Consulting

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).

# # #

12 Strongly Recommended Tasks for Your Risk-Based Thinking / Approach That Will Pass All Audits and Improve Your Business

12 Risked Based Thinking Approach to Pass All Your Audits Concentric ISO ConsultantsHow should manufacturers manage risks on endless challenges to product and process requirements? ISO 9001:2015 is bringing to the overall market; product and service providers, the concept of risk-based thinking / approach with the intention to create the culture of prevention and make it a habit.

Within medical devices, pharmaceutical products, automotive components, and aerospace systems manufacturers there are some product and process requirements which technical acceptance levels are challenging to reach and have been becoming continuously more restrictive for multiple reasons. Some specific examples are the Sterility Assurance Level (SAL) in the medical industries and the Cleanliness Level (CL) in automotive and aerospace. Both requirements are related to contamination.

Different in nature, the medical / pharmaceutical industry deals with biological microorganisms while automotive / aerospace deals with microscopic debris. However, both are very similar from the target standpoint. ZERO is the ideal, unattainable goal; therefore very restrictive acceptance levels are required, standardized, and regulated at the edge of the available knowledge and technology. All around it’s a thousandth fraction of a unit in terms of probability of occurrence or actual mass (ANSI/AAMI ST 67 and ISO/TC 198/WG15 to be released).

Risk management techniques are not new and are standardized by ISO 31000 (General) and ISO 14971 (Application to Medical Devices). So what is the importance of the new concept for risk-based thinking / approach? It is to diligently pursue the more restrictive acceptance levels preparing the way for new products that can make people's life even better. And there is no magic formula other than real, hard work.

The risk-based thinking / approach suggests some "easy to state but difficult to execute" tasks for during a risk assessment:

1. Focus on the intended use of the product.

2. Bring knowledgeable professionals to the assessment (risk assessment itself) and the actual product and actual processes.

3. List of all the known risks to all interested parties: patient, service providers, operators, and estimate the degree of effects.

4. Gather all knowledge about the risks and the likelihood of occurrence.

5. Ensure capable methods of measurement of biological contamination or cleanliness level.

6. Select reliable methods of risk evaluation.

7. Prioritize the risks: rank them according to what is acceptable and what is not.

8. Maximize the availability of suitable manners to eliminate, avoid, reduce or mitigate the risks.

9. Define the validation process for risk mitigation.

10. Ensure comprehensive, detailed, and complete assessments of the designed or implemented manufacturing process. Recognition of the biological and physical limitations for further improvement.

11. Ensure the effectiveness of all actions taken.

12. Ensure there is a robust control plan to sustain the intended process and product performance.

The risk-based thinking / approach is not new to the standards, but in the new ISO Standards revision, it is structured so that it is better incorporated. How is your organization approaching risk assessments? Leave a comment and let us know what best practices you are looking to implement.

If you have any questions or need help in implementing a risk-based approach, Concentric has a solution that will get your organization on the right track to passing your next audit with flying colors.

ISO 9001:2015 May Webinar is now posted

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry specific (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).

Lean Healthcare: Standard Work is Not So Standard

Lean Healthcare Standard Work is Not So StandardIn lean healthcare, it’s amazing how often standard work is missing. Observe the workers and note the variability of the processes. One shift does a task a certain way or an individual has developed their own technique; this variability in healthcare at times is seen as a badge of pride and honor. There are areas in healthcare where individuality can shine but in many areas, standard work should be imperative. One example of process variability that should have a healthcare facility concerned would be the sterilization/instrument decontamination area. If this area cannot produce a written standard work, then the instrument cleaning process more than likely is only as good as the last trainer. That should concern the surgeon as well as the whole operating room staff. Things as easy as labeling blood vials could use a standard work. Do you circle the date or write the date? Does the collector put three initials or just two? I bet most would say that’s all common sense, but do a Gemba and observe the variation. If there is a lot of variation in the simple but important tasks of labeling vials, then it can be assumed variation exists at some magnitude for the more difficult tasks of the decontamination process. Maybe its time to evaluate or start creating standard work. So how does the standard work get developed? One way is to research best practices.

  1. Write the standard work: By putting it in writing, it is more likely to become the standard and remain the standard.
  2. Train to standard work: No more as good as the last trainer. It’s the standard!
  3. Post it: You do not want, “out of sight, out of mind.”
  4. Audit: It enforces, “It’s the standard.”

Have the staff and subject matter experts involved from the start, writing the standard work. Communicating the “why” is paramount when developing and sustaining the standard work. Minimizing process variability which leads to process predictability is great for the patient, the provider and the payer.

Once the variability is gone, then true continuous process improvement can start.

Concentric has SMEs in Quality Healthcare so if you are looking for a healthcare quality assessment or training in lean in healthcare please feel free to reach out and see how we can help.

Charleston’s Talent Demand

In mid-2014, The Charleston Metro Chamber, along with several other local community and higher education organizations, commissioned and participated in a study to compare the higher education offerings in our region with the needs of our employers. National consultants from Avalanche Consulting, as well as the Council for Adult and Experiential Learning (CAEL) worked to identify the region’s higher education gaps. The results of the three phase analysis will help determine where potential gaps exist between the output of local educational institutions and the skills needed by employers, as well as, how to fill both the short- and long- term demand for workforce and skills in the Charleston metro region.

View Report: http://issuu.com/charlestonmetrochamber/docs/rpt_1_-_workforce_supply__demand_an?e=0/8408384

One of the strategic focal points for the Charleston ASQ Section in 2015 will be on the regional needs for talent, and how the section and it’s members can help to support this need. In order to fill the gaps and provide the appropriate level of talent for regional businesses, industry leaders and associations alike must come together quickly.

In the fall of 2014, various projects were kicked off by members of the ASQ Charleston Section Leadership, including participation on the CEJC (Charleston Engineering Joint Council), presentation to SME (Society of Manufacturing Engineering) and a presentation to the Citadel’s School of Engineering. That presentation can be viewed here: The importance of engineering, systems & quality for Charleston’s future

For more information on how you can contribute to the talent demand efforts, contact jim.thompson@cmsicharleston.com or joe.brinson@ifa-rotorion.com.

Reposted from ASQ Charleston

Risk-Based Thinking with ISO 9001:2015

Risk Based Thinking with ISO 9001 2015, AS9100, riskIts projected that starting late 2015 many organizations (thru the quality professional) face the prospect of installing a risk management process into their ISO 9001:2015 quality management system. There are several questions to be answered: [bulletlist]

  • What is risk-based thinking?
  • How extensive does it have to be?
  • How much more work will this be?
  • Could I do this quick enough?
  • How do I get started?

[/bulletlist]

How extensive does it have to be?

Risk-based thinking will be new for ISO 9001:2015. In the aerospace industry, risk-based thinking has been required as a part of the AS-series of standards for years. The federal government and NASA also have standards addressing risk management. The AS9100 standard does not specify how to implement a risk management process.

How much more work will this be?

Actually, risk-based thinking could prove to be a very valuable process for your company. Risk entails a probability and impact of a loss or gain. Some useful risk publications include:

[bulletlist]

  • ISO 31000:2009, Risk management – Principles and guidelines, provides principles, framework and a process for managing risk.
  • (Sept, 2012). NIST Special Publication 800-30 revision 1: Guide for conducting risk assessments.
  • Project Management Institute. (2013). A guide to the project management body of knowledge (PMBOK Guide
  • Prichard, C., & Tate, K. (2013). The risk management memory jogger.
  • ISO Guide 73:2009, Risk management - Vocabulary complements ISO 31000 by providing a collection of terms and definitions relating to the management of risk.
  • ISO/IEC 31010:2009, Risk management – Risk assessment techniques focuses on risk assessment.

[/bulletlist]

Can I do this quick enough?

Get started now! There have been some articles on risk-based thinking in Quality Progress (ASQ magazine). See Palmes, P. (Sept 2014). “A new look: 15 things you must know about the upcoming ISO 9001 revision”. Also, there are opportunities to network with experts through ASQ section meetings and through webinars.

How do I get started?

Seek advice from your Registrar about how they are directing their auditors to assess risk. You may want to write a new risk management procedure containing the concepts and body for a risk-based thinking process. It should follow the steps of the standard you want to use, such as NIST SP80-31. (The NIST standard and NASA procedures/ standards are free to the public.)

There will be more blogs on details of risk-based thinking to follow. Of course, Concentric is in place to be the external resource for you to succeed in implementing a good risk-based thinking process. For Glenn's full article register for our upcoming ISO 9001:2015 Forum - January Webinar. You can get update on all the changes including risk-based thinking. Register online here.

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

Turtle Diagrams

A "Turtle Diagram" is a quality tool used to visually display process characteristics such as inputs, outputs (expectations), criteria (metrics) and other high-level information to assist in the effective execution and improvement of key business processes.

FOR IMMEDIATE RELEASE: Concentric a Nominee for Small Business of the Year Award

FOR IMMEDIATE RELEASE: Contact:
Ronii Bartles Concentric (843) 452-5259 ronii.bartles@cmsicharleston.com acommoncenter.com

Concentric a Nominee for Small Business of the Year Award Concentric Recognized by Charleston Metro Chamber of Commerce

Charleston, SC, May 15, 2013 — Concentric today announced that they are a nominee for Small Business of the Year Award. The Small Business of the Year is awarded by Charleston Metro Chamber of Commerce. Persons have to be nominated by a peer and then have to meet a string of criteria from demonstrating a commitment to good business practices to contributing to the community. Nominations and criteria are submitted and then voted on. Jim Thompson, Founder at Concentric, said of the nomination, “That’s great that we have been recognized as a nominee.”

The nominees will be honored at a reception at the Business Expo on Thursday, May 21st at 3:30 P.M. The winner will be announced in August.

For additional information or to schedule an interview with Jim Thompson, please contact Ronii Bartles at (843) 452-5259 or e-mail Ronii at ronii.bartles@cmsicharleston.com.

Concentric is a group of quality experts that believe in fostering lasting relationships with our clients. We are essentially a firm of independent subject matter experts that help organizations perform better through process design, management system architecture, risk & waste reduction, problem solving and international certification. Our group is built up of experts in Six Sigma, Lean Manufacturing, ISO standards, business law, marketing, strategic planning and intellectual talent management.

# # #

ASQ Lowcountry Quality Conference 2013 & Management System Architect

The 12-Piece Blueprint This past week was a very successful week indeed - full of signs of spring and new opportunities. A major catalyst of our excitement to bring Concentric's story to the Charleston community was the ASQ Lowcountry Quality Conference organized by our local ASQ Section 1122 volunteers. This 2-day conference featured an amazing array of speakers and Quality Professionals who gave attendees their foresight into the future commercial needs of the region. In addition to the great line-up of speakers from various industries across the spectrum, nearly half of the participants were treated to an extended tour of the new Boeing South Carolina campus. It is rare to hear a planning committee genuinely pumped up after the conference ended saying , "Count me in for planning this thing in 2014!" This statement, above all other metrics, was the most impressive indicator of a successful conference with a bright future in 2014.

Concentric was well represented during the conference. It was jokingly stated at various points throughout the conference that "Concentric has provided 7 speakers - 2 actual guest speakers, 1 on standby as a contingency plan and 4 audio speakers. (We donated our A/V equipment.) Robert Jenkins spoke about the leap that is required for an organization to jump from ISO 9001 certification to AS9100C - the latest aerospace quality management system international standards - while I spoke about a new concept I refer to as "The Management System Architect".

The Management System Architect uses stories and real life examples to introduce change agents to simple tools for the purpose of visualizing activities that take place within an organization. Like a traditional architect, the Management System Architect must put together components that ultimately satisfy the needs and expectations of the customer. Unlike a traditional architect, the Management System Architect is challenged with managing elements of an organization that can not be seen by the naked eye. Rather than physical components such as lumber, hardware and fasteners, the Management System Architect must use simple documents such as flowcharts, maps and other visual representations of action to illustrate how activities within an organization fit together.

The Management System Architect

Throughout the next several months, I encourage you to stay tuned to the progress of my first attempt at authoring a real book. The end product will be a book and a workbook. The book will be an in-depth roadmap for management system implementers and process owners on how to use twelve tools over the course of twelve months. These tools will guide "architects" as they build the fundamental framework of organizational flow and interactions. The accompanying workbook will be a supplement of dozens of downloadable tools and templates allowing you to customize the tools to fit the functions and branding of your specific operations.

We are all extremely busy. Writing a book has been on my bucket list since my mid 20's. Although I failed to make that goal by 30, there is still time to write a book by the time I'm 40. (Dr. Leah Jackman-Wheitner reminded me that just because I missed the 30-year mark, that doesn't give me an easy way out. "There's still plenty of time to write your dang book!") Like any good engineer, having deadlines, metrics and a good plan is what will drive my behavior. By adding accountability to the formula, there is nowhere to hide. I'm asking for your participation. I'd like you to help me by being my accountability partner.

Here are the major milestones: May 17th, 2013 - Management System Architect Toolbox featuring 55+ tools & templates (eWorkbook) May 31st, 2013 - Management System Architect Toolbox (Hardcopy Workbook) June 28th, 2013 - Free Chapter available for download to our blog subscribers November 30th, 2013 - Completion of First Edition of The Management System Architect (eBook) December 21st, 2013 - The Management System Architect Bundle (Hardcopy Book & Workbook with download code for eBook & eWorkbook)

As our gift to you as a subscriber, here is a link my ASQ Conference slideshow: Http://www.acommoncenter.com/architect

Do you know someone else that may be interested in following my progress? Simply forward this blog post and ask them to subscribe here: http://eepurl.com/f0Swn

Happy 9th Birthday CMSi

February 1st, 2012 marks our 9th year

It was this day precisely NINE (9) years ago today that Concentric Management Systems, Inc. (CMSi) was born. I would like to take this opportunity to reflect on the many failures and many more successes we have had over the years. Thanks to our tenacity, belief in our core values, and most importantly, our valued customers, we are able to be proud of "being in our 10th year of business".

CMSi is effectively “re‐launching” bigger and better than ever in 2012 following the successful completion of a major project (42 months) with a key client that required nearly all of my time. This re-­emergency allows us many opportunities to grow where we can grow best - near the beach! We couldn't be more pleased to call Charleston our new home.

Very special thanks is in order to my wonderful staff, our team of amazing consultants and the customers that allow us to grow bigger and better every day! I truly appreciate the trust, hard work and partnerships we have formed in this anything-but-traditional organization.

Here's to another 9 years!

Cheers,

Jim Thompson - President
Concentric Management Systems, Inc.

Mission Statement - February 1st, 2012

We support the world’s leading organizations in their pursuit of excellence through the provision of training, consulting and auditing services. We are dedicated to providing services that exceed the expectations of our customers by being deliberate about delivering the highest level of customized service possible. We believe in steady growth with integrity.

We also strive to be the first choice for representing independent subject matter experts by developing and managing mutually beneficial, long-­‐term business relationships. By facilitating customer relationships, we bring tremendous value to our network of consultants -­‐ allowing more time to focus on exercising core competencies and less time on administrative burden.

The NEW Concentric

Welcome to the new face of CMSi!  We are very excited to call Charleston, SC our new home in 2010.

Concentric Management Systems, Inc. is a group of technical experts specializing in process improvement & management system certification specializing in ISO 9001, ISO/TS 16949, ISO 14001 and AS9100 certification. 

We hope you enjoy the new and dynamic website, blogs, posts and information sharing tools that will be provided at no charge.

May the new CMSi find you well in the 2010 and beyond!