The Power of Empowerment

As I find myself in my mid-40s, I have noticed a bit of a changing of the tides lately. I’m starting to recognize a shift from spending much of my time ASKING questions to more of my time in ANSWERING questions. One question that I’ve spent a lot of time with lately could be categorized as “What do you wish you knew then that you know now?” with regard to my professional career. While there is more than one answer for me, the answer that seems to illicit a lot of emotion and often times even anger with others is the topic of empowering others - specifically with empowerment around information.

I have found myself around the board room table with thousands of company leaders as a consultant, auditor and instructor. Very rarely does the leadership team say “You know… we’re not doing a very good job at leading our people. We’re not managing as well as we could be by developing our people, tools and other resources.” The day shift thinks the night shift is the problem. The Baby Boomers blame the Millennials. Top management points the finger down the ladder. “They’re so damn lazy…” or something about everyone else being a bunch of idiots. Whatever it is, it ain’t my fault.

Show me an organization where leadership uses this kind of language about their people and I’ll bet we’ll also find a severe lack of empowering others with regard to action and decision making. Metrics are not shared, communication is poor and being a manager (hierarchy) is more important than leadership .

From my perspective, the single most significant factor that differentiates these two types of cultures is empowerment. Randy Boyd, CEO of PetSafe discussed the power of empowerment and how empowerment played a pivotal role in the transformation of his company.

Companies that share relevant key indicators, and teach their associates how to understand the data that is being presented, clearly out-perform those organizations where top management keeps information close to their chests.

Here are a few empowerment benchmarks and best practices observed during my audits and consulting work days:

  1. Stall Art installed in restrooms by the CEO showing cost of quality metrics for the previous month alongside a photo of a Lamborghini and a Ferrari stating “$xxx,xxx = WE PISSED AWAY THESE TWO COMPANY CARS LAST MONTH”.

  2. Real time indicators streamed throughout the facility showing leading indicators such as # of parts produced/hour, # of near miss incidents reported (safety and quality), $ of rework/scrap/repair as a % of overall production, etc. Indicators were not only presented in common areas on TV monitors, but they were also presented on all computer screens as screen savers so even the folks offsite could stay abreast of the latest performance indicators.

  3. Daily stand up meetings performed around a central communication board used to provide visual communication of process-oriented metrics. Each day area leaders would pick an associate at random to tell the story of the posted information. A bit of a pop quiz approach, used to ensure that everyone is aware of past performance, present status and future expectations.

  4. Problem solving groups (PSGs) that are taught how to run their own problem solving sessions, at the place where the work is performed, using simple tools such as the A3, 8D, Corrective Action Forms, etc. Teams are cross-functional and must continue to improve their work by solving issues that effect the customer, create waste or decrease risks by clearing showing a connection between project results and improved indicators.

If you are a leader, I strongly encourage you to empower those that have an effect on the organizational health and improvement strategy. Empower your people then hold them accountable for their results. Be consistent and create an environment that encourages others to act like owners, take risks and learn from their mistakes. You see a difference, I assure you. And let’s not forgot to have a little fun along the way (see Brother’s Osborne video above).

Headshot - Jim Thompson.jpg

James Thompson has over 25 years of experience serving domestic and international organizations in their pursuit of organizational excellence. James also specializes in leadership development and advanced manufacturing techniques.

In 2003, Mr. Thompson founded Concentric in order to advise customers in organizational improvement, process optimization and integrated (concentric) management techniques. James has led hundreds of projects in Lean, ISO 9001, IATF 16949 + AIAG Core Tools, AS9100, ISO 14001, ISO 45001 and other organizational excellence (OE) implementation projects. In 2008, he relocated the business to Charleston, SC due to demand in cost reduction efforts, particularly in the automotive & aerospace manufacturing sectors. James is an Exemplar Global accredited QMS Lead Auditor, Certified Master Management Consultant (CMMC) and Lean Six Sigma instructor. You can find more information about him on our website here.

12 Tools for the Ultimate Management System

During my first 25+ years of working with various organizations and leadership team members, I've noticed that most struggle with the concept of a management systems or processes that make up a system. A mentor of mine once stated "No one wants to build a house. But everyone sure as hell shows up when its time to paint it." I thought that was not only really funny but also similar to building and maintaining management systems.

But what the heck is a management system anyway? Think of an individual process as a single gear on a clock. The entire clock is the system. If one or more gears (processes) are defective, the overall performance of the clock is likely compromised. Every gear matters.

Step 1 - Engagement. When I work with teams on management system development (i.e. various 3rd-party certifications) or process improvement (i.e. lean or Six Sigma projects), eyes tend to glaze over. But as soon as I put a colorful spreadsheet up on the screen, the engagement factor goes through the roof! In fact, there seems to be a direct correlation between the former naysayers and their immediate involvement in the discussion once a tangible tool is presented. "Well... what I would do is create a formula at the bottom of each job function so that the average competency score turns red once we fall below a minimum number of qualified workers." says the Engineering Manager. Five minutes earlier that same manager had a clear look of "This is all b.s.!" on his face. I know. I get it. I feel your pain. Yet the voice inside my mind is screaming "Ahhh HA! I got you on the hook buddy and you don't even know it."

"A person hears only what they understand." - Johann Wolfgang VonGoeth

Step 2 - Ownership. Bottom line... change is hard. Creating new habits is hard. Trying to wrap your head around quality practices and principles is about as fun as doing taxes or updating your Will. But playing with tools such as charts, graphs and spreadsheets is fun. Right?! Creating and maintaining simple, visually appealing tools that are a visual representation of your company's health or your process scorecard, is more likely to gain traction than generic principles or requirements documented in international standards. Am I right?

Step 3 - Maintenance. Instead of talking in concepts, try putting these 12 tools in front of your leadership team. Consider each tool simply a placeholder. You probably have most of these tools in one shape or another. Simply replace the tools that are shown in this video with your tools. Your management system architecture MUST BE YOUR OWN in order to create value and real, long-term improvement.

If I can help in any way, please do not hesitate to reach out via LinkedIn IM, my various socials @jimthompson2001 or

Good luck Fellow Architects!


New ISO 18091 Released - QMS for Local Government

Today, ISO launched their video introduction of the newly published ISO 18091:2019 Quality management systems -- Guidelines for the application of ISO 9001 in local government. Although the ISO 18091 document was originally published in 2014, adoption of ISO 9001 in local government has been slim thus far.

ISO 18091 is applicable to all local government processes at strategic, managerial, tactical and operational levels in order to constitute a comprehensive QMS that focuses on the local government achieving its objectives. This document provides support for local government in providing reliable and effective services to the local customers/citizens. Guidance also includes tools for measuring and monitoring of various processes and their respective levels of maturity.

Message from ISO Secretary General, Sergio Mujica, about the launch of ISO 18091:2019, Quality management systems -- Guidelines for the application of ISO 9001 in local government

This new standard can be purchased directly from ISO at

Core Tools Support (CTS) Software Released

March 26th, 2019

AIAG announced the release of their core tools support software, a cloud-based solution for authoring and managing core tool documentation such as FMEAs, Control Plans and PPAP documents. The software also allows for collaboration across multiple sites.


  • Linkages between forms such as Control Plan & FMEA

  • Flexibility in creating task templates

  • Reporting across parts and projects

  • Main menu showing tasks, priorities, meetings, calendar & more

  • Search bar for quick content look-up

  • Instant updates of latest forms & templates

  • Tracking & uploading of PPAP documentation (i.e. GR&R studies, design records)

  • Project planning tools for APQP (i.e. meeting minutes, action tracking, etc.)


Member: $360 annually per concurrent user

Non-Member: $360 annually per concurrent user

Additional Storage: $120 annually per 50GB

Language: English

Job Postings from Client (BAE Systems)

The following positions have been posted and are in need of fulfillment immediately. Compensation packages are great and may include relocation.

Sr. Supplier Quality Engineer:

Supplier Quality Engineer:

Sr Quality Engr - Continuous Improvement Leader:

38 Required Records of ISO 9001:2015 (20) & IATF 16949:2016 (18)

QMS - ISO 9001:2015    

    0    4.4 - Confidence (as needed)
    1 - Accurate measurement resources
    2 - Basis used for calibration
    3    7.2 - Competence of people
    4 - Requirements review
    5    8.3.2 - D&D Requirements met
    6    8.3.3 - D&D Inputs
    7    8.3.4 - D&D Controls
    8    8.3.5 - D&D Outputs
    9    8.3.6 - D&D Changes
    10    8.4.1 - External provider (supplier) monitoring
    11    8.5.2 - Unique ID
    12    8.5.3 - Unsuitable customer or supplier property
    13    8.5.6 - Changes to product or service
    14    8.6 - Authorized release
    15    8.7 - Nonconformity & action authority
    16    9.1.1 - QMS performance evaluation
    17    9.2.2 - Audit program results
    18    9.3.3 - Management Review
    19    10.2.2 - Nature & action of nonconformities
    20    10.2.2 - Corrective action results

Automotive QMS – IATF 16949    

    21 - Risk analysis
    22 - Contingency plans
    23 - MSA
    24 - Calibration/verification records
    25 - Calibration/verification validity of previous measurement results
    26    7.2.3 - Internal auditor competency
    27 - QMS documentation - series of documents list
    28 - Engineering specifications
    29 - Review of requirements for products & services - supplemental
    30 - Development of product with embedded software
    31 - Product approval process
    32 - Automotive product-related software or automotive products with embedded software
    33 - Second-party audits
    34 - Verification of job set-ups
    35 - Identification & traceability - supplemental
    36 - Control of reworked product
    37 - Control of repaired product
    38 - Monitoring & measurement of manufacturing processes

New IATF 16949 Documented Policies and Documented Processes

3 Documented Policies required by IATF 16949:2016
#     Clause     Requirement
1       Corporate Responsibilities policies, including (minimum)
                         a.    Anti-bribery Policy
                         b.    Employee Code of Conduct Policy
                         c.    Ethics Escalation (“whistle-blowing”) Policy
2      5.2.1        Quality policy
3     Record Retention policy

21 Documented Processes required by IATF 16949:2016

#    Clause        Requirement
1       Product safety
2    Calibration/verification records
3    7.2.1    Competence - supplemental
4    7.2.3    Internal auditor competency
5    7.3.2    Employee motivation and empowerment
6    Engineering specifications
7    Design and development of products and services – supplemental
8    Special characteristics
9    Supplier selection process
10    Type and extent of control - supplemental (outsourced processes)
11    Statutory & regulatory requirements
12    Supplier monitoring
13    Control of changes - supplemental
14    Temporary change of process controls
15    Control of reworked product
16    Control of repaired product
17    Nonconforming product disposition
18    Internal audit program
19    10.2.3    Problem solving
20    10.2.4    Error-proofing
21    10.3.1    Continual improvement - supplemental


The Ultimate Problem Solving Roadmap

Roadmap for selecting the right problem solving tool

A rational for problem solving by Sidney Porto & Jim Thompson

When the only thing you have is a hammer… everything looks like a nail. But a hammer isn’t always the tool you need to get the job done right. A problem that we see far too often is the use of the wrong tool, or the SAME tool, for each problem or opportunity to improve a product or process.

With enough experience, solving problems can be intuitive. But only through a commonly understood problem solving methodology is it possible to implement effective solutions for a problem or opportunity at hand. Although we all make small corrections every single day, effective implementation of corrective action through in-depth problem solving take correction to a different level – time, money and discipline included. So how do you know which tool to use for each unique problem or opportunity?

Step 1 – Clearly identify the problem

While PDCA (Plan, Do, Check, Act) is common in the world of management systems and problem solving, Robert Kettering said it best: “A problem well stated is a problem half solved.” Instead of using the PDCA Cycle, we frequently use the acronym IDPDCA. ID = Identify. You can have the best root cause analysis and problem solving techniques in the world, but if you’re solving the wrong problem (i.e. low impact or low return), then your efforts may not be worthwhile. Use the worksheet in Figure 1 - 5W2H Problem Definition Worksheet to capture the who, what, when, where, why, how and how many of the issue observed.

Figure 1 - 5W2H Problem Definition Worksheet

Figure 1 - 5W2H Problem Definition Worksheet

Step 2 – Prioritization based on impact

Figure 2 - Impact Funnel

Figure 2 - Impact Funnel

Problems, risks and opportunities come in various forms of impact and complexity. The impact of an issue can span from a loss of life or limb through something that simply needs to be done to make the lunch room smell better.  Tools ranging from a SWOT Analysis (Strengths, Weaknesses, Opportunities and Threats) to a C&E Matrix (Cause & Effect) or the FMEA (Failure Modes & Effects Analysis) can assist in giving a value to an issue. The bottom line is this – you can’t do everything at the same time. This of this step as a funnel. You can put every issue in the world into the funnel, but you only have the resources to focus on a few at a time. See Figure 2 – Impact Funnel.

We recommend ranking issues from, say, 1 to 10, using 2 to 3 variables such as cost, impact to the customer and ease of implementation. In some cases, such as QMS requirements in the automotive sector (i.e. IATF 16949:2016), prescribed variables such as severity, occurrence frequency and detection risk are all multiplied together for what is called a risk priority number (RPN) to promote focus on the highest risk characteristics.

Step 3 - Selecting the correct primary tool

Figure 3 – List of primary tools based on severity

Figure 3 – List of primary tools based on severity

Figure 3 – List of primary tools based on severity illustrates the relationship between the issue type, issue impact or significance, and the recommended problem solving tool. Simple tools should be used for minor problems that are easy to solve, and where the cause and/or solution may be apparent. Comprehensive tools should be used for complex issues to get to the bottom of what is causing, or may cause, the issue at hand. And comprehensive set of tools should be used for chronic issues such as the methodology found in Six Sigma. Most issues will fall into the category of “solutions unknown” or “complex” and therefore should be solved using the A3, FTA (Fault Tree Analysis), 8D (disciplines) or a variation of two or more of these primary tools.

Step 4 - Selecting the correct secondary tool

In our fourth step, we structure the problem-solving resolution into 3 distinct lanes:

  1. Problem definition
  2. Root cause(s) identification
  3. Corrective action implementation

This sounds simple because it is simple. All fundamental requirements such as containment, validation of alternatives and effectiveness checks will fit into one of these three lanes on the roadmap. See Figure 4 – Roadmap for Problem Solving.

Figure 4 – Roadmap for Problem Solving.

Figure 4 – Roadmap for Problem Solving.

During the root cause analysis phase, ensure that any data being gathered and analyzed is accurate by conducting a measurement system analysis (MSA). Outputs and effective solutions are only as good as the integrity of the inputs and reasonable bias or measurement error (ideally < 10%).

Like Step 3, the effectiveness of your problem-solving results is highly dependable of the set of secondary problem solving tools you have selected. Figure 4 also suggests which secondary tool(s) to use as well as the sequence of usage for optimal results.


Do you feel this roadmap can guide you on most of the formal problem common solving resolution? Want to learn any specific tool described here. Concentric Global counts on a team of subject matter experts in the USA and South America that can help you on this arena.

Download white paper (PDF)

Purchase Problem Solving Tools & Templates

Do your customers hate you?

Here's a quick challenge and reality check to see how you're doing thus far with your organizational improvement goals.  Take an honest look at your customer-facing processes as if you were the customer. Better yet, actually WALK the customer trail. Put yourself in the driver's seat as if you are a customer and analyze the overall experience.  I'm not talking about "...but our company's internal data for defects per million shows that we're making pretty good parts".  I'm talking about taking a long, hard look at customer perception.  How does your customer perceive the overall quality, service and ease of doing business associated with their relationship with you? Have you seen the television show Undercover Boss? Yeah... do that. Customer satisfaction is not always about facts, figures and statistics.  Sometimes it's all about asking this simple question:  "Dear Mr. Customer - How likely is it that you would actually take the time to recommend me to a friend or colleague?" Think about all of the facets of going out do dinner. You judge your satisfaction with the restaurant based on 

Do you measure customer satisfaction by the number of customer complaints you have?

The lack of a formal customer complaint is not a reliable indicator that the customer is satisfied.  Customer complaints are more often a sign that the customer is so extremely dissatisfied that they feel obligated or angry enough to tell you about it.  What about the other portion of customers that simply turn and walk away?  In most business circumstances, by the time a customer has left you, its too late to regain their trust.  You've lost them and they're not coming back.  In fact, there are a certain set of customers that will spend their nights and weekends talking trash about you, your company and their horrible experiences in dealing with your sorry butt.

Ok... now that I've made you feel like a complete loser, let's at least have a little fun here.  Sit back, grab your cup of coffee and feel the pain associated with being a dissatisfied customer.

Want to gauge your customer's perception of you?  Here are some tips and techniques that we've seen work out in the real world:

SIMPLE & LOW COST:  Ask your customer to help you in getting 100% by partnering with you on the solution of 100% satisfaction.  Rather than asking "Is everything ok?", try asking "What would I have to do in order to receive an A+ or 100% rating?"  This approach invites the customer to give you pointers on improvement rather than the traditional invitation for feedback (i.e. "Y'all doing ok?").  By making it an "Us (you and your customer) against them (bad grades)" you create a partnering perspective with your customers in order to solve the puzzle (how to get an A+) together.

MIDDLE OF THE ROAD:  Use a process to measure how likely your customers to "promote" your organization called by using a grading scale called the "Net Promoter Score".  Learn more about this process here.

NPS-Definition copy

COMPLEX & HIGHER COST:  If you are in an organization that can spare a few more bucks, consider using a product like Online Survey Software from Qualtrics.  It is complex software on the back end but simple for your customers to complete on the front end.  Questionnaires and data from survey results are kept on a cloud for simple analysis, quick feedback on-going monitoring of key metrics.

Transition Upgrade Packages

Transitioning to ISO 9001:2015, ISO 14001:2015, IATF 16949:2016 & AS9100:2016 and more...

Clients and their needs vary from one end of the spectrum to the next. We've worked with clients on simply providing a 1-hour overview of a technical specification or standard all the way to creating an entirely new system from the ground up. Regardless of whether the implementation work is done using internal or external resources, we've identified these distinct 10 steps that must be taken to get from start to registration... and beyond. (Please... we hope you go well beyond certification.)

Step 1 - Gap assessment
Step 2 - Implementation planning & action assignments
Step 3 - Deployment of Management System Architecture (12 Tools)
Step 4 - Documentation creation & modification
Step 5 - Organization training & development
Step 6 - Internal auditing & program development
Step 7 - Management review facilitation & improvement
Step 8 - Readiness review
Step 9 - Guidance during 3rd-party auditing
Step 10 - Assistance with closure of post-audit findings

Need assistance transitioning to the latest standards? Let our experts and quick transition tools get the job done on-time, on-spec and on-budget. We focus on integrating ISO standard requirements with your existing business management processes. We specialize in integrated management systems and overall organizational excellence using a SQDCME approach. We teach process owners how to own with confidence.

2-Day Transition Packages starting at $3,195

  1. Step 1 - Gap assessment (2 days)

5-Day Transition Packages starting at $7,995

  1. Step 1 - Gap assessment (2 days)
  2. Step 2 - Implementation planning & action assignments (2 days)
  3. Step 5 - Training & development (1 day)

10-Day Transition Packages starting at $15,995

  1. Step 1 - Gap assessment (2 days)
  2. Step 2 - Implementation planning & action assignments (2 days)
  3. Step 3 - Deploy of MSArch Tools (2 days)
  4. Step 4 - Documentation modification (1 day)
  5. Step 5 - Training & development (2 days)
  6. Step 6 – Internal auditing & program development (1 day)

Chat with us below for question or more info.

Pursuing Excellence Through Workforce Development

In an article published by SC Manufacturing Magazine titled Quality - A Top Business Priority for Manufacturers[1] spoke to me as a quality and process improvement practitioner. One statement that I had earmarked was, “Manufacturers across value chains face competitive and market pressures, customer demand, and complex products and value chains that necessitate a broader approach to how products are designed, delivered, and serviced.” A focus on cost reduction or product quality alone is no longer enough to compete in today’s global market place. Just as cup holders and electric windows are no longer enough to win you over as an automotive consumer, organizations must pursue excellence in more aspects than ever in their quest to produce happy and loyal customers. What is the key to quickly improving organizational performance you ask? Optimization of the performance of each player on the team.

I remember as a kid reading about how a man literally ate an airplane[2]. How did he do it? One tiny bite at a time. This same concept can be applied to the sum of individual performance and its effect on overall organizational performance. The bridge that connects individual performance to optimized process performance, and on to overall organizational performance, is workforce development. Figure 1 illustrates the path from individual development plans (IDP) to organizational excellence (OE).

ISO 9001:2015 Documentation Requirements

Here at Concentric, we like change and typically embrace it. However, we are in agreement that several changes to the 2015 release of the ISO 9001 standard are just annoying. Changes that make understanding of the requirements less simple are, well… not simple. One example is the ambiguity associated with how many and what kinds of documented procedures and records are required. Now that the term "documented information" is being used, subscribers have to get out their ibuprofen, highlighters and dig down into the standard looking for clues like the words maintained (document required) and retained (record required). We've decided to create some more user-friendly tools to help you to better understand what's inside this 42-page document.

The following sections may be helpful in better understanding what is required vs. what is optional, for those of us who appreciate simple. All documented information, be it a traditional document or record, must be controlled in accordance with clause 7.5 Documented information. In order to make implementation and auditing simple, we recommend purchasing a printed copy of the standard and highlighting where the terms “maintained” and “retained” exist. The following sections can also be used as a quick reference guide to assist you in locating documentation requirements, examples of documents that may be used “as needed” and matrices to help you map standard references to your own language.

Is your organization ready to adopt ISO 9001:2015?

If your answer is YES, which best describes the motivation for this adoption:

  • This Standard is your industry’s general practice?
  • It is your customer’s request?
  • It is a Marketing initiative to improve your competitiveness?
  • Or simply because you are ISO 9001:2008 and want to keep the registration?

You may acknowledge one or more of the justifications above as genuine enough in your case. However, your organization’s leadership truly believes that the very first statement of the ISO 9001:2015, clause 0.1 Introduction, is valid, and that’s significantly larger than all the justifications above combined!

“The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives”.

The understanding of this Standard’s requirements, recommendations and permissions demonstrates an intuitive and logical rational that concludes that none of the requirements are unhelpful or useless. Indeed, compliance with ISO 9001:2015, means the minimum applied efforts and resources to achieve a better business structure, with more productivity, more competitiveness and, sure, more growth. Let us explain this rational!

ASQ Charleston Partnership with Concentric Global

ASQ Charleston has entered into a partnership with Concentric Global, a local Quality and Improvement consulting firm, to provide educational opportunities for our local ASQ Members at a discount.

By using promo code “ASQ1122”, ASQ Section 1122 members will receive a 10% discount on full-price 2016 open enrollment classes offered by Concentric.  Visit Concentric’s new website to see upcoming course offerings, and check back often to see when new offerings and other free resources are added.  In return, Concentric will pledge 15% of the course fee back to ASQ Charleston.

Note that Concentric is partnering with Trident Tech for the ISO 9001:2015 Lead Auditor class offered on Feb 23-25 2016.  This promotional price is 50% off regular price (limit 2 students per organization), and as such the promo code offer “ASQ1122” is not valid for this event.

Please consider Concentric for your training needs, and be sure to use Promo Code “ASQ1122” when signing up for 2016 full-price open enrollment courses!

Concentric Web Site

Celebrating 13 Years!

Happy Anniversary Concentric!

To celebrate our 13th birthday we are launched a new website! We are still working through some content to bring you a better experience but you definitely can get the feel for who we are and what we do.

Today we all took a little time out of the day for a celebratory lunch to reflect on our successes.

Look at how good we look? ;)

FOR IMMEDIATE RELEASE: Concentric at the BIOMEDevice

FOR IMMEDIATE RELEASE Contact: Ronii Bartles, Marketing Manager Concentric Management Systems, Inc. (843) 452-5259 |

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

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

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

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).

# # #

ISO 9001:2015 Forum - October Webinar 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 standards (ISO/TS 16949, AS9100, ISO 14001, ISO 45001 and more).

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 Forum - September Webinar 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 standards (ISO/TS 16949, AS9100, ISO 14001, ISO 45001 and more). Visit us online at for more information about our products and services.

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.