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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What GDPR Means in Practice for Irish Business

The General Data Protection Regulation (GDPR) is a European directive aimed at ring-fencing consumer data against illegal or unnecessary access. There is nothing to discuss or debate with local politicians, or the Irish Data Protection Commissioner for that matter. As a European directive, it has over-riding power. To obtain an English version, please visit this link, and select ?EN? from the table of languages.

As you reach for your tea, coffee or Guinness after sighting it, you will be glad to know the Irish Data Protection Commissioner has the lead in turning this into business English we understand. The following diagram should assist you to obtain a quick overview of the process we all have to go through. In this article, we briefly describe what is inside Boxes 1 to 12. The regulation comes into force on 25 May 2018 so we have less than a year to get ready.

The 12 Essential Steps to Implementing the General Data Protection Act

1. Create awareness among your people of what is coming their way. The GDPR has given our regulator discretion to dish out fines up to ?20,000,000 (or 4% of total annual global turnover, whichever is greater) so there is determination to make this happen.

2. Become accountable by understanding the consumer data you hold. Why are you retaining it, how did you obtain it, and why did you originally collect it. Now you know it is there, how much longer will you still need it? How secure is it in your hands, have you ever shared it?

3. Open a communication channel with your staff, your customers, and anyone else using the data. Share how you feel about how accountable you have been with the information in the past. Explain how you plan to comply with the GDPR in future, and what needs to change.

4. Understand the personal privacy entitlement of the subjects of the information. They have rights to access it, correct mistakes, remove information, restrict its use, decline direct marketing, and copy it to their own files. What needs to change in your systems to assure these rights?

5. Issue a policy for allowing consumers access to their information you hold. You must process requests within a month, and you may not charge for the service unless your cost is excessive. You may decline unfounded or excessive demands within your policy guidelines.

6. Adapt to the requirement that you must have a legal basis for everything you do with, and to consumer data. You need to be in a position to justify your actions to the Irish Data Protection Commissioner in the event of a complaint. Having a legitimate interest is no longer sufficient.

7. Ensure that consumer consent to collect, use, and distribute their data is ?freely given, specific, informed, and unambiguous.? From 25 May 2018 onward, this consent will be your only ground to do so. You cannot force consent. Your benchmark becomes what the GDPR says.

8. Issue rules for managing data of underage subjects. This is currently under review and we are awaiting results. Put systems in place to verify age. Set triggers for where guardians must give consent. Make sure age is verifiable. Use language young people understand.

9. Introduce a culture of openness and honesty, whereby breaches of the GDPR are detected, reported, investigated, and resolved. You will have a duty to file a GDPR report with the Data Protection Commissioner within 72 hours, thus it is important to fast track the process.

10. Introduce a policy of conducting a privacy assessment before taking new initiatives. The GDPR calls for ?privacy by deign?, and we need to engineer it in. This may be the right time to appoint a data controller in your company, and start implementing the GDPR while you have time.

11. You may also need to appoint a data protection officer depending on the size of your business. Alternatively, you need to add managing data protection compliance to an employee?s duties, or appoint an external data-protection compliance consultant.

12. Finally, and you will be glad to know this is the end of the list, the GDPR has an international flavour in that multinational organisations will report into the EU Lead Supervisory Authority. This will manage the process centrally while consulting national data authorities.

The GDPR is a project we all need to complete. If we are out of line, it is in our interests to get things straightened out. Once everything is in place, the task should not be too onerous. Getting there could be the pain.

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Large scale corporate transformation

Large scale corporate transformation are the necessary actions required to increase performance in an organisation. It leads to greater performance results and greater organisational growth. It is a lasting change and can range from getting new leaders to combining the functions of different departments. It can also involve the introduction of a new phase in the life of an organisation. Large scale corporate transformation can be measured using three variables. The first variable involves determining how deep the change penetrates to all levels of the organisation. The second variable measures how entrenched it becomes in the organisation while the third measure determines the percentage of the organisation covered in the change.

Corporate transformation is essential for a company that seeks to have a greater impact and a longer life in its business sector. The process requires time and resources. The whole establishment needs to support it for success. Not only does the top management need to back it, but stockholders and staff members also need to buy the idea. This is because when the process of corporate transformation hits a barrier, it will take the entire organisation to keep it on course and complete the process. Without the support of everyone, most organisations will not complete the process.

Business transformation in recent times has begun to combine finance, HR and IT departments into one functioning piece of an organisation. This has resulted in leaner, faster, and more efficient corporate entities that produce high results and has a greater impact in its overall functioning. These three key departments are the backbone of any organisation, and the combination of the three creates an efficient organisation that translates into high performance results.

One crucial aspect of large scale corporate transformation is IT transformation, which entails the entire overhaul of any organisation’s technology systems. It adopts a more efficient platform that enhances its overall operation. IT transformation involves the use of Service Oriented Architecture (SOA) and open systems. This process is the revamping of the existing technology used to support the organisation and is critical for aligning the business functions to the mission of the organization. It touches on the current hardware and software and how they can best be improved upon for greater results. This process is necessary in the entire business transformation.

The question that needs to be addressed is how any organisation can make this process successful. First, it requires the understanding that it is not just a goal to be achieved, but a new way of thinking embraced by the entire organisation. Secondly, the leadership in place needs to be fully involved and dedicated to the process and to realise that it takes time and effort to complete such a mission. There also needs to be flexibility and adaptability in order to learn from mistakes and keep moving forward. Constant communication is also critical to ensure that everyone involved understands the current stage and the next steps to be done. Change is the only constant and is necessary for progress and success.

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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