quality

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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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).

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 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.

3 SEATS LEFT for ISO/TS 16949:2009 Internal Lead Auditor (32hrs)

Folly Beach - Charleston BeachesLast call for our Fall 2014 Automotive Quality Series with our ISO/TS 16949:2009 Lead Internal Auditor Course. We have THREE seats remaining. The courses will be held at the aLoft Charleston Airport & Convention Center. Learn by day. Hit the beach after class. Why not make the most of your professional development? Don't just take a class - experience business differently. Price includes all course materials, parking, wifi, light breakfast, lunch & afternoon snacks. Dozens of food and entertainment options are within blocks from the hotel.

Register & pay online here or by calling 843.469.8279.

Description:   This advanced internal auditing course caters to the full spectrum of auditor responsibilities – from process auditing to audit program management. This course will teach you the fundamental tools necessary to conduct audits using the automotive process approach while providing vital strategic information to top management. Case studies and scenarios make this course fun. If you are looking for a Lead Auditor course for internal processes or supplier quality development, look no further. This course is for you. NEW: We will also discuss the TS Rules 4th Edition and draft of the proposed ISO 9001:2015 standard. Get a jump on what to expect with the changes and it’s potential effect on your management system implementation.

Designed for:  Audit Program Managers, Lead Auditors, Advanced Audit Team Members, Supplier Quality Engineers & Managers, Process Improvement Managers, Quality Directors, Continuous Improvement Managers, Organizational Development Directors, Management Representatives

This course meets or exceeds the training requirements for:

  • Ford Customer-specific Internal Quality Auditor requirements
  • General Motors Customer-specific Internal Quality Auditor requirements

Length:  4 days/32 hours   CEUs:  3.2    A certificate will be given upon successful completion of all course requirements.

The instructor for this course will be Jim Thompson, President of Concentric and Exemplar Global (formerly RABQSA) Accredited QMS Lead Auditor. Register online here, contact us by email at info@cmsicharleston.com or by calling 843.469.8279.

Day 1
▪    Introduction & Welcome
▪    Gathering of Student Goals & Expectations (CSRs)
▪    Overview of ISO 9001 & ISO/TS 16949 – Part I
▪    Selling QMS to Top Management
▪    The Automotive Process Approach
▪    Overview of ISO 9001 & ISO/TS 16949 – Part II
 
Day 2
▪    Use of Turtle Diagrams for Process Mapping
▪    ISO/TS 16949 Requirements – Clause 4.0, Quality Management System
▪    ISO/TS 16949 Requirements – Clause 5.0, Management Responsibility
▪    ISO/TS 16949 Requirements – Clause 6.0, Resource Management
▪    Overview of AIAG Core Tools (APQP & CP, FMEA, MSA, PPAP & SPC)
▪    ISO/TS 16949 Requirements – Clause 7.0, Product Realization
 
Day 3
▪    ISO/TS 16949 Requirements – Clause 7.0, Product Realization
▪    ISO/TS 16949 Requirements – Clause 8.0, Measurement, Analysis & Improvement
▪    Audit Objectives & Auditor Attributes
▪    Process Auditing Breakout
▪    Writing Audit Findings – NCRs & OFIs
 
Day 4
▪    Reporting Audit Findings
▪    CAPA – Corrective Action & Preventive Action
▪    Closing Out Audit Findings
▪    Closing the Audit Cycle
▪    Evaluating Audit Effectiveness
▪    Final Review/Q&A
▪   Student Goals & Expectations (Reviewed)
▪   Course Examination
 
 

7-Day Quality Challenge: Win a Ticket to ASQ Charleston's Lowcountry Quality Conference

ASQ Charleston is hosting the Lowcountry Quality Conference on April 24th & 25th and we are proud to be participating this year (You can get more information on the conference here). With all the excitement around the conference for all the great speakers and fun tours, we want to give away a FREE ticket to the conference to one lucky person. Lowcountry Quality Conference

So, here's what we're doing. It's a 7-Day Quality Challenge! And the details are:

Prize One Ticket the Lowcountry Quality Conference April 24-25, 2014 (A $179 Value)

Logistics One question a day. One entry per correct answer. You can answer over any platform – Blog Comment, Email reply, Twitter with #LCQ2014, Facebook Comment or LinkedIn Comment. Play along from Friday, April 4th to Thursday, April 10th. We'll announce the winner on Friday, April 11th. Happy Weekend!

Timeline Now: Get Excited! Friday, April 4th: We will announce, email, post, give you the first Quality trivia question. Then a new question each day after that until Thursday, April 10th. Friday, April 11th: We will announce the winner April 24th-25th: Enjoy the Lowcountry Quality Conference

The theme this year for ASQ Charleston's Lowcountry Quality Conference is Quality in Practice. This year the conference will include great speakers, workshops, exhibitors and 3 VIP Tours. The tours will be of the Clemson Wind Power Turbine Testing Cell, Charleston Water Systems Treatment Facility and Carnival Fantasy Cruise Ship.

You can check out all the details at the conference website.

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

White Paper: Strategic Planning

Download our latest White Paper Keys to Competitiveness using Strategy. In this paper you will learn the tools to begin to developing an organization strategy plan and use it as a foundation for setting your organization up for success. Here is an excerpt:

How important do you feel planning is to remain competitive? Do companies routinely take time to plan? Typically…no. (Ain’t nobody got time for that!) It is far more exciting to be reactive – to be the hero that solves the problem at the time of crisis. Whatever adrenaline rush you get from this, it is a poor way to run a business. Many of your competitors ARE planning. This puts you at a distinct disadvantage. However there are some companies are not planning. So applying this discipline gives you the competitive advantage over others.

It all starts with strong leadership.

Great leaders inspire others to greatness. They get more energy and creativity from their staff than complacent managers. They help create vision, urgency, discipline, and accountability – many keys to successful strategic planning. Leadership is needed for strategic plan development, strategic plan implementation, and strategic plan systematization.

You need to ask yourself this one question… Are you a strong leader that is ready for the strategic planning processes? 

To read the entire White Paper: Keys to Competitiveness Using Strategy you can download it here.

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

Top 3 Tips for Quality Professionals

Top Tips for Career Advancement for Quality Professionals2014 marks my 20th year as a Quality Assurance professional and devout practitioner. I frequently refer to my career path as a "genetic mutation put to good use”. No matter where I go or what I’m observing, be it personal or professional, it is difficult for me to shut off the portion of my brain that always wants to make things better. Let’s dub this phenomenon “Chronic PDCA (Plan-Do-Check-Act) Syndrome”.

Chronic PDCA (Plan-Do-Check-Act) Syndrome

Our strengths as quality professionals can also be the very attributes that prevent us from being all that we can be. Just as our “mutations” give us worth in industries requiring attention to detail and the ability to visualize perfection, it is this same attribute that can cripple the forward progress of a thriving business.

Top 3 Tips for Quality Professionals3 Career Tips for the Quality Professional

Using Pareto’s 80/20 Rule (see The Pareto Principle), I’ve narrowed down my long list of lessons learned into the following 3 tips:

  1. Avoid Delayed Perfection
  2. Don’t Take It Personally
  3. Keep Moving Forward

Tip #1 - Avoid Delayed Perfection - Also referred to as “analysis paralysis”, this first tip requires us to walk right up to the edge of a pitfall while being careful not to fall in. Some of the most incredible talents in music, art, writing and product development are started in some dude’s basement because he didn’t want anyone else to see his work until it was perfect. To be honest, I’ve been that dude. I’ll be that dude again many, many times before I’m done.

If you and I owned competing lawn-mowing businesses, and we both had an entire block to mow before sundown (you on one side of the street while I’m on the other), I’m pretty sure that you’d be finished with your 10th and final house while I’m still manually cutting each blade of grass on house #3. Now, assuming that the customer requirements were the same (i.e. mow the yard for $30/yard), we can assume that my efforts would result in the loss of future business.

Quality is nothing without a gig. You can’t do a quality job if you don’t have a job. You won’t have a job for long by only completing 30% of the lawns while your competition is sitting in the truck sipping a cold PBR whilst laughing at you. In this example, you’re probably still in business and I’m probably not.

Note: As I write this blog, I’ve already changed the “1.” to “#1” to “1)” and back three or four times. DANG IT Tip NUMBER ONE!

Tip #2 - Don’t Take It Personally - Being a quality assurance professional comes with the tough duty of trying to convince people, who often times don’t report to you, to execute a process in a specific manner (i.e. best practices, standard work, response to data, etc.). Not only is it difficult to win over the trust of your colleagues at a similar organizational level, but it becomes increasingly difficult the further up you go.

Math is math and facts are facts. But have you ever had a fight with your spouse or other loved-one, presented all of the facts that show you were “right”, while still coming out the loser? Methodology and timing are just as important as facts. If there is a better way to execute a process, reduce waste or protect the customer, stick to your guns. Sometimes a great idea isn’t so great if the timing is off. Its extremely hard to think in terms of improvement when you’re struggling to get through the day. Recognize what is important to the company, as well as the customer, and stay persistent. Don’t give up on your role of taking organizational performance to the next level simply because Mrs. Director of Materials didn’t come to your meeting. Don’t take it personally.

Tip #3 - Keep Moving Forward - The third and final tip is my favorite. I don’t have any tattoos, but if I get one, this would be on the short list (which is why I don’t have any tattoos). In the spirit of improvement and the perpetual PDCA Cycle, you MUST continue to move forward. Competition and stakeholders will always drive the need for improvement. “Improvement” is not going anywhere. Congratulations… the quality profession has a bright future. However, avoid being hypocritical by demonstrating improvement, both personally and professionally.

All 3 words in this tip are extremely important and work hand-in-hand with tips 1 and 2. Do not post-pone movement due to imperfection. Move towards perfection. Do not take it personally when others fail to embrace change with open arms. Change is hard. Remember that. Do not stop. As a quality practitioner, others are looking for you to make it easier to serve the customer and improve the “ease of doing business". Keep moving forward in your quality role. Keep learning. Keep trying new methods and share what you’ve learned with others within your organization.

Even though I make it sound easy, these are not easy tips to implement. Perfectionism is a double-edged sword because while you want to strive for the best quality and to do better and move forward that same perfectionism can paralyze that movement because you’re never ready for the world to know about that thing because its not perfect. Are you a perfectionist? Which of these tips resonates with you the most and how to you plan to implement them?

Regards,

Jim Blog Signature

p.s. Interested in more advice or personal training for your career development? Contact us to see how we can customize a personal training catered to your specific needs.

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.

Quality Challenge: Day 7 Question

Quality Trivia Challenge Day 7 Question

 

Which SC-based automotive OEM just announced a $1 billion investment in expanding?

If you answer correctly you get one entry into the drawing for a ticket to ASQ Charleston's Lowcountry Quality Conference on April 24th & 25th. There are several ways to enter; leave a blog post comment, reply by email, leave a comment on Facebook, reply on Twitter or reply on LinkedIn. If you have the answer just get it to us. The full details of the challenge are below.

Good luck and we hop to see you at the Lowcountry Quality Conference!

 

Challenge Details

ASQ Charleston is hosting the Lowcountry Quality Conference on April 24th & 25th and we are proud to be participating this year (You can get more information on the conference here). With all the excitement around the conference for all the great speakers and fun tours, we want to give away a FREE ticket to the conference to one lucky person.

Lowcountry Quality Conference

Prize One Ticket the Lowcountry Quality Conference April 24-25, 2014 (A $179 Value)

Logistics One question a day. One entry per correct answer. You can answer over any platform – Blog Comment, Email reply, Twitter with #LCQ2014, Facebook Comment or LinkedIn Comment. Play along from Friday, April 4th to Thursday, April 10th. We'll announce the winner on Friday, April 11th. Happy Weekend!

Timeline Now: Get Excited! Friday, April 4th: We will announce, email, post, give you the first Quality trivia question. Then a new question each day after that until Thursday, April 10th. Friday, April 11th: We will announce the winner April 24th-25th: Enjoy the Lowcountry Quality Conference

The theme this year for ASQ Charleston's Lowcountry Quality Conference is Quality in Practice. This year the conference will include great speakers, workshops, exhibitors and 3 VIP Tours. The tours will be of the Clemson Wind Power Turbine Testing Cell, Charleston Water Systems Treatment Facility and Carnival Fantasy Cruise Ship.

You can check out all the details at the conference website.

Quality Challenge: Day 6 Question

Quality Trivia Challenge Day 6 Question

 

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

If you answer correctly you get one entry into the drawing for a ticket to ASQ Charleston's Lowcountry Quality Conference on April 24th & 25th. There are several ways to enter; leave a blog post comment, reply by email, leave a comment on Facebook, reply on Twitter or reply on LinkedIn. If you have the answer just get it to us. The full details of the challenge are below.

Good luck and we hop to see you at the Lowcountry Quality Conference!

 

Challenge Details

ASQ Charleston is hosting the Lowcountry Quality Conference on April 24th & 25th and we are proud to be participating this year (You can get more information on the conference here). With all the excitement around the conference for all the great speakers and fun tours, we want to give away a FREE ticket to the conference to one lucky person.

Lowcountry Quality Conference

Prize One Ticket the Lowcountry Quality Conference April 24-25, 2014 (A $179 Value)

Logistics One question a day. One entry per correct answer. You can answer over any platform – Blog Comment, Email reply, Twitter with #LCQ2014, Facebook Comment or LinkedIn Comment. Play along from Friday, April 4th to Thursday, April 10th. We'll announce the winner on Friday, April 11th. Happy Weekend!

Timeline Now: Get Excited! Friday, April 4th: We will announce, email, post, give you the first Quality trivia question. Then a new question each day after that until Thursday, April 10th. Friday, April 11th: We will announce the winner April 24th-25th: Enjoy the Lowcountry Quality Conference

The theme this year for ASQ Charleston's Lowcountry Quality Conference is Quality in Practice. This year the conference will include great speakers, workshops, exhibitors and 3 VIP Tours. The tours will be of the Clemson Wind Power Turbine Testing Cell, Charleston Water Systems Treatment Facility and Carnival Fantasy Cruise Ship.

You can check out all the details at the conference website.

Quality Challenge: Day 5 Question

Quality Trivia Challenge Day 5 Question

 

What does FMEA mean?

If you answer correctly you get one entry into the drawing for a ticket to ASQ Charleston's Lowcountry Quality Conference on April 24th & 25th. There are several ways to enter; leave a blog post comment, reply by email, leave a comment on Facebook, reply on Twitter or reply on LinkedIn. If you have the answer just get it to us. The full details of the challenge are below.

Good luck and we hop to see you at the Lowcountry Quality Conference!

 

Challenge Details

ASQ Charleston is hosting the Lowcountry Quality Conference on April 24th & 25th and we are proud to be participating this year (You can get more information on the conference here). With all the excitement around the conference for all the great speakers and fun tours, we want to give away a FREE ticket to the conference to one lucky person.

Lowcountry Quality Conference

Prize One Ticket the Lowcountry Quality Conference April 24-25, 2014 (A $179 Value)

Logistics One question a day. One entry per correct answer. You can answer over any platform – Blog Comment, Email reply, Twitter with #LCQ2014, Facebook Comment or LinkedIn Comment. Play along from Friday, April 4th to Thursday, April 10th. We'll announce the winner on Friday, April 11th. Happy Weekend!

Timeline Now: Get Excited! Friday, April 4th: We will announce, email, post, give you the first Quality trivia question. Then a new question each day after that until Thursday, April 10th. Friday, April 11th: We will announce the winner April 24th-25th: Enjoy the Lowcountry Quality Conference

The theme this year for ASQ Charleston's Lowcountry Quality Conference is Quality in Practice. This year the conference will include great speakers, workshops, exhibitors and 3 VIP Tours. The tours will be of the Clemson Wind Power Turbine Testing Cell, Charleston Water Systems Treatment Facility and Carnival Fantasy Cruise Ship.

You can check out all the details at the conference website.

Quality Challenge: Day 4 Question

Quality Trivia Challenge Day 4 Question

 

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

If you answer correctly you get one entry into the drawing for a ticket to ASQ Charleston's Lowcountry Quality Conference on April 24th & 25th. There are several ways to enter; leave a blog post comment, reply by email, leave a comment on Facebook, reply on Twitter or reply on LinkedIn. If you have the answer just get it to us. The full details of the challenge are below.

Good luck and we hop to see you at the Lowcountry Quality Conference!

 

Challenge Details

ASQ Charleston is hosting the Lowcountry Quality Conference on April 24th & 25th and we are proud to be participating this year (You can get more information on the conference here). With all the excitement around the conference for all the great speakers and fun tours, we want to give away a FREE ticket to the conference to one lucky person.

Lowcountry Quality Conference

Prize One Ticket the Lowcountry Quality Conference April 24-25, 2014 (A $179 Value)

Logistics One question a day. One entry per correct answer. You can answer over any platform – Blog Comment, Email reply, Twitter with #LCQ2014, Facebook Comment or LinkedIn Comment. Play along from Friday, April 4th to Thursday, April 10th. We'll announce the winner on Friday, April 11th. Happy Weekend!

Timeline Now: Get Excited! Friday, April 4th: We will announce, email, post, give you the first Quality trivia question. Then a new question each day after that until Thursday, April 10th. Friday, April 11th: We will announce the winner April 24th-25th: Enjoy the Lowcountry Quality Conference

The theme this year for ASQ Charleston's Lowcountry Quality Conference is Quality in Practice. This year the conference will include great speakers, workshops, exhibitors and 3 VIP Tours. The tours will be of the Clemson Wind Power Turbine Testing Cell, Charleston Water Systems Treatment Facility and Carnival Fantasy Cruise Ship.

You can check out all the details at the conference website.

Quality Challenge: Day 3 Question

Quality Trivia Challenge Day 3 Question

 

Which two international standards does ISO 19011 support?

If you answer correctly you get one entry into the drawing for a ticket to ASQ Charleston's Lowcountry Quality Conference on April 24th & 25th. There are several ways to enter; leave a blog post comment, reply by email, leave a comment on Facebook, reply on Twitter or reply on LinkedIn. If you have the answer just get it to us. The full details of the challenge are below.

Good luck and we hop to see you at the Lowcountry Quality Conference!

 

Challenge Details

ASQ Charleston is hosting the Lowcountry Quality Conference on April 24th & 25th and we are proud to be participating this year (You can get more information on the conference here). With all the excitement around the conference for all the great speakers and fun tours, we want to give away a FREE ticket to the conference to one lucky person.

Lowcountry Quality Conference

Prize One Ticket the Lowcountry Quality Conference April 24-25, 2014 (A $179 Value)

Logistics One question a day. One entry per correct answer. You can answer over any platform – Blog Comment, Email reply, Twitter with #LCQ2014, Facebook Comment or LinkedIn Comment. Play along from Friday, April 4th to Thursday, April 10th. We'll announce the winner on Friday, April 11th. Happy Weekend!

Timeline Now: Get Excited! Friday, April 4th: We will announce, email, post, give you the first Quality trivia question. Then a new question each day after that until Thursday, April 10th. Friday, April 11th: We will announce the winner April 24th-25th: Enjoy the Lowcountry Quality Conference

The theme this year for ASQ Charleston's Lowcountry Quality Conference is Quality in Practice. This year the conference will include great speakers, workshops, exhibitors and 3 VIP Tours. The tours will be of the Clemson Wind Power Turbine Testing Cell, Charleston Water Systems Treatment Facility and Carnival Fantasy Cruise Ship.

You can check out all the details at the conference website.