QMS

FOR IMMEDIATE RELEASE: Concentric at the BIOMEDevice

FOR IMMEDIATE RELEASE Contact: Ronii Bartles, Marketing Manager Concentric Management Systems, Inc. (843) 452-5259 | acommoncenter.com ronii.bartles@cmsicharleston.com

Concentric at the BIOMEDevice Sidney Porto will represent Concentric at BIOMEDevices Conference in San Jose, CA

Charleston, SC, November 17, 2015 — Concentric Management Systems, Inc. is excited to announce its most recent partnership with TFS Consultants to boost the expansion of business development in the medical devices and in-vitro diagnosis.

With offices in Charleston, SC and in Sao Paulo, Brazil - and counting on flexible experts to serve the whole Americas' territory - Concentric offers management systems products and services, primarily in the manufacturing supply chain. Concentric sells and implements best-in-market software and mobile applications for quality, environmental, occupational health and safety, productivity improvement, and regulatory compliance. Concentric is comprised of dozens of experts in the implementation of international standards (ISO 9001, ISO 14001, ISO 45001, AS9100, ISO/TS 16949, etc.). Implementation services include the performance of internal audits, training and qualification of hundreds of lead auditors, advising clients in lean manufacturing projects, root cause analysis and the standardization of best practices. To learn more about the team at Concentric, visit http://www.acommoncenter.com.

TFS Consultants is a company formed by a group of professionals with diversified knowledge within the Health Sciences global marketplace. Their expertise, gained over 20 years in the market, guarantees a high level of service to assist companies interested in developing and/or expanding their international IVD & Medical Devices business. More information on TFS Consultants can be found at http://www.tfsconsultants.us/home.html.

With a combined expertise of nearly 40 years, the partnership between Concentric and TFS Consultants continues to bring best-in-class practices in the world’s most competitive industries to the medical device and IVD sector.

For additional information, or to schedule an interview with Sidney Porto, contact Ronii Bartles at ronii.bartles@cmsicharleston.com.

Concentric is a Quality & Improvement Resource HUB that leverages the power of Baby Boomers to support improvement projects, making the best companies in the world even better. Through digital products, training, consulting and implementation resources, Concentric helps organizations perform better through leadership development, requirements management, process design, management system implementation, lean, Six Sigma, problem solving and various ISO certifications (i.e. ISO 9001, ISO 14001, ISO 45001, ISO/TS 16949, AS9100 series, ISO 27001, ISO 50001 & others).

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Answers to the 9 Most Commonly Asked Questions about ISO 9001:2015

Answers to 9 commonly asked questions about the ISO 9001_2015 Changes Concentric Quality Management System Experts in CharlestonWe have been abuzz in the Concentric office for months (probably more like a year) on the upcoming ISO 9001:2015 standard changes and have made every effort to get as much information out to you as quickly as we can. So we introduced a monthly webinar series that follows the changes to keep you “in the know”. And we had a few clients that wanted to be on top of the changes so they can swiftly implement new strategies and stay compliant, so we held our first ISO 9001:2015 Lead Internal Auditor Training in August. Between those two platforms we’ve been asked lots of questions on the new standard and have put together a quick guide to answer all those burning questions you might have.  

 

  1. What is the timeframe for adopting the new version? When should an organization get started with the transition? What is going to be the approach adopted by the registrars once the standard is released?

We know, that’s actually three questions, but we have one answer. The Standard approval process is complete and its release will take place in September 2015 (September 23rd to be exact). There will be a three-year transition period for organizations to have its certification converted to revision 5 (version 2015), giving you until the end of 2018. A well-executed conversion may take between 6 and 12 months, but do not plan to get started by Jan 2018 because if you have issues then you will miss the deadline. Call your registrar now to understand their approach. Registrars will grant first-time certifications post Q2 2018 exclusively under the new revision. But a concentration of converted certifications will happen in Q3/Q4 2018. Furthermore, you may want to call your customers now because some of them may require a shorter timeframe to adopt the new standard. And you don’t want to lose a customer because you started late.

  1. Will registrars’ auditors and organizations’ internal auditors need to be re-trained and certified to the new version? Will auditors need to have a different assessment approach?

Yes, auditors will need to adopt a different approach. Registrars’ auditors may not need to be recertified. But we are strongly recommending that internal auditors, including experienced ones, be re-trained in the 2015 version of the Standard. An example of why is because instead of auditors focusing on documented procedures and records, they will need to watch the processes to look for evidence that may not need to be written anymore.

  1. How many new documents and/or procedures are going to be required? Is it not be six mandatory procedures anymore? Does the new version of the standard give the companies more freedom? Is this an advantage or disadvantage?

The 2015 version is not going to explicitly require any new document or procedure. Giving organizations “more freedom”. A few of the documents will not be required anymore, like the Quality manual for instance. Our recommendation is to use common sense to ensure this “freedom” is to your advantage. Instead of eliminating the Quality manual and some procedures that are not mandatory anymore, we are advising our customers to revise them to confirm its compliance with the new concepts in the new standard. This will ensure they remain valuable tools to support the organization’s management system and ultimately the organization’s business. If they are not adequate to serve at least one of the mentioned purposes, then they can be shamelessly eliminated.

  1. How to sell the QMS leadership to the leadership team? Who is going to be in charge of QMS if there will not be MR (management representative) requirement anymore?

The intent in the new version is crystal clear on this topic. The leadership team has to adopt QMS leadership one way or another and demonstrate that business management has incorporated QMS because it cannot be sustained as a satellite set of processes and procedures anymore. Organizations may decide to keep their MR professional, but her/his roles and responsibilities will be different once the QMS leaders will be the business process owners, therefore, part of the plant leadership team.

  1. If a QMS MR is not required anymore, does that means the whole leadership team (process owners) needs to be trained in QMS and ISO 9001:2015?

We strongly recommend training the entire leadership team. Companies may not want to invest in a full lead auditor training for the entire leadership team, but every process owner should attend at last a QMS and ISO 9001:2015 awareness training to fully understand, engage and implement her/his role adequately.

  1. Who are the interested parties and how do we identify them and their requirements or needs?

The new version brings the expanded concept of customers. Interested parties are the actual customers and many others like internal customers, community, government representatives, suppliers, employees and contractors, in summary, anyone that can somehow express an interest in the organization’s business performance. There will not be a written requirement, meaning a template is not provided to gather the list of interested parties and respective requirements or needs. However, we recommend an internal procedure to facilitate this task. For those companies who already gather customer specific requirements, the same repository may be adapted to collect other interested parties requirements or needs.

  1. How do we demonstrate and provide evidence for risk-based thinking? How is risk-based thinking different from risk management? How do we document the opportunities rather than risks?

Risk-based thinking is simpler than risk management. Auditors will not require documented records, but simply verbal justification that it was performed. The standard will not require the usage of a specific tool or methodology to prove evidence of risk-based thinking, neither for identification of risks and opportunities and nor for the subsequent action plan. Companies, intuitively apply risk-based thinking, which will replace preventive action in the new version of the standard. However, businesses do require risk management and mitigation plans, regardless. There are several common risk analysis tools, most of them listed in the Standard ISO 30010, which we strongly advise adopting for the sake of results effectiveness. Firms may want to use simple tools like SWOT (Strengths, Weaknesses, Opportunities and Threats) Analysis and nine box, or expand the usage of their FTA (Fault Tree Analysis) or PFMEA (Process Failure Mode and Effects Analysis) if you are already using these tools due to your industry or a customer requirement. By the way, the BCP (Business Continuity Plan) is another adequate tool for this information and actions.

  1. How should we document the context of the organization? Is the Quality Policy a good place to describe the new context of the organization?

No, the Quality Policy is not a good place for the context of the organization. The context of the organization can be documented, in the Quality manual, if the organization decides to keep it. While some documents and procedures will not be mandatory anymore they can be kept and serve as a good repository for evidence of compliance to new concepts brought by the new standard version.

  1. Continual or Continuous improvement?

Continuous never stops until perfection is achieved. While continual presumes a set target is to be achieved at a certain point or timeframe, and when achieved, a new target is set and the cycle continues with no concept of perfection. Therefore, Continuous is Theoretical (the continuous improvement program of the company) while Continual is Practical (a specific project of the company). The standard refers to continual improvement in several clauses.

This is an exciting time for Quality professionals. We have a lot of work ahead of us. Our next ISO 9001:2015 Forum Webinar is next Wednesday at noon and we will be addressing many of these questions and updating everyone about the publication. You can register here and find loads of resources on our ISO 9001:2015 Resources page. And, if you would like to learn more about the new version of the ISO 9001:2015 you can find the official announcement here along with other helpful information. As always Concentric is here to help with any questions you may have so please feel free to reach out.

ISO 9001:2015 Changes: What It Means for You

ISO 9001, ISO 9001:2015, new standards, international standard changes, change management, planning for change, leadership, tips for preparing for change, QMS changes, quality management, quality systems By now, you’ve surely noticed the buzz around the upcoming changes to ISO 9001. ISO 9001:2015 is projected to be approved and released in Q4 of 2015. If you haven’t heard the buzz, then perhaps you need to subscribe to a blog or two, pick up Quality Digest or raise your head a bit from the rock you’ve been hiding under! All rocks aside, this revision looks to have several significant changes to the standard including the overall structure, basic terminology as well as what is NOT going to make the cut for the new release.

What you can do to start preparing now.

The reality is quite simple. Change happens whether we like it or not. Markets change. Businesses change. Customers change. Nearly everything changes. Most of the time we hate change. Our brains are just programmed that way. We don’t like what we don’t know, but we know what we like. As quality practitioners in particular, our job as change agents tend to be easier when WE are driving the change versus times when we are being asked to change ourselves.

This round of ISO 9001 revisions will undoubtedly be the most significant change to international QMS standard in the past 15+ years. We have seen a draft that gives a little understanding of what to expect with the changes ahead (ref. http://www.acommoncenter.com/iso9001_2015). But what are you doing with the proposed changes, if anything? Are you preparing your organization’s risk management efforts through the use of tools such as the FMEA? What is the appropriate amount of control needed for any process that effects the customer or “other interested parties” (do you know what that means)? Have you appropriated defined expected process outputs by ensuring proper management of customer-specific requirements?

I encourage you to set aside 30 minutes to review this Google+ Hangout video titled ISO 9001 revision - Conversation with Nigel Croft. Mr. Croft is the Chair of the Subcommittee revising the ISO 9001 standard (aka “the horse’s mouth"). Watch the YouTube video here.

Our philosophy is that it is better to be proactive than reactive. While we don’t currently know all of the requirements that will make the final cut, we do have several opportunities to begin to be proaction with the changes ahead. It is at least time to start discussing potential changes to the requirements in order to think strategically about potential impacts and resource needs over the next 3-5 years.

What are some of your thoughts on these big ISO changes that are being proposed in the current draft? How are you preparing for these proposed changes? Let us know in the comments and share with the community. And if you are interested... keep up to date with our upcoming forum and online discussions in September.

Writing a Nonconformance (NCR)

NCR can find broken processes and really help with profit improvement "A problem well stated is a problem half solved." - Charles F. Kettering, American Inventor & Social Philosopher

The first step in solving a problem is to ensure you fully understand what the problem actually is. I regularly see horrible examples of this in practice inside some of the companies I work with. One classic example was in Atlanta, GA a few years ago. Here is the scenario...

Operations Manager: "What the h@!! is going on? Logistics has dropped the ball again! Our #1 line is down because they can't get their heads out of their a$$e$ and keep up with ordering the resin we need. This is our biggest customer!"

The scenario, at least in the mind of the Operations Manager, was that the Jack-Wagons working over in the Logistics Department simply couldn't count. I didn't buy it. In this case, as in most cases where suppositions seem a bit unlikely, I decided to do something I typically do during an audit - walk the audit trail by following the process upstream. This seems like such an obvious move... 1. There's a problem. 2. Walk the trail to find out the source. 3. Ask questions and "show me, show me, show me". HOWEVER, in many organizations, the minute an employee crosses the line into another department he/she is outside of their home turf. A defensive culture will likely breed a departmental approach (staying in your own neighborhood) versus a process approach. If you are not familiar with the process approach, you can learn more about this methodology here from a March 2011 post.

After walking the trail and crossing the territorial boundaries of Production into Scheduling and on to Logistics, I was able to trace back the material in the ERP system with the status "On Hand" and location "Op 120" -  which was the Molding Operations where I had started my hunt. After circling back around to the Operations Manager and hearing another string of Logistics bashing, I started to do some real snooping in the surrounding areas.

Standing at what I'd like to call the base camp of "Mount Unknown Product", I rolled up my sleeves like a eager bidder on Storage Wars and sifted through stacks of components, raw materials and residual miscellaneous. No luck there, although I noted the lack of control and visited that area later in the audit. After asking several questions of several Molding Operators, one of the ladies jumped in with "Oh yeah, that's probably that skid over there in the corner." Sure enough, the skid we were looking for was off in the corner with a simple 2"x2" yellow sticky label on it marked "BAD PRODUCT".

After pointing out to the Operations Manager that the source of the problem was likely one of his team members as opposed to those fools in Logistics, I asked him to consider a better solution. I then pointed out how I would be writing a Nonconformance Report for this finding, and how my nonconformance statement would clearly define the problem at hand. I jokingly stated, "If you want, I can write this NCR in a similar way as that sticky note? I can simply write 'Bad Process' and let you try to remember what I actually meant." He didn't think it was funny.

There were several missing links to the materials and inventory control process I observed during this audit; none that included someone coming to work deliberately trying to screw things up. Links that were obviously broken were the identification of product, controlling suspect or known nonconforming product, use of approved documentation and recording the instance of a nonconformity. An important transactional control was also missing, which was the signal used to notify Logistics that the parts were now unavailable. That signal should have been an ERP move from "Op 120" to "Op 120 Hold". That move to Op 120 Hold would have signaled the Logistics group to order another batch of components in order to keep the customer's order moving forward.

At the end of the day, the use of a simple 1-page Nonconformance Report (NCR) that forces the Originator to follow a simple process checklist (i.e. Yes/No - Did you move product out of IN PROCESS into a PRODUCT HOLD Operations?) may have prevented a late shipment. By the way, the company's poorest performing KPI (key process indicator) was "% On Time Delivery". This KPI was also tied to their variable compensation profit sharing process.

Nonconformance Report (NCR)

Here is an example of a simple NCR Form that may be useful in improving YOUR bonus payout. Click on the image to launch the product and view the PDF or download the native version. Who would have thought a simple form could make your customer and your wallet happier?

Cheers,

Jim Blog Signature

2014 Training Schedule

Lead Auditor Training, ISO 9001:2015 & Management System Academy

Sick of this crazy winter weather? Why not plan a trip to sunny Charleston, SC all while gathering the skills needed to improve customer satisfaction and the process performance? We have just released our 2014 dates for classes, forums & our NEW Management System Academy. As you make your 2014 organizational and professional development plans, we hope that you will consider us as a partner in helping you reach the next level of performance. Be it in a public class, onsite or via an online course, we hope that you will join us in 2014!

Register and pay by Friday, February 14th and save BIG on our March ISO/TS 16949 Lead Internal Auditor Course. Pre-pay by February 14th using promo code "3FOR2" and when you SEND 2 STUDENTS, THE 3rd STUDENT IS FREE!

2014 Public Classes

March 11th-14th  |  Charleston, SC  |  8am-5pm ISO/TS 16949:2009 Lead Internal Auditor Training (32hrs)

Eventbrite - ISO/TS 16949:2009 Lead Internal Auditor Training (32 hrs) 

March 21st  |  Charleston, SC  |  9am-12pm Forum on expected changes to ISO 9001:2015 (Part II)

Eventbrite - ISO 9001:2015 Forum March

September 19th  |  Charleston, SC  |  9am-12pm Forum on expected changes to ISO 9001:2015 (Part III)

Eventbrite - ISO 9001:2015 Forum September

September 23rd-26th  |  Charleston, SC  |  8am-5pm ISO/TS 16949:2009 Lead Internal Auditor Training (32hrs)

Eventbrite - ISO/TS 16949:2009 Lead Internal Auditor Training (32 hrs)

December 9th-12th  |  Location TBD  |  8am-5pm ISO/TS 16949:2009 Lead Internal Auditor Training (32hrs)

Eventbrite - ISO/TS 16949:2009 Lead Internal Auditor Training (32 hrs)

Custom-fit educational solutions based on your specific needs

We believe that customizing your training plan should be simple and completely suitable to your specific needs. We developed the Management System Academy with this in mind. Based on budget (time & expenses), you pick the courses & learning method that works best for you. Itsyour professional development. Make the most of it. Let us help you build the right plan for you and your team. Contact us today to learn more about Management System Academy.

CHOOSE YOUR LEARNING METHOD 1-on-1 Personal Training Onsite Consultation & Mentoring Web-based Classes Video & Tele-Conference Onsite Classes & Workshops Public Classes & Workshops Purchase Course Materials for Self-Study or Train-the-Trainer

And the Winner is...

Congratulations Glenda Montgomery of Charleston, SC!

Glenda Montgomery

 

Glenda Montgomery Quality Assurance/Continuous Improvement/Certified Six Sigma Master Black Belt/Project Management Professional Charleston, SC

 

 

 

Thank you everyone for following and submitting answers! We had a great time getting all the answers and hearing from everyone. Here are all the questions and answers:

1. Why can’t investigators start root cause analysis steps for the missing Malaysian Flight 370? The problem has not yet be defined... or identified. You have to know what the problem is before finding a root cause(s).

2. What does PDSA mean? Plan, Do, Study, Act

3. Which two international standards does ISO 19011 support? ISO 9000 Quality Management and ISO 14000 Environmental Management

4. ISO/TS 16949 is frequently referred to as “TS”. What does TS mean in TS 16949? Technical Standard

5. What does FMEA mean? Failure Mode and Effects Analysis

6. Complete this sentence. “A problem well stated is a problem half _____ .” - Charles F. Kettering Solved

7. Which SC-based automotive OEM just announced a $1 billion investment in expanding? BMW. You can read about here.

The Charleston Section of ASQ (American Society for Quality) will hold its annual quality conference on April 24th & 25th. The Lowcountry Quality Conference is a fun, local, 3-day event aimed at improving the quality of your products and/or services. The conference consists of a blend of technical workshops, 3 options for an in-depth tour of some of the best of Charleston, social networking events, and talks from some of the most profound quality practitioners in the world. This year features a dozen talks and/or workshops, 3 VIP Tours at the new Clemson SCE&G Wind Power Turbine Testing facility, Charleston Water Systems Treatment facility and Carnival Fantasy tour & luncheon. The Keynote will be given by Dr. George Benson, President of the College of Charleston and long-time quality supporter through his membership on the board of directors of The Foundation for the Malcolm Baldrige National Quality Award. This year's theme is Quality in Practice and will give attendees an opportunity to learn how quality practices can improve their organizations bottom line.

For more information about attending any portion of this years Lowcountry Quality Conference, visit http://asqcharleston.org or call 843.469.8279.

ISO 9001 & ISO/TS 16949 Overview

2 Sessions  |  Friday, February 15th

Send 2 Students & 3rd Student is FREE  |  Active ASQ Section 1122 Members can bring a friend or colleague to a February 15th course at NO ADDITIONAL CHARGE.

patriots point (1.23.13)Concentric will hold it's first public training event of 2013 on Friday, February 15th. The morning session will be an ISO 9001:2008 Management Overview followed by an afternoon ISO/TS 16949:2009 Management Overview session. These courses cater to organizations either considering certification or considering the development of a formal quality management system as a tool for improving their business. Both courses will provide an overview of the purpose, timeline, resource needs and other general expectations associated with transitioning to ISO 9001 and/or ISO/TS 16949 compliance.

Course Agenda

  • Introduction & Welcome
  • Gathering of Goals & Expectations (CSRs)
  • Expected Timeline for Compliance
  • Overview of ISO 9001 or ISO/TS 16949 requirements
  • 8 Management Principles
  • Tips on Selling QMS to Top Management

The courses will be held at the new Harbor Breeze on Patriots Point in beautiful Mt. Pleasant, SC (Charleston). Register online here or by calling 843.469.8279.

Promo Codes: 2for3 for multi-student early registration  |  ASQ1122 for ASQ Members

March 27-28 | TS 16949 for Process Owners (16hrs)

ISO/TS 16949:2009 Standard for Process Owners (16hrs)

March 27-28, 2012  |  Charleston, SC

Download the Course Registration Form

Description:   This course caters to the process owners (top & middle management) within automotive manufacturing organizations who have a responsibility to demonstrate their commitment to the quality management system.   This course will teach process owners the value of the automotive process approach, an overview of how to use core tools as intended and the basics of ISO/TS 16949 compliance.  Case studies and scenarios make this course fun.  If you are looking for a course that will help your organization “live it” versus just “look it”, look no further.  This course is for you.

Designed for:  Process Owners (manufacturing, support and management processes), Internal Audit Team Members, Supplier Quality Engineers & Managers, Process Improvement Managers, Continuous Improvement Managers, Organizational Development Managers, Quality Engineers, Manufacturing Managers

Course Agenda

Day 1

  • Introduction & Welcome
  • Gathering of Student Goals & Expectations (CSRs)
  • Overview of ISO 9001 & ISO/TS 16949 – Part I
  • The Automotive Process Approach
  • Use of Turtle Diagrams for Process Mapping
  • Overview of ISO 9001 & ISO/TS 16949 – Part II

Day 2

  • Overview of ISO/TS 16949 Requirements
  • Deep Dive of ISO/TS 16949 Requirements – Clause 5.0, Management Responsibility
  • Lean Manufacturing – Simple Tools & Techniques
  • Problem Solving Techniques
  • CAPA – Corrective Action & Preventive Action
  • Student Goals & Expectations (Reviewed)

Download the Course Registration Form

For a full list of all training dates, visit:  http://cmsicharleston.com/training

Automotive Process Approach

The process approach is taking any activity, or set of activities, that uses resources to transform input to outputs.  For example, every day a restaurant tranforms a certain amount of energy and materials into creating a meal for it's customers.  The output of the process ---> the quality and efficiency of the meal + facility cleanliness + the dining experience + appropriate cost + other expected elements = meeting the desired results of the customers.

The systematic identification and management of the processes employed within an organization, and particularly the interactions between such processes, is referred to as the “process approach”.

Effective operations depend on:

  • identification and management of numerous interrelated processes
  • clear understanding for how processes interact
  • clear expectation of output from one process equals an input into another
  • clear communication of roles and responsibilities
  • an overall understanding of the big pictures (goals & objectives)

The automotive process approach is a requirement from the IATF Rules documents (ref. Rules for Achieving IATF Recognition: 3rd edition for ISO/TS 16949).  Automotive organizations must ensure that priority is given to:

  • questioning processes, the sequence and interactions, and performance against the measures defined
  • focus on processes which directly impact the customer
  • questioning the process objectives/targets, with focus on where targets are not being met
  • focus on issues that have the greatest impact on the customer
  • questioning what plans are in place to ensure targets are met
  • corrective action plans where objectives are not being met
  • following audit trails to linkages between customer concerns, performance against objectives and relevant process documents (e.g. control plan, FMEA, etc.),
  • questioning the clients' process for gathering, communicating and implementing customer-specific requirements

Focus on the customer.  Is the customer satisfied with their dining experience?  How can we do better tomorrow?

Focus on organizational performance.  Did we achieve, as a business, our organizational goals (i.e. make a profit, retain valued staff, satisfy regulatory requirements, etc.)?