Articles

Find all articles across all article series listed in reverse chronological order.

Sample size during Product Validation

After successful DV testing, the product moves into the PV phase. PV testing is conducted on units that are manufactured using the final production process, materials, and equipment. The purpose of PV is to validate that the production process can consistently produce units that meet the design specifications.

The sample size for PV is typically smaller than for DV, as indicated by the user input of around 10 samples. This is because the focus of PV is on the consistency and capability of the production process rather than the design itself.

These tests are crucial for products that incorporate complex mechanical, electrical, and chemical components, as they must perform reliably under a wide range of operating conditions and comply with stringent safety and environmental regulations.

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by Mike Sondalini Leave a Comment

Changing an EAM System for Operational Excellence Success

Any standard EAM system can be adapted to achieve Operational Excellence with the PWW EAM methodology.

Rather than going from policy to practice, Plant Wellness Way starts with how to create a healthy environment for parts microstructure when equipment is in-service. By focusing on creating healthy operating environments for components, machines, equipment, and plants, your operation will perform at world-class levels of reliability.

The standard range of Enterprise Asset Management models available will typically use an EAM Policy to decree the purposes of the EAM system. From this statement processes and practices necessary to achieve the EAM Policy aims are chosen. People will then aim to meet the policy requirements for their team or department without taking the flow on consequences into account. As a result, businesses will unintentionally create an EAM system that instils randomness and variability into the company. In this situation is it nearly impossible to create a system that achieves operational excellence success.

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by Greg Hutchins Leave a Comment

Medical Disruption

How Tech Can Turn Doctors into Clerical Workers
Title of New York Times Article

I bounced the above article among several of my doc buddies. The conversation went like: “You spent 10 years going to med school. Now, you push paper. And, BTW: you may be replaced by a robot. Huh. Yeah. Well. ….”

Not good for one of the most respected professions. But, an undisputable sign of concern among one of the most lucrative and respected professions during the COVID pandemic. It’s all about medical disruption.

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by Nancy Regan Leave a Comment

Let’s get into Failure Modes and Failure Effects

RCM Case Study Part 2/4

In today’s video, we dive deep into the critical steps of Reliability-Centered Maintenance (RCM) by exploring Failure Modes and Failure Effects as part of our ongoing dentist-themed mini RCM case study. This is Part 2 of a four-part series designed to help you understand and apply RCM principles through relatable, real-world examples. What You’ll Learn:

Failure Modes: Discover why detailed Failure Modes are essential and how they guide us to the right proactive maintenance and default strategies.
Failure Effects: Learn how to write comprehensive Failure Effects that depict the worst-case scenarios if no action is taken to manage the Failure Mode.

Case Study Highlight: We’ll look at the specific Failure Mode of bacteria accumulation that leads to cavities and track the progression from the earliest signs of decay to severe health consequences if left untreated. This detailed look will help you see why writing Failure Effects is crucial for assessing failure consequences

Key Takeaways: How to identify and write precise Failure Modes that lead to effective maintenance strategies. The importance of documenting Failure Effects to understand the full impact of asset failures.

This is a must-watch for anyone looking to refine their RCM skills and apply them practically. Be sure to tune in tomorrow for Part 3, where we’ll explore Failure Consequences and Preventive Maintenance!

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by Hemant Urdhwareshe Leave a Comment

How to use DFMEA form and Rating Guidelines

Dear friends, we are happy to release this FMEA Part-2 video. In this video, Hemant Urdhwareshe explains how to use the DFMEA form. He also explains briefly the guidelines for Severity, Occurrence and Detection rating as per AIAG VDA first edition and logic for setting priorities for action plan.

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by Michael Keer Leave a Comment

9: Validation

Article by Mike Freier

In the last blog post, we discussed how incorporating Agile principles can improve your hardware product development process. Not only will you be able to accelerate your schedule, but you can also develop higher quality products with lower costs and reduced risks. Furthermore, Agile frameworks and techniques can fit into your existing new product introduction (NPI) and stage gate process, so your high-level standard operating procedures do not have to change.

Once you have engineering and beta units in hand, validation and verification can begin. In this stage, engineering teams should test your product against the engineering design specification to verify that your product meets the performance, reliability, regulatory, manufacturing test, and safety goals.

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by Semion Gengrinovich Leave a Comment

Reliability Test can be Done in Parallel to Design Validation

Yes, reliability testing can be done in parallel with design validation (DV). This approach has both advantages and disadvantages, which are important to consider in the context of product development and testing. Pros of conducting reliability testing in parallel with design validation include time efficiency. Conducting reliability testing in parallel with (DV) can significantly reduce the overall time required for product development. By overlapping these processes, you can identify and address potential issues earlier, which can accelerate the time to market. Early detection of issues running reliability tests alongside (DV) allows for the early detection of design flaws or weaknesses. This can lead to quicker iterations and improvements, enhancing the overall quality and robustness.

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by Fred Schenkelberg Leave a Comment

Reliability is Not Metrics, It’s Decision Making

MTBF, KPIs, yield, return rate, warranty… bah!

We may use one or more of these when establishing product reliability goals. When tracking performance. When making decisions.

Goals, objectives, specifications, and requirements, are stand-ins for the customer’s experience with the product.

We’re not trying to reduce warranty expenses or shouldn’t be solely focused on just that measure. We need to focus on making decisions that allow our product deliver the expected reliability performance to the customer. [Read more…]

by Greg Hutchins Leave a Comment

Oil/Gas Evacuation Management: Leave No One Behind

Guest Post by Bill Pomfret (first posted on CERM ® RISK INSIGHTS – reposted here with permission)

Evacuation management is a necessary element of safety planning for oil and gas operations. It is critical to be prepared to evacuate personnel quickly and safely in the event of an emergency, as every second counts when lives are on the line. Evacuation drills and preparation exercises can be disruptive and time-consuming.

However, the overhead costs and lost productivity expended in preparation for emergency scenarios have become accepted as unavoidable costs of doing business. That’s because until now, there hasn’t been an efficient way to manage and improve evacuation drills while still adequately preparing team members for real emergencies. [Read more…]

by Mike Sondalini Leave a Comment

Useful Key Performance Indicators for Maintenance

A useful Maintenance Key Performance Indicator (KPI) drives reliability growth while guiding your choices for improving maintenance effectiveness and efficiency. A useful maintenance KPI lets you identify the issues causing your maintenance effects and helps you select the right strategy to either support or correct the actions producing the results. It is important that when you select a range of maintenance KPI you pick those that let you improve both equipment reliability and maintenance performance and not simply tell you that you have problems in your business.

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by Kirk Gray Leave a Comment

Thermal HALT

A Tool for the Discovery of Signal Integrity and Software Reliability I

Abstract—Failures in the execution of software can have many different causes. Errors in coding, incorrect sequence of software execution, and other factors result in software “bugs” that, when discovered, must be corrected for reliable system operation. However, this paper focuses on another cause of software failures: those that come from variations in the many tiers of component manufacturing and system assembly. This paper shows how applying thermal HALT on electronic circuits, and systems helps skew parametric performance at the circuit board and system levels and increase the probability of discovering marginal signal quality and integrity, which can lead to software operational failures.ssues

Update as of July 15, 2025: Kirk created a technical paper based on the material originally posted below. It has been updated, includes references, and has been reviewed.

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by James Reyes-Picknell Leave a Comment

Today’s Gremlin – Follow me blindly

Today’s Gremlin – “follow me blindly”, is one of the big reasons your equipment isn’t reliable. Manufacturers tell you what maintenance to perform and how to do it, then insist you follow their guidance by voiding warranties if you don’t. Those recommendations are full of inspections and replacements if you find any flaw – even normal wear and tear! They ask you to overhaul equipment, replacing all sorts of parts that you must buy from them. If you are in the parts business, as your manufacturers are, you can make a real killing! So, if I’m a manufacturer of industrial equipment, you must follow me blindly.

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by Larry George Leave a Comment

Estimate Reliability Functions Without Life Data

ASQC Reliability Review, Vol. 13, March 1993

This paper shows how to estimate field reliability functions from ships and returns. It offers to estimate field reliability functions from your data. It suggests how you can use these estimates to improve service and inventory management. [Links to Google Sheet and user guide follow the paper.]

You can estimate field reliability functions without life data. You don’t need to know each part’s time to failure. In fact, if you don’t know times to failures, you have to estimate field reliability functions from ships and returns, unless you have a sample of times to failures, and some of the sample failed.

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by George Williams Leave a Comment

Business Acumen: Driving Success in Maintenance and Reliability

In this video, we delve into the importance of business acumen for leaders at all levels. Business acumen is the ability to understand how an organization adds value, whether through its industry, structure, or processes. It’s crucial for setting direction and making informed decisions.

Learn how business acumen helps leaders articulate the nuances of their organization, navigate political and economic landscapes, and drive value in maintenance, operations, sanitation, and security. Discover how understanding your organization’s operations can lead to better business decisions and support across all levels.

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by Nancy Regan Leave a Comment

Dive into the Operating Context and Functions

RCM Case Study Part 1/4

Mini RCM Case Study: Creating a Reliability Strategy from My Trip to the Dentist

Welcome to Part 1 of our four-part mini-series, where we’ll create an RCM case study inspired by a relatable scenario: a trip to the dentist! In this series, you’ll learn the fundamentals of Reliability-Centered Maintenance (RCM) and apply them in a practical, engaging way.

In this video, we’ll cover:

1. Operating Context – Learn what it is, why it’s important, and how to draft it.

2. Functions – Discover how to define the reliability you need from your equipment by writing specific and measurable functions.

Meet Johnny Chomper—a 30-year-old professional whose teeth need to perform well to support his lifestyle. From biting and chewing to maintaining a confident smile, Johnny’s teeth are put to the test daily. We’ll draft his operating context and write a Primary Function that clearly defines the reliability required from his teeth. What You’ll Learn:

How to set the stage for an RCM analysis with a detailed operating context.
The importance of defining functions to establish reliability goals for your assets.
Step-by-step guidance on how to write a function that captures the desired reliability.

Stay tuned as we build this case study step-by-step, bringing RCM concepts to life in a way that’s easy to understand and apply. Don’t miss the next video, where we’ll dive into Failure Modes and Failure Effects!

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