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:

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FUJIFILM Cracks the Energy Code

FUJIFILM was in trouble at its Dayton, Tennessee plant in 2008 where it produced a variety of speciality chemicals for industrial use. Compressed-air breakdowns were having knock-on effects. The company decided it was time to measure what was happening and solve the problem. It hoped to improve reliability, cut down maintenance, and eliminate relying on nitrogen for back-up (unless the materials were flammable).

The company tentatively identified three root causes. These were (a) insufficient system knowledge within maintenance, (b) weak spare part supply chain, and (c) generic imbalances including overstated demand and underutilised supply. The maintenance manager asked the U.S. Department of Energy to assist with a comprehensive audit of the compressed air system.

The team began on the demand side by attaching flow meters to each of several compressors for five days. They noticed that – while the equipment was set to deliver 120 psi actual delivery was 75% of this or less. They found that demand was cyclical depending on the production phase. Most importantly, they determined that only one compressor would be necessary once they eliminated the leaks in the system and upgraded short-term storage capacity.

The project team formulated a three-stage plan. Their first step would be to increase storage capacity to accommodate peak demand; the second would be to fix the leaks, and the third to source a larger compressor and associated gear from a sister plant the parent company was phasing out. Viewed overall, this provided four specific goals.

  • Improve reliability with greater redundancy
  • Bring down system maintenance costs
  • Cut down plant energy consumption
  • Eliminate nitrogen as a fall-back resource

They reconfigured the equipment in terms of lowest practical maintenance cost, and moved the redundant compressors to stations where they could easily couple as back-ups. Then they implemented an online leak detection and repair program. Finally, they set the replacement compressor to 98 psi, after they determined this delivered the optimum balance between productivity and operating cost.

Since 2008, FUJIFILM has saved 1.2 million kilowatt hours of energy while virtually eliminating compressor system breakdowns. The single compressor is operating at relatively low pressure with attendant benefits to other equipment. It is worth noting that the key to the door was measuring compressed air flow at various points in the system.

ecoVaro specialises in analysing data like this on any energy type.?

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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.

 

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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

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8 Reasons why you Need to Undertake Technical and Application Assessments

Are your information assets enabling you to operate more cost-effectively or are they just drawing in more risks than you are actually aware of? Obviously, you now need to get a better picture of those assets to see if your IT investments are giving you the benefits you were expecting and to help you identify areas where improvements should be made.

The best way to get the answers to those questions is through technical and application assessments. In this post, we?ll identify 8 good reasons why it is now imperative to undertake such assessments.

1. Address known issues – Perhaps the most common reason that drives companies to undertake a technology/application assessment is to identify the causes of existing issues such as those related to data accessibility, hardware and software scalability, and performance.

2. Cut down liabilities and risks – Unless you know what and where the risks are, there is no way you can implement an appropriate risk mitigation strategy. A technology and application assessment will enable you to thoroughly test and examine your information systems to see where your business-critical areas and points of failure are and subsequently allow you to act on them.

3. Discover emerging risks – Some risks may not yet be as threatening as others. But it would certainly be reassuring to be aware if any exist. That way, you can either nip them in the bud or keep them monitored.

4. Comply with regulations – Regulations like SOX require you to establish adequate internal controls to achieve compliance. Other regulations call for the protection of personally identifiable information. Assessments will help you pinpoint processes that lack controls, identify data that need protection, and areas that don’t meet regulatory requirements. This will enable you to act accordingly and keep your company away from tedious, time-consuming and costly sanctions.

5. Enhance performance – Poor performance is not always caused by an ageing hardware or an overloaded infrastructure. Sometimes, the culprits are: unsuitable configuration settings, inappropriate security policies, or misplaced business logic. A well-executed assessment can provide enough information that would lead to a more cost-effective action plan and help you avoid an expensive but useless purchase.

6. Improve interoperability – Disparate technologies working completely separate from each other may be preventing you from realising the maximum potential of your entire IT ecosystem. If you can examine your IT systems, you may be able to discover ways to make them interoperate and in turn harness untapped capabilities of already existing assets.

7. Ensure alignment of IT with business goals – An important factor in achieving IT governance is the proper alignment of IT with business goals. IT processes need to be assessed regularly to ensure that this alignment continues to exist. If it does not, then necessary adjustments can be made.

8. Provide assurance to customers and investors – Escalating cases of data breaches and identity theft are making customers and investors more conscious with a company?s capability of preserving the confidentiality of sensitive information. By conducting regular assessments, you can show your customers and investors concrete steps for keeping sensitive information confidential.

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