posted 19 October 1999 12:07 PM               

Has anyone come across this issue in the past, and how should I handle this?

posted 19 October 1999 01:47 PM               

Severity may be the leading contributor to the RPN value. Severity measures the impact or outcome of an event. I have heard that Severity of 9 and 10 require corrective action, but nothing in regard a 7 rating. Either way, the difference may be meaningless as the outcome of an event may not be avoidable. It could be me, but I think someone is playing a numbers game. Perhaps only to see if you are prepared to defend your position.

In the interest of producing better products for consumers, organizations need to practice good "business ethics". A severity rating that is a 9 or 10 should challenge an organization to determine if their are ways they can reduce impact. For example, building secondary or tertiary safety features into a design or process (provided they exist) to prevent injury or death may be required. These additions would be perceived as "value added" as they protect the customer. In the nature of Continuous Improvement, I suppose an organization should explore reducing the severity of an event, even for lower ratings (8>). But where does an organization draw the line? Resources may be limited and reacting to every 7 rating may not be possible. Nor is it always necessary. Reducing Severity should be weighed against the value that is gained. Is the customer willing to pay the additional costs of secondary and tertiary safety/convenience features? Probably not. Often these additional items create waste in a product or process. The Customer does not want to pay for waste! Explore the lower cost improvements, those that can increase 'delight' within the customer base and are value added.

So what does the Customer consider waste? Ask them. Otherwise you run the risk of introducing waste to the system. Everyone loses under that premise.

Regards,

posted 19 October 1999 04:19 PM               

Thanks for your thoughts. I agree with you, totally.

We are a Magnet Wire manufacturer (insulated, copper wire) and the highest severity index we have is an 8 (non-hazordous but could result in 100% scrap). Therefore, we concentrated on improving our occurences and detectability. Most RPN's for the high severities are < 32. I felt like we were doing the right thing, and i truely beleive we are. Your comments seem to be very close to my idea of what the standard was asking.

posted 19 October 1999 05:03 PM               

I am glad to help. Keep in mind that sometimes Registrars, or auditors for that matter, challenge your decision making. This isn't necessarily to try to catch you doing "something wrong", but sometimes just to determine how you, or your organization, arrived at a conclusion. As Marc often points out here in the Cove, you must be prepared to defend yourself and, occasionally, fight the fight. I believe that they are mostly looking for how well you make decisions (are you considering things?).

Personally I find the FMEA process to be a very good Risk Analysis process. Considering the subjectivity of things in general, the FMEA guidelines to a fair job of creating continuity in the process. What you need to consider as an organization is that it won't necessarily fit every application as spelled out in the reference manual. There is a single line (often overlooked) where it instructs the reader to create similar criteria more meaningful for the organization. In theory, you may not denote a severity rating of 9 as a risk of injury to the user. But organizations should be warned that abrupt deviations from established "norms" may meet with heavy resistance and, perhaps, make it not worth pursuing.

Regards,