What’s Your Excuse…

…for not starting ISO 2015?

  • I don’t know where to start ISO 2015 implementation?ISO_2015_Excuses
  • How do I gain management support and prepare my ISO 2015 project?
  • What are my first steps in ISO 2015 implementation?
  • How do I convince my company peers to follow a new ISO 2015 process?
  • Can I speed up the ISO 2015 implementation?
  • The processes are in place, how do I prepare for ISO 2015 certification?
  • I’m worried about maintaining the business processes once ISO 2015 is operational?

Contact me to find out how I can help you solve these challenges.

920-841-3478

Steve@TheRightApproachConsulting.com

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The Good, the Bad and the Ugly…

Beginning as a part of his newscasts during the Second World War and then premiering as its own series on the ABC Radio Networks on May 10, 1976, Paul Harvey’s “The Rest of the Story” consisted of very short stories presented as little-known or forgotten facts on a variety of subjects that in the end turned out to be about a well-known person.

As a change of pace from my typical posts, and to honor the legacy of my good friend, I have decided to occasionally post “The Good, the Bad and the Ugly”, which carries on in somewhat of the same tradition. I hope you enjoy the first installment.

The Ugly: Nolan Bushnell could have owned one-third of AppleTROTS Nolan Bushnell

In 1976, Atari founder Nolan Bushnell turned down the opportunity to invest $50,000 in seed money in Apple. At Atari, Bushnell was one of Steve Jobs’ first bosses. Had Bushnell said yes, he would have owned a third of Apple, a company that is today valued at about $535 billion.

Contact me for a free phone consultation and for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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Getting to Know Your Management Rep Pt. 3

Finishing up with the 3rd and last major role of the Quality Management Representative:

Role 3. Promote customer requirements. The last responsibility is to ensure that people are aware of customer requirements throughout the organization. Since one of the main thrusts of an ISO 9001 quality management system is customer satisfaction, it is vital that all employees understand what the customer needs, and how they are able to affect how well the company satisfies these needs. Customer focus is one of the main Seven Quality Management Principles behind ISO 9001 requirements, and as such needs to have an advocate in the company.

Hand drawing Customer concept with marker on transparent wipe board.

By being the “voice of the customer” in the organization, the quality management representative can make great strides in how satisfied customers are. If the company implemented a quality management system to improve customer satisfaction, it only makes sense that someone is responsible to promote the customer needs in the company, and the management rep is the leader of this initiative.

External liaison. The additional note to paragraph 5.5.2 of the ISO 9001 standard states that the “responsibilities can include liaising with external parties on matters relating to the QMS.” This is where the quality management representative becomes the one name that the certification body can call, or the customer can contact with complaints. It is often these optional responsibilities that are seen as the main role of the management rep, but in fact these could be done by one of many other people without affecting the effectiveness and success of the QMS.

Utilize your quality management representative

As I hope you can see, utilizing your quality management rep as the leader of the QMS is the best way to ensure the quality management system is effective, efficient and improves over time. In order for this to work well it is important to choose the best person for this job, just like any other management position in the company, because choosing the wrong person could mean that your QMS implementation is at best sub-optimal, and at worst a complete failure and waste of resources.

Contact me for a free phone consultation and for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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Getting to Know Your Management Rep Pt. 2

Continuing from the last Pt. 1 post with the 2nd major role of the Quality Management Representative:

Role 2. Reporting on QMS performance. The management representative has a second responsibility to report to top management on how well, or poorly, the QMS is performing. Identifying any needs for improvement to top management is also part of this responsibility. As has already been said, top management needs to be fully supportive of the ISO 9001 quality management system implementation if it is going to provide true benefit to the company.Mgmtrep_pt2 In order for this to function, there needs to be a point of focus for top management to use when reviewing the resource needs of the QMS, and how best to support the improvement needed. Being the voice of the QMS for top management can be the critical factor in a QMS providing return on investment for the company, or not.

The management rep will gather this sort of information from the monitoring and measurement activities in the company (see Monitoring and Measurement: The basis for evidence-based decisions) and when the company uses a management review meeting this is the sort of information that is presented, see How to make Management Review more useful in the QMS.

The next blog will cover Role 3. Promote customer requirements

Contact me for a free phone consultation and for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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Getting to Know Your Management Rep Pt. 1

ISO 9001, ISO 13485 & AS9100 all call out a requirement to have a member of management assigned as the quality management representative (It should be noted that ISO 9001: 2015 has removed this requirement, however, someone(s) will still need to fulfill the responsibilities). It is important that you document in some way (appointment letter, management review minutes) that top managemMgmtrep_pt1ent has appointed this person to the position. I have previously published “Steve’s Particular Set of Skills” for this position, and now I will review the responsibilities placed on this individual.

Having the right person for this position can make or break your QMS (quality management system), and to help you understand the role and how it can fit into your existing organization. While this role is often taken on by the quality manager, it is not a requirement that this be the case; any member of management can be assigned these responsibilities. The Management Rep is the face of the QMS and often has extensive face time with your customers

Major Responsibilities of the Management Representative

Role 1. QMS Process Maintenance. The standard asks that the management representative ensure that the QMS processes are established, implemented and maintained to comply with the standard. This may involve review of internal audits, discussion with process owners, and review of the processes and procedures to ensure they are properly maintained. Companies that try to manage this through a “divide and conquer” process owner effort generally fail with no single person having responsibility and authority. By having a focal point for the overall processes, the management rep can not only ensure that each process is functioning, but that the interaction of the processes is maintained. By doing this, the interactions can then start to be optimized; because it is not always the case that optimization in one process is the best thing for the overall system.

The next blog will cover Role 2. Reporting on QMS performance.

Contact me for a free phone consultation and for my free ISO 9001:2015 Readiness Checklist and perform a quick self-assessment to gage your preparedness for the new standard. Then call to see how I can help.

920-841-3478

Steve@TheRightApproachConsulting.com

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EU Conflict Minerals Negotiators Reach Agreement

On June 16, the European Union (EU) Commission, Council and Parliament agreed on a framework for conflict minerals legislation. Overall, the legislation will be less burdensome for IPC members and the electronics industry than previously proposed. While the EU Commission had originally proposed a voluntary system, the EU Parliament had voted for mandatory requirements for the entire supply chain. Under the agreement reached this week, due diligence requirements will apply only to the upstream portions of the whole supply chain.

The framework for legislation, which is a working document, will need technical work before it is finalized, including cooperation with the legal services of the European Commission. A vote in the European Parliament could take place before the end of the year, and would have to be followed by a formal adoption in the Council for the text to become law.Conflict-Minerals

Over past four years, IPC has met with EU Commission staff, European Parliament Rapporteur Iuliu Winkler’s staff and several other MEP offices. In the meetings, IPC emphasized the burdens and unintended problems Dodd-Frank has caused, both for manufacturers and the miners in Africa it was intended to help. IPC encouraged the EU to adopt voluntary measures in alignment with the existing Organization for Economic Cooperation and Development (OECD) and other industry programs in order to minimize the burden of compliance.

IPC will continue to actively advocate for our members and industry on this important issue and will continue to keep you informed of any new developments regarding conflict minerals.

Source: IPC Blog June 2016

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Three Things You Should Know About ISO 2015

  1. Timing: ISO 9001: 2015 was released last year, and while the final deadline is 2018; no new certificates will be issued after June 2017. So, depending on your certification date, you may most likely need to comply with 2015 if you have a surveillance or recertification audit after June 2017.
  2. Requirements: There are significant changes to the standard that will require new processes, new training and new execution. You will need time to build history to the new system so don’t delay starting!
  3. Don’t Wait: There are over 2 million companies globally that are ISO registered, and all 2 million of them have the same deadline for ISO 2015, so you will be competing with them for your registrar’s time. Don’t wait until the last minute or your registrar may not be available when you need them and you risk a certification lapse.ISO 2015
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We’re Back! US Manufacturing is Headed for No. 1

It is no surprise that advanced technology is helping to push the US back toward being the most competitive manufacturing country in the world, according to a new Deloitte survey of global CEOs and other senior executives.

U.S. manufacturers and equipment makers are heavily investing in technologies such as the Internet of Things (IoT), smart factories, and predictive analytics that will be critical to becoming globally competitive in the next 4 years. Once atop the mountain, the US will be looking over our shoulder as Germany, Japan and the United Kingdom are making similar investments that will maintain or improve their competitive positions. It is interesting to note the survey ranks talent as another critical driver of competitiveness along with a high performing supply base.

07 Oct 1994, Yorkton, Saskatchewan, Canada --- A protective helmet shields a welder from flying sparks. Stik's Welding, Yorkton, Saskatchewan, Canada. --- Image by © Paul A. Souders/CORBIS

While China is still the world’s preferred low cost country (LCC), according to the 2016 Global Manufacturing Competitiveness Index developed by Deloitte and the Council on Competitiveness, the U.S. has moved up from 4th to 2nd, and is expected to secure the top spot by 2020.

Fall from Grace

What has led to China’s anticipated drop to second in manufacturing competitiveness is not a secret; history is a great predictor of future behavior. We saw it first with Japan, then Taiwan, Korea and now China; as these countries economies become more “Westernized”, the cost gap closes up and the issue of freight and inventory risk become a dominant factor.

A recent report by U.K. consulting firm Oxford Economics said that rising wages in China and increasing productivity among U.S. workers led to only a 4 percent gap in costs between the world’s two largest economies; despite the nations’ currency values largely going in opposite directions recently.

Reshoring?

Does this mean work is coming back from China? Yes and no. While many OEMs have learned a hard lesson in terms of intellectual property breaches with outsourcing to Asia and continue to bring this business back, many others will just move to the “flavor-of-the-month” LCC. Current candidates such as Vietnam, Eastern Europe, Malaysia, Thailand, Indonesia, and India are vying for this spot.

Stay tuned; the next 4 years will be very, very interesting!

 

 

 

 

 

 

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Boeing cuts predicted 5 years ago

I was in Seattle last week and all everyone was talking about was the 8,000 jobs Boeing just announced would be cut this year. In July of 2011 I published an article titled “The Beginning of the End for American Manufacturing? about the National Labor Relations Board (NLRB) trying to block Boeing from building a new plant in South Carolina.http://www.therightapproachconsulting.com/wp-content/uploads/2015/07/201107Beginning-of-the-End-American-Manufacturing-July2011_1.pdf

The key to this article was that this move would allow the company to improve their global competitiveness as South Carolina is a non-union, lower cost labor state. By-the-way, FILE - OCTOBER 23: Boeing announced on October 23, 2013 that it's third-quarter income was up 12 percent on commercial airplane sales growth. EVERETT, WASHINGTON - JUNE 13: Boeing 787 Dreamliners sit on the assembly line is pictured June 13, 2012 at the Boeing Factory in Everett, Washington. (Photo by Stephen Brashear/Getty Images)the new plant would also create 3,800 new jobs in South Carolina, and while the lawsuit was not successful, the union is still trying to organize there.

Fast forward 5 years to last week, when Boeing announced that they will be cutting 8,000 jobs (10% of its commercial airline unit) citing the $1 billion in cost savings “…part of a broad cost-cutting drive to keep them competitive.”

Is this a coincidence? I think not.

Increased governmental, regulatory and compliance oversight in business is making it difficult to remain globally competitive, and if this can happen to an industry giant like Boeing, thing of the impact to small and medium-sized businesses like ours…

 

 

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ISO 2015 in Plain English: Support Part 3

Requirement: Clause 7 is called Support, which is basically all of the resources required to support the organization’s primary business. This weeks final review is on Organizational knowledge, Competence, Awareness and Communication.

7.1.6 Organizational knowledge requires the organization to determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. It also requires that knowledge be maintained and made available to the extent necessary. When addressing changing needs and trends, the organization must consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Training_competence

7.2 Competence requires the organization to determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system, to ensure that these persons are competent on the basis of appropriate education, training, or experience, to take actions (where applicable) to acquire the necessary competence, to evaluate the effectiveness of the actions taken; and to retain appropriate documented information as evidence of competence.

7.3 Awareness requires the organization to ensure that persons doing work under the organization’s control are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the quality management system, including the benefits of improved performance, and the implications of not conforming with the quality management system requirements.

7.4 Communication requires the organization to determine the internal and external communications relevant to the quality management system, including on what it will communicate, when to communicate, with whom to communicate, how to communicate, and who communicates.

 

 

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