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.

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Can you do away with the Project Initiation Meeting?

Project initiation meetings are often skipped to fast-track projects. Once a sponsor is found, organisations go straight to project planning and execution. But based on our own experience, holding a project initiation meeting can actually eliminate many issues that may crop up in the future and hence may speed things up instead in the long run.

It is in the project initiation meeting where your project objectives and scope are clarified and all stakeholders are brought to the same page. Project sponsors and stakeholders will have to know in a nutshell what is needed from them, what the possible risks are, what different resources are required, and so on. So that, when it’s time to proceed to the next phase, everyone is already in-sync.

So what are taken up in such a meeting? Perhaps an actual example can help. Sometime in the past, we set out to work on an eCommerce website project. After conducting the project initiation meeting, these were some of the things we were able to accomplish:

  • Identified deliverables e.g. site design, interface to payment system, etc.
  • Come up with the project phases
  • Agreed what should be in and out of scope
  • Defined the acceptance test criteria
  • Identified possible risks
  • Identified the possible training and documentation work needed
  • Established whether any analysis was required, e.g. as with regards to payment interfaces
  • Formulated disaster recovery plans
  • Defined roles and responsibilities
  • Drafted timelines and due dates

Aren’t these covered in project planning? If the project is a big one, the answer is no. In a large project, project planning is a much more exhaustive activity. In a project initiation meeting, only the basic framework is defined.

Some questions may still remain unanswered after a project initiation meeting, but at least you already know what answers you need to look for. In the example we gave earlier, we left the meeting knowing that we needed:

  • a list of all necessary hardware to estimate the costs
  • to identify possible dependencies we might have with third parties
  • to identify what software had to be bought and what skills we needed to hire

When it was time to proceed to project planning, everyone involved already knew what direction we were taking. In effect, by not skipping the project initiation meeting, we were able to avoid many potential obstacles.

Six Sigma

Six Sigma has received much attention worldwide as a management strategy that is said to have brought about huge improvements and financial gains for such big-name companies as Allied Signal, General Electric (GE) and Motorola.

If you want to give your business the chance to attain the same resounding success, Six Sigma could be the method that will steer you towards that direction.

What is Six Sigma?

So what really is it? Six Sigma is a business management tool that was developed using the most effective quality improvement techniques from the last six decades. Basing its approach on discipline, verifiable data, and statistical calculations, Six Sigma aims to identify the causes of defects and eliminate them, thereby resulting in near-perfect products that meet or exceed customer’s satisfaction.

The core concept behind the Six Sigma method is that if an organisation can quantify the number of “defects” there are in a particular process, improvement activities can be implemented to eliminate them, and get as close to a “zero defects” scenario as possible. Defect here is defined as any process output that fails to meet customer specifications.

Six Sigma is also unique from other programs in that it calls for the creation of a special infrastructure of people within the organisation (“Champions“, “Black Belts“, “Green Belts“) who are to be expert in the methods.

Six Sigma Methodologies

When implementing Six Sigma projects, two methodologies are often employed. Although each method uses five phases each, these two are distinguished from each other using 5-letter acronyms and their specific uses.

DMAIC ? is the project methodology used to improve processes and maximise productivity of current business practices. The 5 letters stand for:

  • D ? Define (the problem)
  • M ? Measure (the main factors of the existing process)
  • A ??Analyse?(the information gathered to deter mine the causes of defects)
  • I ? Improve (the current process based on the analysis)
  • C ? Control (all succeeding processes so as to minimise additional defects)

DMADV – is the method most suitable if your business is looking to create new products or designs. The acronym stands for:

  • D ? Define (product goals as the consumer market demands)
  • M ? Measure (and identify product capabilities and risks)
  • A ??Analyse?(to create the best possible design)
  • D ? Design (the product or process details)
  • V ? Verify (the design)

How does Six Sigma differ from other quality programs?

If you think that Six Sigma is just another one of those business strategies that produce more hype than actual results, think again. Six Sigma uses three key concepts that sets it apart from other business management methods.

  • It is strictly a data-driven approach, where assumptions and guesswork do not figure in the decision making.
  • It focuses on achieving quantifiable financial results ? the bottom line ($) ? as much as giving emphasis on customer satisfaction.
  • It requires strong management leadership, while at the same time creating a role for every individual in the organisation.

Is Six Sigma right for your business?

While many other organisations such as Sony, Nokia, American Express, Xerox, Boeing, Kodak, Sun Micro-systems and many other blue chip companies have followed suit in adopting Six Sigma, the truth is, any company — whether you have a large manufacturing corporation, or a small business specialising in customer service.

Certainly, there is a lot more to Six Sigma than what you can probably absorb in one sitting or reading.

With our wide range of business management consultancy services, we can help you understand the Six Sigma method in the context of your business. We can also help you establish your improvement goals, set up your program, and train your own team of “champions” who can lead in implementing your Six Sigma goals.

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Is the GDPR Good or Bad News for Business

The European Union?s General Data Protection Act (GDPR) is a new data authority coming into force on 25 May 2018. It replaces the current Data Protection Directive 95/46/EC, while extending the remit to include the export of personal data outside the EU. It aims to give EU citizens and residents living there more control over their personal information. It also hopes to make regulatory compliance simpler for participating businesses.

The Broad Implications for Business
The GDPR puts another layer of accountability on businesses falling within its remit. It requires them to implement ?comprehensive but proportionate governance measures? including recording how they make decisions. The long-term goal is to reduce privacy infringements. In the short run, businesses without good governance may find themselves writing new policies and procedures.

Article 5 of the European Union?s General Data Protection Act lays down the following guidelines for managing personal data. This shall be ?
? Processed transparently, fairly, and lawfully
? Acquired for specific, legitimate purposes only
? Adequate, relevant and limited to essentials
? Not used for any other, incompatible purpose
? However it may be archived in the public interest
? Kept up to date with all inaccuracies corrected
? Ring-fenced when the information becomes irrelevant
? Adequately protected against unauthorised access
? Stored in a way that prevents accidental loss
Furthermore, affected businesses shall appoint a ?controller responsible for, and able to demonstrate, compliance with the principles.?

Implementing Accountability and Governance
The UK Information Commissioner?s Office has issued guidelines regarding provisions to assure governance and accountability. These are along the lines of the ?don’t tell me, show me? management approach the office has generally been following. In summary form, a business, and its controller must:
? Implement measures that assist it to ensure demonstrated compliance
? Maintain suitable, relevant records of personal data processing activities
? Appoint a dedicated data protection officer if scale makes this appropriate
? Implement technologies that ensure data protection by design
? Conduct data protection assessments and respond to results timeously

Implementing the General Data Protection Act in Ireland
The Irish Data Protection Commissioner has decided it is unnecessary to incorporate the GDPR into Irish law, since EU regulations have direct effect. The office of the Commissioner is working in tandem with data practitioners, and industry and professional bodies to raise awareness in business through 2017. It has produced a document detailing what it considers the essentials for business compliance. Briefly, these pre-requisites are:
? Ensure awareness among key personnel, and make sure they incorporate the GDPR into their planning
? Conduct an early assessment of quality management gaps, and budget for additional resources needed
? Do an audit of personal data held, to determine the origin, the necessity to hold it, and with whom shared
? Inform internal and external stakeholders of the current status, and your future plans to implement the GDPR
? Examine current procedures in the light of the new directive. Could you ?survive? a challenge from a data subject?
? Determine how you will process requests for access to the data in the future from within and outside your organization
? Assess how you currently obtain customer consent to store their data. Is this “freely given, specific, informed and unambiguous”?
? Find how you handle information from underage people. Do you have systems to verify ages and obtain guardian consent?
? Implement procedures to detect, investigate, and report data breaches to the Data Protection Commissioner within 72 hours
? Implement a culture of always assessing the effect on individual privacy before starting new initiatives

So Is the GDPR Good or Bad for Business
The GDPR should be good news for business customers. Their personal data will be more secure, and they should see their rate of spam marketing come down. The GDPR is also good news for businesses currently investing resources to protect their clients? interests. It could however, be bad news for businesses that have not been focussing on these matters. They may have a high mountain to climb to come in line with the GDPR.
Disclaimer: This article is for information only and not intended as a comprehensive guide.

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