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

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

2015 ESOS Guidelines Chapter 3 ? The ESOS Assessment

ESOS operates in tandem with the ISO 50001 (Energy Management) system that encourages continual improvement in the efficient use of energy. Any UK enterprise qualifying for ESOS that has current ISO 50001 certification on the compliance date by an approved body (and that covers the entire UK corporate group) may present this as evidence of having completed its ESOS assessment. It does however still require board-level certification, following which it must notify the Environment Agency accordingly.

The Alternate ESOS Route

In the absence of an ISO 50001 energy management certificate addressing comprehensive energy use, a qualifying UK enterprise must:

Measure Total Energy Consumption in either kWh or energy spend in pounds sterling, and across the entire operation including buildings, industrial processes and transport.
Identify Areas of Significant Energy Consumption that account for at least 90% of the total. The balance falls into a de minimis group that is officially too trivial to merit consideration.
Consider Available Routes to Compliance. These could include ISO 500001 part-certification, display energy certificates, green deal assessments, ESOS compliant energy audits, self-audits and independent assessments
Do an Internal Review to make sure that you have covered every area of significant consumption. This is an important strategic step to avoid the possibility of failing to comply completely.
Appoint an Approved Lead Assessor who may be internal or external to your enterprise, but must have ESOS approval. This person confirms you have met all ESOS requirements (unless you have no de minimis exceptions).
Obtain Internal Certification by one of more board-level directors. They must certify they are satisfied with the veracity of the reports. They must also confirm that the enterprise is compliant with the scheme.
Notify the Environment Agency of Compliance within the deadline using the online notification system at snapsurveys.com as soon as the enterprise believes is fully compliant.
Assemble your ESOS Evidential Pack and back it up in a safe place. Remember, it is your responsibility to provide proof of the above. Unearthing evidence a year later it not something to look forward to.

The ESOS assessment process is largely self-regulatory, although there are checks and balances in place including lead assessor and board-level certifications. As you work through what may seem to be a nuisance remember the primary objectives. These are saving money and reducing carbon emissions. Contact Ecovaro if we can assist in any way.

A Definitive List of the Business Benefits of Cloud Computing – Part 2

Improves cash flow

The capital investment you put into an on-premise IT infrastructure is normally based on a long-range forecast of what your highest computing demands will be. But what if, as they often do, the estimates turn out to be too high? Then you’ll have to bear with the huge depreciation cost or monthly amortisation of a grossly underutilised asset for the next couple of years. (more…)