Operations: not just for hospitals!

Continuing on with the AS9100D “shall series”…

8.0 OPERATION pt 1  

At 80 “shalls”, the Operation requirement has the most by far, which makes perfect sense since Operation covers everything in your organization from quoting through shipping. We won’t go through each and every one, as I would quickly lose your interest, but will highlight some of the most critical shalls in this section.

Plain English Translation

The organization shall plan, implement, and control the processes needed to meet the requirements for the products and services you produce. Is primarily the process you use to convert customer requirements (PO, drawings, CAD data, etc.) into something employees can build the product to (travelers, work orders, etc.)   Operation1

The organization shall plan, implement, and control a process for managing operational risks to the achievement of applicable requirements. This is typically addressed through things like contract review, pFMEAs and/or control plans, and advanced quality planning. Product safety and counterfeit prevention are now shalls, as well as configuration (rev) control. If your operation has design responsibility there are many shalls that control the product design and development process.

The organization shall ensure that externally provided processes, products, and services conform to requirements. This refers to control of your suppliers, including establishing criteria and process for qualification and ongoing performance management.

Control of Production and Service Provision
The organization shall implement production and service provision under controlled conditions. Again, controlled conditions refer to the traveler, work order, etc. and inspection/test of product, including the calibration system.

Contact me to see how I can help you develop your QMS Operation process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

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The Good, the Bad and the Ugly… Joe Green

Continuing with my GBU human interest stories that highlight folks that have made both exceptionally fortuitous decisions, as well as those that will never be inducted into the Good Decision Hall of Fame. I hope you enjoy them.

The Ugly: Joe Green took his dad’s advice and said no to Facebook

Mark Zuckerberg’s college roommate, Joe Green, turned down an offer to help Zuckerberg start Facebook.

Joe Green

When the two were at Harvard, they created a Hot-or-Not-style website called Facemash,
which got the pair in trouble with the university. When Zuck asked Green to help him with Facebook, Green’s dad discouraged his son from doing another project with Zuck.

Had Green joined the company in those early days, he believes he would have gotten about a 5% stake in the company, which today would be worth about $7 billion.

Contact me right away to see how I can help you keep your quality system in the Good category, and avoid descending into the Bad and Ugly.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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Support your local QMS

Continuing on with the AS9100D “shall series”…

7.0 SUPPORT

There are 25 “shalls” in the Support requirement, beginning with the top level shall “The organization shall determine and provide the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system.”

SupportPlain English Translation

This support requirement is about providing the people, infrastructure and suitable work environment to operate the business and the QMS. It includes equipment, calibration, employee knowledge and training, document control and communication. These requirements used to be scattered in multiple areas in the old ISO and AS9100 standards, and the new revision has done a great job of putting them under the same umbrella, where they belong.

 

Contact me to see how I can help you develop your QMS Support process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

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Inspection Is Evil

Come see my lecture  at the IPC Reliability Forum this week in Chicago; register here http://events.ipc.org/events/ipc-reliability-forum-manufacturing-high-performance-products/custom-37-bbdf36707fa54d01a644424e621e5eda.aspx

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. PCB-InspectionCustomer returns increase and/or internal yields decrease; “Let’s hire more inspectors to make sure our customers do not receive the results of our inefficient process.” Whether you find bad parts internally or ship them, the customer is paying for your process inefficiencies either by defects, or the cost of your inspection, rework and repair. I am here to tell you that this approach simply does not work, and I will prove it to you shortly…

Contact me for a copy of this white paper at Steve@TheRightApproachConsulting.com

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Relief may be in sight on Conflict Minerals Regulations

IPC Supports EU Council Formal Approval of Voluntary Conflict Minerals Requirements for Manufacturers

Statement from John Mitchell, IPC President and CEO

April 3, 2017 – On April 3, 2017, the European Union (EU) Council voted to adopt a regulation regarding the sourcing of conflict minerals in high risk zones. Approval by the EU Council is the end of the formal legislative process and the regulation, which was approved by the European Parliament in March, will take effect in 2021.                                       Conflictminerals

The regulation requires supply chain due diligence self-certification of tin, tantalum and tungsten, their ores, and gold originating in conflict-affected and high-risk areas, is mandatory for smelters and importers of raw materials and voluntary for downstream manufacturers whose products contain these minerals.

IPC looks forward to contributing to the work of the European Commission on the various guidelines and other supportive documents for companies covered by the regulation. IPC will continue advocating for conflict minerals regulation that avoids actions.

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We don’t need no stinkin’ plan

Continuing on with the AS9100D “shall series”…

6.0 PLANNING

Actions to Address Risks and Opportunities

When planning for the quality management system, the organization shall determine the risks and opportunities that need to be addressed.Planning

The organization shall plan actions to address these risks and opportunities, integrate and implement the actions into its QMS & evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

Quality Objectives

The organization shall establish quality objectives at relevant functions, levels, and processes needed for the quality management system.

The quality objectives shall:

  • be consistent with the quality policy
  • be measurable
  • consider applicable requirements
  • be relevant to customer satisfaction
  • be communicated & updated as needed
  • be updated, as appropriate

The organization shall maintain documented information on the quality objectives, determining:

  • what will be done;
  • what resources will be required;
  • who will be responsible;
  • when it will be completed;
  • how the results will be evaluated.

Planning of Changes

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner.

 

Plain English Translation

This planning requirement is about the QMS (operations planning is later). Risk is a key new component prevalent throughout the standard. Here it is relative to the identifying risks and opportunities in the QMS. Part of that process is developing Quality Objectives; the rules are; anything labeled as a quality objective must be have a metric in place to measure progress against the goal, and actions taken when they are missed. My typical guidance is to keep to 3-5. The unwritten rule is that two of the quality objectives must be measuring OTD & quality. The last part is owners, milestones & other resources need to be defined for each quality objective.

 

Contact me to see how I can help you develop your QMS Planning process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

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Book Recommendation: The Printed Circuit Designer’s Guide to…Flex and Rigid-Flex Fundamentals

Book Recommendation: The Printed Circuit Designer’s Guide to…Flex and Rigid-Flex Fundamentals American Standard Circuits’ new eBook “The Printed Circuit Designer’s Guide to…Flex and Rigid-Flex Fundamentals” is a must have desk reference for any PCB designer, OEM/ODM, contract manufacturer and PCB fabricator.

Cover

American Standard builds some of the most advanced technology in our industry, and they provide a look behind the curtain at this challenging topic. The book is a wealth of information for anyone in the supply chain using flex/rigid-flex technology. For designers, there is guidance on key callouts, design considerations and material sets or optimum manufacturability.

For PCB fabricators, there are plenty of do’s and don’ts gleaned from decades of first-hand experience. For OEMs/ODMs, the author reviews factors that are cost drivers in this technology arena. Of particular interest to contract manufacturers is the information on what needs to be included in the data package they receive from a customer that will be transferred to the PCB fabricator.

There is something here for everyone. The intent of the book is education, and ASC is providing it as a free download. I highly recommend downloading this book right away!

 

http://i007ebooks.com/my-i-connect007/books/printed-circuit-designers-guide-flex-and-rigid-flex-fundamentals/

 

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Leadership is not for sissies

Continuing on with the AS9100D “shall series”…

5.0 Leadership

Top management shall demonstrate leadership and commitment with respect to the quality management system through:LeadershipQuote

Customer Focus         

Top management shall demonstrate leadership and commitment with respect to customer focus

The Quality Policy

Top management shall establish, implement, and maintain a quality policy

The quality policy shall be available, communicated & understood throughout the organization

Organizational Roles, Responsibilities, and Authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization.

Top management shall assign the responsibility and authority for each of the processes in the QMS

Top management shall appoint a management representative, who shall have the

The management representative shall have the organizational freedom and unrestricted access to top management to resolve quality management issues.

Plain English Translation

Leadership is all about Top Management’s commitment to focus the organization on both the QMS and the customer. This is done through the Quality Policy and the expectation that every employee not only knows the policy, but understands their contribution to it. AS9100 has retained the requirement for a single management representative to be responsible for the QMS oversight, while ISO has dropped it in favor of top management collectively fulfilling this responsibility,

Contact me to see how I can help you develop your Leadership process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

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Scope, not just for rifles anymore.

In the new 2016 version of AS9100, the word “shall” is mentioned 197 times, and as we all know, shall means that there is no gray area. All “shalls” are non-negoitable, which means the requirement is not just a suggestion, but a requirement. Continuing on with the “shall series”…

4.0 CONTEXT OF THE ORGANIZATION II

4.3 Determining the Scope of the Quality Management SystemScope

The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

When determining this scope, the organization shall consider:

  1. the external and internal issues referred to in 4.1;
  2. the requirements of relevant interested parties referred to in 4.2;
  3. the products and services of the organization.

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.

Plain English Translation

The bottom line to this new requirement is that you need to define the internal and external influences on your organization before you can define the Scope of your QMS. While most of the world has long ago defined their QMS Scope, you have to back into this requirement by doing the analysis and making any necessary adjustments to the QMS and/or Scope.

Contact me to see how I can help you develop your Context of the Organization process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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What Must Be, Shall Be…

In the new 2016 version of AS9100, the word “shall” is mentioned 197 times, and as we all know, shall means that there is no gray area. All “shalls” are non-negoitable, which means the requirement is not just a suggestion, but a requirement. Over the next series of blogs, I will break these down by the seven major requirements and try to provide some plain English translation.

4.0 CONTEXT OF THE ORGANIZATION I

4.1 Understanding the Organization and Its Context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

The organization shall monitor and review information about these external and internal issues.

4.2 Understanding the Needs and Expectations of Interested Parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

  1. the interested parties that are relevant to the quality management system;
  2. the requirements of these interested parties that are relevant to the quality management system.

The organization shall monitor and review information about these interested parties and their relevant requirements.

mustbeshallbe

Plain English Translation

This requirement is simply about understanding all the internal & external influences on the company, such as the economy, competition, regulations, branding, product, technology, etc. Part of this analysis is understanding the expectations of those that have an interest in how the business performs, or Interested Parties, such as owners, employees, customers, banks, etc. Then the final part of this is to make sure your quality system is adequate to support all of these attributes.

Contact me to see how I can help you develop your Context of the Organization process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

 

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