations within EN ISO 14971:2012: Deviation #3 Risk Reduction

Resolution to this Deviation

As companies become aware of this deviation between the 14971 Standard and the Essential Requirements of the device directives, teams that are working on risk analysis, and people that are performing a gap analysis of their procedures will need to stop using a matrix like the example above. Instead of claiming that the residual risks are ALARP, your company will need to demonstrate that risks are reduced AFAP, by showing objective evidence that all possible risk control options were considered and implemented. Your procedure or work instruction for performing a risk control option analysis may currently state that you will apply your risk management policy to determine if additional risk controls need to be applied, or if the residual risks are ALARP.

This procedure or work instruction needs to be revised to specify that all risk control options will be implemented, unless the risk controls would not reduce risks further, or the risk controls are incompatible with other risk controls. Risk control options should never be ruled out due to cost.

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7 Deviations within EN ISO 14971:2012: Risk Evaluation Process

This 7 part blog series continues with the author reviewing deviation #2 of the EN ISO 14971: 2012 Standard, which is specific to the risk evaluation process. 
%name 7 Deviations within EN ISO 14971:2012: Risk Evaluation Process

In 2012, the European National (EN) version of the Medical Device Risk Management Standard was revised, but there was no change to the content of Clauses 1 through 9. Instead, the European Commission identified seven content deviations between the 14971 Standard and the requirements of three device directives for Europe. This seven-part blog series reviews each of these changes individually.

Discretionary Power of Manufacturers as to the Acceptability of Risks: The Risk Evaluation Process

The second deviation is specific to the risk evaluation process. The ISO 14971 Standard indicates in Annex D4 that the acceptability of risk is not specified by the Standard and must be determined by the manufacturer. In Clause 3.2 of the 14971 Standard, it states that, “Top management  shall: define and document the policy for determining criteria for risk acceptability.” This risk management policy is intended to indicate a threshold for risk acceptability. In Clause 5 of the 14971 Standard, the manufacturer is instructed to evaluate whether risks are acceptable using the risk management criteria defined in the risk management policy.

Essential requirements 1 and 2 require that risks be reduced as far as possible, and that all risks shall be included in a risk/benefit analysis—not just the risks above a certain threshold. Therefore, the requirement to establish a risk policy for the acceptability of risk directly contradicts the MDD.

Since the 2nd edition of the 14971 Standard was first issued (i.e., -2007), clients have been asking me how to establish acceptability criteria. For new devices, I recommend benchmarking the risks of the new device against existing devices. In other words, if the new device presents equal or lower risks than existing devices, then the risks of the new device are acceptable. For existing devices, I recommend performing a risk/benefit analysis, evaluating adverse events observed with the device against the benefits of using the device. Unfortunately, most companies choose arbitrary thresholds for acceptability of risk. Instead of relying upon benchmarking or risk/benefit analysis, companies will establish a policy that all risks must be below a quantitative value. For example, if the range of possible risks scores are from 1 to 1,000, all risks of 100 or less may be acceptable.

What is Acceptable?

In order to comply with the EN ISO 14971:2012 version of the risk management standard, you will need to implement risk controls for all risks, regardless of acceptability. However, you will also need to perform a risk/benefit analysis. The risk/benefit analysis should consider not only the benefits to patients and the risks of using the device, but the analysis should also consider relative benefits of using other devices.

The clinical evaluation report and the risk management report for the device should be based upon clinical evidence of the device for the intended use—including adverse events. For new devices that are evaluated based upon literature review of equivalent devices, Notified Bodies expect a Post-Market Clinical Follow-up (PMCF) study to be conducted in order to verify that the actual risk/benefit of the device is consistent with the conclusions of the clinical evaluation. In order to perform this analysis, a clinical expert is necessary to properly evaluate the risk/benefit ratio of the device, and to create a protocol for a PMCF study.

MEDDEV 2.12/2 rev 2, Post Market Clinical Follow-up Studies, indicates that the PMCF study protocol should indicate the study endpoints and the statistical considerations. In order to do this, your company will need to establish quantitative criteria for acceptability of the identified risks. Therefore, the existing 14971 Standard needs to be modified to clarify that risk acceptability criteria should be based upon clinical data, and evaluation of risks should be conducted at a later point in the risk management process (e.g., – as part of the overall risk/benefit analysis).

Impact of this Deviation

As your company becomes aware of the second deviation between the 14971 Standard and the Essential Requirements of the device directives, your risk management team will need to change the risk management process to clarify when risk acceptability should be evaluated, and the risk management policy should specify how acceptability should be determined.

The risk management process at your company will need to specify that implementation of risk controls is required for all risks—regardless of acceptability. You should also consider eliminating the evaluation of risk prior to implementation of risk controls. Instead, your company should base acceptability of risk solely upon the clinical risk/benefit analysis, and should involve the manufacturer’s medical officer in making this determination.

Finally, your risk management process should specify the need for PMCF studies in order to verify that actual clinical data supports the conclusion that the risk/benefit ratio is acceptable over the lifetime of the device.

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7 Deviations within EN ISO 14971:2012: Deviation #1

%name 7 Deviations within EN ISO 14971:2012: Deviation #1This blog reviews the treatment of the negligible risks deviation within the EN ISO 14971:2012 document.

In 2012, the European National (EN) version of the Medical Device Risk Management Standard was revised, but there was no change to the content of Clauses 1 through 9. Instead, the European Commission identified seven content deviations between the 14971 Standard and the requirements of three device directives for Europe. This seven-part blog series reviews each of these changes individually.

Treatment of Negligible Risks in ISO 14971

The first deviation is specific to the treatment of negligible risks. In Annex D8.2, the ISO 14971 Standard indicates that the manufacturer may discard negligible risks. However, Essential Requirements in the three device directives require that “All risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device.”

Common Misinterpretations

One of the most common mistakes is to confuse the concepts of a hazard, harm, and risk. Each of these terms is defined in the ISO 14971 Standard in section 2, but the common mistake is to think that the European Commission is saying that 100% of the hazards you identify need to be reduced as much as possible.

The intent is to require manufacturers to reduce risks, rather than hazards. The first step of the risk analysis process involves identifying hazards, but some of these hazards may never result in harm, due to risk controls that are inherent to the design your company has chosen. In addition, the severity of harm that a hazard may present could be so low that it may present no risk to the user or patient.

The best practice in risk management is to identify as many hazards as possible at the beginning of the risk analysis process, but then these hazards must be sorted into those hazards that will be analyzed for risk. One of the common phrases used in training is: “It is better to estimate the risk of 10% of 1,000 hazards than it is to estimate 50% of 100 hazards.”

If you follow the logic behind the phrase above, your team will need to estimate risk for 100 hazards, rather than 50 hazards. Your risk analysis team will also need to document the rationale behind categorization of hazards.

Categorizing Hazards

If a hazard is associated with adverse events in the Manufacturer and User Facility Device Experience (MAUDE) database (http://bit.ly/MAUDEDatabase) for your device or a similar device, then you need to ensure that the risk associated with that hazard is assessed and there are adequate risk controls. This is also true for any hazard associated with a customer complaint that your company anticipates. Any hazard that presents a high potential severity of harm should also be included in your risk analysis. However, if a hazard is completely eliminated by the design of your device, then you do not need to include it in the risk analysis.

I recommend writing a hazard identification report that includes all the hazards that were identified. This report should also categorize the hazard. You only need two categories: 1) hazards to be analyzed for risk, and 2) hazards that do not require risk analysis. You need a rationale for each risk that you do not perform risk analysis for, and you need traceability to risk controls and the risk/benefit analysis for each hazard that you do analyze.

Example of a Rationale for Not Analyzing the Risk of a Hazard:

About 8 years ago, the United States Food and Drug Administration (USFDA) issued an alert cautioning physicians to avoid the use of hemostatic agents near the spinal column, due to the potential hazard of paralysis caused by the swelling of a hemostatic agent as it absorbs blood. My employer, Z-Medica, quickly received many customer inquiries asking about the safety of QuikClot near the spinal column. I was able to quickly respond that there was zero risk of QuikClot causing paralysis, because that particular hemostatic agent did not swell. Instead of absorption, the product adsorbed blood and did not change in size or shape during the adsorption process.

Impact of this Deviation

As companies become aware of this deviation between the 14971 Standard and the Essential Requirements of the device directives, I believe teams that are working on risk analysis and people that are performing a gap analysis of their procedures will need to be more careful about which hazards are identified in their risk management reports. The burden of showing traceability from hazards to risk controls and risk/benefit analysis is substantial. Therefore, it is important to be systematic about how hazards are identified, and to provide a clear justification for any hazards that are not included in the risk analysis.

The common phrase that has been used in risk management training classes should be reconsidered in light of feedback from the European Commission. Maybe a better phrase would be: “It is better to estimate the risk of 10% of 200 hazards than it is to estimate 50% of 20 hazards. However, it is important to provide a clear justification for any hazards that are not included in the risk analysis.”

Upcoming Webinar – Implementing Risk Management Process Changes for EN ISO 14971:2012 – Instructor: Rob Packard, Medical Device Academy For more information– http://bit.ly/YjJqer

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Do I Need to Purchase the EN 14971:2012 version?

The author explains why it is not necessary to purchase the EN 14971: 2012 version, and provides an option to obtain information you may need.

What?!

I thought the current version was 2007?

No, there was a minor correction in 2009, but I haven’t heard about a 2012 version?

Great, now I have to buy another $300 Standard that will tell us nothing new.

STOP!

If the above conversation sounds familiar, hopefully, this blog will help.

Question 1: What is the current version?

Answer 1: EN 14971 was revised to 2012 on July 6, 2012. The previous 2009 version was withdrawn. The ISO version is not changing–just the EN version.

Question 2: What’s new in 2012?

Answer 2: Only the three Annexes related to harmonization with the three directives (MDD, AIMDD and IVDD) were updated. The content of the Standard itself has not changed.

Question 3: Do I need to buy this latest revision of the Standard…which really hasn’t changed since 2007?

Answer 3:  No…unless you still have the 2000 version. (just my personal opinion…not anyone else necessarily agrees)

And Here’s Why…

Historically, Annex ZA was the annex at the back of a Standard that would explain how it is harmonized with the European Directives. However, in 2009, Annex ZA was separated into ZA, ZB and ZC. Each of these Annexes explained how the current version of ISO 14971  (then ISO 14971:2007) differs from each of the three directives. In addition, there was a correction to Figure 1 (i.e., – arrow in the wrong location). NevilleClarke provided a good summary of these minor changes that occurred in 2009. The European Commission was concerned with some of the differences between the 2009 Standard and the Directives. Therefore, the Standard has been updated to clarify these differences.

There are seven technical deviations from the Standard that are required for compliance with the European Directives. Marcelo Antunes is an expert on Standards, and he accurately describes these deviations as “weird” in a discussion thread on Elsmar Cove’s Forum. The deviation that seems to have caught the most attention is the requirement to reduce ALL risk to “as low as possible” (ALAP) rather than to a level that to “as low as reasonably practicable” (ALARP concept). The “ALAP” acronym was a joke, but it wouldn’t be the first time that something like this stuck (i.e., – SWAG).

EN 14971: 2012 Version: An Alternative Approach

If you sleep with a label maker under your pillow, you should buy the new BS EN 14971:2012 version,  so you can ensure that you are staying in compliance with each of these 7 deviations, and that you have considered the implications fully in your procedure for Risk Management. However, if you are a practical person that prefers not to upset the entire development team, I recommend a different approach.

1. Download a copy of the relevant Directive from the Europa Website

2. Using Adobe, search the entire Directive for the word “risk”:

AIMDD = 24 times

MDD = 55 times

IVDD = 34 times

3. Systematically review where the word “risk” is used to determine if you need to make adjustments for your CE Marked products. If you already have a CE Mark, there should be no changes required to your risk management documents. Your procedures might need clarification to observe the requirements of the Directive when there is a difference between the Standard and the Directive.

Last Question: What is your Notified Body auditor going to do?

Final Answer: I’m not sure, because every auditor is a little different in their approach. However, as an instructor, I would teach an auditor to ask open ended questions, such as: “How did you determine if there is an impact upon your procedures and design documentation with regard to the updated Standard?” (i.e., – impact analysis). If the company provides an impact analysis and explains why the existing risk documentation and procedure should not change, I believe this meets the requirements for “equivalency with the State of the Art.”

Honestly, I haven’t seen one single company that was 100% in compliance with the “letter” of the Directives or the Standard. Sometimes, rationale thought must overcome political compromises and irrational behaviors.

On the other hand, it’s always possible that these 7 deviations, and the information on corrective action, will fundamentally change the way your company approaches risk management (I just dare you to bring it up at your next management review).

If you would like a second opinion, the Document Center’s Standard Forum says, “As you can see, this material is essential to conformance with the EN requirements and will make the purchase of the EN edition (BS EN ISO 14971 is the official English language edition) mandatory for medical device manufacturers certifying to the standard for sales in Europe.” FYI…Document Center’s Standard Forum sells Standards. You can buy this one from them for $324.

 

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ISO 14971 Risk Management Training: Lessons Learned

%name ISO 14971 Risk Management Training: Lessons Learned

The author discusses the four levels of the Learning Pyramid and lessons learned when he taught an ISO 14971 Risk Management course.

I am in Canada, it’s almost midnight, and my 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 related 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. 

4 Levels of the Learning Pyramid

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.”

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