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Home » Blog

by Carl S. Carlson 2 Comments

FMEA Q & A – Medical Devices

FMEA Q & A – Medical Devices

3 Medical Device Questions

FMEA Q & A

In these series of questions, a reader asks about whether system FMEAs in the medical device industry should include human interactions, and the difference between system and application FMEAs.

“The art of proposing a question must be held of higher value than solving it.”  Georg Cantor

[Read more…]

Filed Under: Articles, Inside FMEA, on Tools & Techniques

by James Kovacevic 2 Comments

The Driver of Wrench Time: The Maintenance Planner / Scheduler

The Driver of Wrench Time: The Maintenance Planner / Scheduler

The Roles & Responsibilities of the Maintenance Planner / Scheduler

The Maintenance Planner / Scheduler is known as the coordinator of the maintenance department.  But what if they are unsure of the priorities of the department or business?  It has the potential to increase overtime, planned downtime and increase costs.  That is why this series continues with the Maintenance Planner / Scheduler.   With the Planner / Scheduler clear on their roles and responsibilities, the technicians can deliver the right amount of care. [Read more…]

Filed Under: Articles, Maintenance and Reliability, on Maintenance Reliability

by Adam Bahret Leave a Comment

The History of Reliability

The History of Reliability

If you had to section the history of reliability into only two periods I believe the dividing point would be around 1950.  The first section, stone age to 1950, the “Robust” era; 1950 to today, the “Margin” era.   In the robust, era reliability concerns were addressed by creating a design that was orders of magnitude stronger than required, “over-engineered”.  This protected against the variability of fabrication, use, and environment.  If it was made sloppily with low tolerances, it still worked;  Used for an unintended purpose, still worked; Left out in the snow, dropped in the river, run over by a horse, buried in the sand; still worked. [Read more…]

Filed Under: Apex Ridge, Articles, on Product Reliability

by Mike Sondalini 7 Comments

How Fluid Flows in Pipes

How Fluid Flows in Pipes

The Basics on How Fluid Flows in Pipes

A fluid is either a liquid or a gas. In industry, they are piped from storage to the point of use. Correct design and installation of the piping system minimises pressure loss and improves the behaviour of equipment and processes.

This article briefly explains what happens to fluids flowing through pipes. [Read more…]

Filed Under: Articles, on Maintenance Reliability, Plant Maintenance

by Greg Hutchins 7 Comments

Risk Assessment Challenges

Risk Assessment Challenges

We have conducted hundreds of risk assessments in a number of sectors from homeland security to pension funds to Parks and Recreation departments. We have a number of hard lessons learned. These are some common mistakes we have made and seen: [Read more…]

Filed Under: Articles, CERM® Risk Insights, on Risk & Safety Tagged With: Assessments

by Anne Meixner 1 Comment

How to Test Clocked Circuits

How to Test Clocked Circuits

What happens when you power up an electronics device with clocked circuits?

Well you have a clock running and you have clocked circuit elements, also known as sequential circuits.  Latches, registers, basically any “memory” element. What could interfere with testing?

Do you know the state of that “memory element” when you start?

Heck No!

That’s a problem. [Read more…]

Filed Under: Articles, on Tools & Techniques, Testing 1 2 3 Tagged With: Design For Test

by Fred Schenkelberg Leave a Comment

Determining Customer Reliability Requirements

Determining Customer Reliability Requirements

Determining What Customers Really Want Concerning Reliability

Customers want the benefits created by your product. They want the time savings, the reduced yield loss, they want simplicity, coolness, speed, etc.

Customers buy your product to solve a problem, they do not buy it to simply enjoy the features. The features have to do something of value. They have to provide a benefit.

If your product fails, the feature doesn’t work. Customers do not realize the benefit they expected.

In short, your customer wants your product to work as expected. When asked a customer will tell you they do not want to have product failures. [Read more…]

Filed Under: Articles, CRE Preparation Notes, Reliability Management Tagged With: Requirements

by Les Warrington Leave a Comment

Test Planning with Purpose

Test Planning with Purpose

Plan Your Reliability Testing with Intent

I wonder how many product tests have been undertaken and nothing has been done with the results? Maybe development activities have moved on before any results are available? Maybe the test results didn’t provide the answers that were needed? Maybe the test wasn’t focused on the critical issues. In other words, cost, time and resources were wasted.

I will present a better way to ensure value is delivered and test results are acted upon. [Read more…]

Filed Under: Achieving the Benefits of Reliability, Articles, on Product Reliability Tagged With: Reliability plan

by Dennis Craggs 1 Comment

Reliability Test Validation and Product Verification

Reliability Test Validation and Product Verification

Working with product engineers to develop a reliability test early in a program can be a satisfying experience. My interactions with the product engineers are the most fruitful when there is mutual respect. I ask the product engineer questions about his goals, the product features, the supplier, and rely on his product expertise. I like to examine prototype parts and review an engineering drawing or the circuit diagrams.

A good example was when a product engineer, let’s call him Jim,  approached me to develop a safety switch reliability test.

[Read more…]

Filed Under: Articles, Big Data & Analytics, on Tools & Techniques

by Doug Plucknette Leave a Comment

The Top 5 Signs of A Reliable Plant

The Top 5 Signs of A Reliable Plant

Having visited hundreds of manufacturing plants in the last 15 years, someone recently asked me if there were any traits the most reliable plants all had in common. I have listed below the top 5 signs of a reliable plant. [Read more…]

Filed Under: Articles, on Maintenance Reliability, RCM Blitz Tagged With: Maintenance program

by James Kovacevic 1 Comment

The Leader of Maintenance Excellence: The Maintenance Manager

The Leader of Maintenance Excellence: The Maintenance Manager

The maintenance manager is known as the leader of the maintenance department.  But what if they are unclear on where they are going or need to do?  It has the potential to derail the entire department.  That is why this series is going to start with the maintenance manager.   Once they are clear, the rest of the team can follow.

If you followed the steps in first post of the series, you would be ready to review the roles & responsibilities across the department.  This post takes the next step of breaking down the individual role of the maintenance manager to help you on that journey. [Read more…]

Filed Under: Articles, Maintenance and Reliability, on Maintenance Reliability

by Carl S. Carlson Leave a Comment

FMEA Success Factors – Part 2

FMEA Success Factors – Part 2

Six Essential Factors for FMEA Success

Problems and Solutions

Do you consider yourself an FMEA beginner or are you more experienced? Challenge yourself with these problems, and see how you do. One of the best ways to learn is by pondering actual application problems and seeing if you can solve them.

[Read more…]

Filed Under: Articles, Inside FMEA, on Tools & Techniques

by Mike Sondalini Leave a Comment

Capacitance Levels Probes

Capacitance Levels Probes

Capacitance level probes consist of a long rod or cable that protrude into a vessel and its contents. The instrument sets up an electric field between the probe and the tank wall using the contents of the tank as a dielectric (a nonconductor that allows an electric field to exist within itself). If the tank is non-metal, such as plastic or brick lined, two parallel rods are mounted in the level probe or a metal strip can be run on the outside of the tank. The electric field is set-up between the two probes or the probe and the metal strip. Figure 1 shows a simplified layout for a capacitance level probe. [Read more…]

Filed Under: Articles, on Maintenance Reliability, Plant Maintenance

by Greg Hutchins Leave a Comment

ISO 31000 as an Enterprise Risk Management Standard

ISO 31000 as an Enterprise Risk Management Standard

ISO 31000 is 23 pages long, but these pages provide an entry level Enterprise Risk Management (ERM) guideline.

Why is this important?

An organization develops ISO 31000 ERM capabilities to provide a structured, consistent, disciplined, and achievable approach to risk management that facilitates Risk Based Thinking throughout the organization. Risk Based Thinking is composed of 1. Risk based, problem solving (RB – PS) and 2. Risk based, decision making (RB –DM). Both RB – PS and RB – DM are the basis for all management and supervision. We discuss this in our new book: ISO 31000: Enterprise Risk Management.

Interestingly, we wrote a 230 page book packed with loads of information for a 23 page standard.   And oh by the way, we could have written another 200 pages. [Read more…]

Filed Under: Articles, CERM® Risk Insights, on Risk & Safety Tagged With: ISO 31000

by Adam Bahret 6 Comments

Mission Profile

Mission Profile

Mission profiles are fundamental to any reliability prediction being valid.  Without clearly defined environmental and use profiles there will be a long chain of inaccuracy that accumulates into significant errors within a product. coffee-on-keyboard

This is what occurs at the following stages, or tools, if the mission profile or environment profile changes after its completion. [Read more…]

Filed Under: Apex Ridge, Articles, on Product Reliability Tagged With: Environment and use profiling or characterization

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