Failure Mode and Effects Analysis

Any business in the manufacturing industry would know that anything can happen in the development stages of the product. And while you can certainly learn from each of these failures and improve the process the next time around, doing so would entail a lot of time and money.
A widely-used procedure in operations management utilised to identify and analyse potential reliability problems while still in the early stages of production is the Failure Mode and Effects Analysis (FMEA).

FMEAs help us focus on and understand the impact of possible process or product risks.

The FMEA method for quality is based largely on the traditional practice of achieving product reliability through comprehensive testing and using techniques such as probabilistic reliability modelling. To give us a better understanding of the process, let’s break it down to its two basic components ? the failure mode and the effects analysis.

Failure mode is defined as the means by which something may fail. It essentially answers the question “What could go wrong?” Failure modes are the potential flaws in a process or product that could have an impact on the end user – the customer.

Effects analysis, on the other hand, is the process by which the consequences of these failures are studied.

With the two aspects taken together, the FMEA can help:

Discover the possible risks that can come with a product or process;
Plan out courses of action to counter these risks, particularly, those with the highest potential impact; and
Monitor the action plan results, with emphasis on how risk was reduced.

Find out more about our Quality Assurance services in the following pages:

Check our similar posts

Becoming Nimble the Agile Project Management Way

In dictionary terms, ?agile? means ?able to move quickly and easily?. In project management terms, the definition is ?project management characterized by division of tasks into short work phases called ?sprints?, with frequent reassessments and adaptation of plans?. This technique is popular in software development but is also useful when rolling out other projects.

Managing the Seven Agile Development Phases

Stage 1: Vision. Define the software product in terms of how it will support the company vision and strategy, and what value it will provide the user. Customer satisfaction is of paramount value including accommodating user requirement changes.
Stage 2: Product Roadmap. Appoint a product owner responsible for liaising with the customer, business stakeholders and the development team. Task the owner with writing a high-level product description, creating a loose time frame and estimating effort for each phase.
Stage 3: Release Plan. Agile always looks ahead towards the benefits that will flow. Once agreed, the Product Road-map becomes the target deadline for delivery. With Vision, Road Map and Release Plan in place the next stage is to divide the project into manageable chunks, which may be parallel or serial.
Stage 4: Sprint Plans. Manage each of these phases as individual ?sprints?, with emphasis on speed and meeting targets. Before the development team starts working, make sure it agrees a common goal, identifies requirements and lists the tasks it will perform.
Stage 5: Daily Meetings. Meet with the development team each morning for a 15-minute review. Discuss what happened yesterday, identify and celebrate progress, and find a way to resolve or work around roadblocks. The goal is to get to alpha phase quickly. Nice-to-haves can be part of subsequent upgrades.
Stage 6: Sprint Review. When the phase of the project is complete, facilitate a sprint review with the team to confirm this. Invite the customer, business stakeholders and development team to a presentation where you demonstrate the project/ project phase that is implemented.
Stage 7: Sprint Retrospective. Call the team together again (the next day if possible) for a project review to discuss lessons learned. Focus on achievements and how to do even better next time. Document and implement process changes.

The Seven Agile Development Phases ? Conclusions and Thoughts

The Agile method is an excellent way of motivating project teams, achieving goals and building result-based communities. It is however, not a static system. The product owner must conduct regular, separate reviews with the customer too.

Disadvantages of Spreadsheets – Obstacles to Compliance in the Healthcare Industry

Most of the regulatory compliance issues we talked about concerning spreadsheets have been related to financial data. But there are other kinds of data that are stored in spreadsheets which may also cause regulatory problems in the future.

In the US, a legislation known as HIPAA or Health Insurance Portability and Accountability Act is changing the way health care establishments and practitioners handle patient records. The HIPAA Privacy Rule is aimed at protecting the privacy of individually identifiable health information a.k.a. protected health information (PHI).

Examples of PHI include common identifiers like a patient’s name, address, Social Security Number, and so on, which can be used to identify the patient. HIPAA covers a wide range of health care organisations and service providers, including: health plan payers, health care clearing houses, hospitals, doctors, dentists, etc.

To protect the confidentiality, integrity, and availability of PHI, covered entities are required to implement technical policies such as access controls, authentication, and audit controls. These can easily be implemented on server-based systems.

Sad to say, many health care organisations who have started storing data electronically still rely on spreadsheet-based systems. Those policies are hard to implement in spreadsheet-based systems, where files are handled by end-users who are overloaded with their main line of work (i.e. health care) and have very little concern for data security.

In some of these systems, spreadsheet files containing PHI may have multiple versions in different workstations. Chances are, none of these files have any access control or user authentication mechanism whatsoever. Thus, changes can easily be made without proper documentation as to who carried out the changes.

And because the files are normally easily accessible, unauthorised disclosures – whether done intentionally or accidentally – will always be a lingering threat. Remember that HIPAA covered entities who are caught disclosing PHI can be fined from $50,000 up to $500,000 plus jail time.

But that’s not all. Through the HITECH Act of 2009, business associates of covered entities will now have to comply with HIPAA standards as well. Business associates are those companies who are performing functions and services for covered entities.

Examples of business associates are accounting firms, law firms, consultants, and so on. They automatically need to comply with the standards the moment they too deal with PHI.

More Spreadsheet Blogs

Spreadsheet Risks in Banks

Top 10 Disadvantages of Spreadsheets

Disadvantages of Spreadsheets – obstacles to compliance in the Healthcare Industry

How Internal Auditors can win the War against Spreadsheet Fraud

Spreadsheet Reporting – No Room in your company in an age of Business Intelligence

Still looking for a Way to Consolidate Excel Spreadsheets?

Disadvantages of Spreadsheets

Spreadsheet woes – ill equipped for an Agile Business Environment

Spreadsheet Fraud

Spreadsheet Woes – Limited features for easy adoption of a control framework

Spreadsheet woes – Burden in SOX Compliance and other Regulations

Spreadsheet Risk Issues

Server Application Solutions – Don’t let Spreadsheets hold your Business back

Why Spreadsheets can send the pillars of Solvency II crashing down

amazon.co.uk

amazon.com

Saving Energy Step 5 – Bringing it together

We hope you have been enjoying our series of short posts regarding saving energy, so what we use we can sustain. We have tried to make a dry subject interesting. After you read this post please comment, and tell us how it went. We are in the environment together. As the man who wrote ?No Man is an Island? said, ?if a clod be washed away somewhere by the sea, Europe is the less? and Europe was his entire world.

The 4 Steps we wrote about previously have a multiplier effect when we harness them together

Having a management system diffuses office politics and pins accountability in a way that not even a worm could wriggle
This defines the boundaries for senior managers and empowers them to implement practical improvements with confidence
The results feed back into lower energy bills: this convinces the organisation that more is possible
This dream filters through all levels of the organisation, as a natural team forms to make work and home a better place.

None of this would be possible without measuring energy consumption throughout the process, converting this into meaningful analytics, and playing ?what-if? scenarios against each other to determine where to start.

The 5^th Step to Energy Saving that brings the other four together can double the individual benefits as innovative power flows between them. The monetary savings are impressive and provide capital to go even further. Why not allow us to help you manage what we measure together.

ecoVaro turns your numbers into meaningful analytics, makes suggestions, and stays with you so we can quantify your savings as you make them. We should talk about this soon.

Contact Us

(+353)(0)1-443-3807 – IRL
(+44)(0)20-7193-9751 – UK