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…

 

 

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.

 

 

Requirement: Clause 7 is called Support, which is basically all of the resources required to support the organization’s primary business. This weeks review is on Monitoring and Measurement.

7.1.5 Monitoring and measuring resources (Calibration in Plain English)

7.1.5.1 General requires the organization to determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. This includes ensuring that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken, and are maintained to ensure their continuing fitness for their purpose. CalibrationFinally, it requires the organization to retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.


7.1.5.2 Measurement traceability
refers to standards traceable to international or national measurement standards; and also requires that measuring equipment be identified in order to determine their status, and safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. Finally, it requires the organization to determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and to take appropriate action as necessary.

This last sentence is driving an industry practice of identifying the measurement equipment ID on inspection/measurement records to trace product to measurement devices.

Contact me 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

Clause 7 is called Support, which is basically all of the resources required to support the organization’s primary business. Resources are broken down into a number of areas: General, People, Infrastructure, Environment, Monitoring/Measurement, Organizational Knowledge and Communication.

General refers to the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. In simple terms, this is management’s commitment to provide people, time and systems to support the QMS.Support

People requires the organization to determine and provide the people necessary for effective implementation of QMS the operation and control of its processes.

Infrastructure requires the organization to determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Maintenance is a primary aspect of infrastructure, including buildings, utilities, equipment, transportation, and information and communication technology.

Environment means the work environment and includes a combination of human and physical factors, such as social, psychological and physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

Contact me 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

 

Dan Beaulieu interviews Steve Williams of The Right Approach Consulting (Watch the interview here  http://realtimewith.com/rtwboot/show.php?id=91&vid=3970 ) on REALTIME with IPC to talk about what companies need to change to comply with the just released 2015 version and why companies need to start NOW!

IPCinterviewContact me 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

 

Inspection Is Evil

A wise man once said “Inspection is Evil”; …actually it was me and I didn’t say it just once, I say it every chance I get. Inspection is a non value-add activity and companies tend to use it to hide many sins. Traditionally, leaders of American industry have had a one-size fits all solution to just about any manufacturing problem they encounter; throw more inspectors at it. Customer returns increase … Read the entire white paper here:  http://iconnect007.uberflip.com/i/649323-pcb-mar2016/11

Inspection

Contact me 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

 

Don’t miss THE PCB industry social networking event of the year! Steve Williams interviews Tara Dunn and Judy Warner on their brainchild, what it’s about, and how you can attend or sponsor one of this year’s three regional events. Watch the interview here…

http://realtimewith.com/rtwboot/show.php?id=91&vid=3988

GeekaPalooza

Planning has always been required and buried in other areas, but is now a stand-alone requirement. The basic function of Planning is simply to meet customer requirements through the processes you have put in place to manufacture your product. This is where the standard really makes a major change by focusing on Risk Based Thinking.

In addition to this clause, the terms ‘risk’ and ‘opportunity’ are made throughout the standard. The path to Risk Based Thinking has three paths:

  1. Actions taken to identify, analyze and address any potential risk:
    • Quoting
    • Up front engineering
    • pFMEAs
  2. Quality objectives and planning to achieve them:
    • Requirements for objective planning had been very loose but are now greatly tightened up
    • An objective should include a description of who is responsible, what is the target, when is it planned to be achieved
    • Progress must be monitored
    • Objectives must be set for relevant processesPlanning
  3. Planning of changes:
    • A very robust Change Management process is required
    • Revisions, Processes, Technology

 Contact me 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

 

 

How can you meet the requirements?

As discussed last week, the good news is that the new requirements are very similar to the current version, so major changes are not required in the way top management must be involved in the QMS. The below list are ways to demonstrate that top management has a commitment to the QMS, typically through the Management Review process:
Top Management is responsible for:

  • The measurement of the QMS effectiveness
  • The Quality Policy and Quality Objectives
    • Communicating throughout the organization
    • Measuring actual to plan
  • Assuring the QMS is part of the business processes, not just the “quality department”
  • Providing needed resources
  • Continual improvement
  • Ensuring customer, statutory, and regulatory requirements are understood and met, and employees understand why this is importantQMS
  • An organizational focus on customer satisfaction
  • Establishing organizational roles, responsibilities, and authorities
    • Accountability

Contact me 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

 

Requirement

A major change in ISO 2015 is more focus on the company supporting the quality system. “Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction” (7.2.1 and 8.2.1).

Management Commitment has always been a major part of ISO, but the 2015 version places more emphasis on this requirement. Total “Top Management” involvement is not optional! Section 5 of the new standard is all about leadership, and most of these requirements are very close to those in the current version of the standard under the management responsibility requirements.leadership

The first subsection is about the ways that top management needs to demonstrate leadership and commitment with respect to the QMS, such as being accountable for the effectiveness of the QMS, ensuring resources are available, promoting continual improvement, and ensuring the Quality Policy and objectives are in place and consistent with the goals of the organization and the QMS. The other three subsections cover the need for customer focus, requirements for the Quality Policy, and the organization’s roles, responsibilities, and authorities.

Next week we will discuss the things you need to do to comply with the Leadership & Management Commitment requirement.

Contact me 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