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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.

Correlation Matrices

With the official publication of the ISO 9001:2015 International Standard merely weeks away, several veteran auditors and ISO 9001 implementers will be faced with another round of re-learning the new clause structure. Since 1995, I've looked at these various international standards more than any other document in my lifetime. A large portion of the 1987 and 1994 versions are still alive and well in the back of my mind. Memorizing the majority of these standards makes for a tough paradigm shift when a new version comes along - the shifting of the deeply-rooted paradigm. The Bibliography section of the ISO 9001:2015 FDIS (final draft international standard) features a rich source of references, citations and online resources to assist with your transition from 2008 to 2015. One tool that we here at Concentric find particularly useful (i.e. it has been with me daily since the FDIS release) is a document called the Correlation Matrices between ISO 9001:2008 and ISO 9001:2015.

Correlation Matrices

Use this tool to help in the mapping of existing processes, documentation and records (now called "documented information") in order to see how the new standard aligns with your organizational structure. For those organizations that have used the 2000/2008 numbering scheme as the baseline for documentation numbering, note that there is no requirement stating that you have to renumber according to the new structure. In fact, we advise that you build your documentation around the unique processes and internal numbering structure, or other language, that makes sense to you. Until then, the Correlation Matrices can be a useful tool to aid you in your transition.

ISO 9001 Correlation_Matrices from TC176SC02

For other useful resources to assist with your transition, visit our ISO 9001:2015 Resources page featuring recorded webinars, key links, references and other free tools.

ISO 9001 & Six Sigma Infographic

Certification and maintenance of ISO-based management systems (i.e. ISO 9001, 14001, etc.) is often a requirement for doing business with certain customers and sectors. While many organizations struggle to find value with respective their certification efforts, those that use international standards in conjunction with improvement tools such as Six Sigma and APQP wonder how they could have ran a business without a formal management system. Each organization must use the requirements and guidelines of various tools and methods that are most suitable to their own unique vision.

Visual communication through ISO 9001 & Six Sigma Infographic

The fine folks at Midlake Products up in the Buckeye state ("O.H.I.O." ...while moving your arms to form the letters, of course), have shared with us their ISO 9001 & Six Sigma Infographic. This visual tools is used at Midlake to outline how their operations, as well as other manufacturers, can grow their business by adopting quality practices and standards. We hope you enjoy this visual aid. Special thanks to Jim Moore for passing this illustration along for us to share with our readers.

ISO 9001 & Six Sigma Infographic

We are eager to receive feedback on the use of this infographic or other visual communications tools that you believe are of value. Comment below with a link on where our readers can find these additional tools. Perhaps you have a tool, blog or other message that you would like us to share with our readers in an upcoming blog? Contact us at info@cmsicharleston.com.

For more information about the ISO 9001 & Six Sigma Infographic or Midlake Products, visit them online at www.midlake.com.

ISO 9001:2015 Forum - April Webinar

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 27001 and ISO 14001). If you want to attend for ISO 9001:2015 - May Webinar register here.

Development of ISO 9001:2015

With ISO 9001 and ISO 14001 currently in the development stages for what could be rather significant changes, quality and environmental professionals gather on the fringes to get a sneak peek of what's to come. Before speculating on projected changes, let's first review the process for the development of ISO standards. Stages of Standard Development

  1. New Work Item (NWIP)
  2. Working Draft (WD)
  3. Committee Draft (CD) - Often times there may be CD1, CD2, etc. for multiple drafts
  4. Draft International Standard (DIS)
  5. Final Draft International Standard (FDIS)
  6. Published International Standard (IS), Technical Report (TR) or Technical Specification (TS)

ISO Standards Development SequenceThe current stage in which the ISO 9001 sits is at "ISO/CD 9001" as of June 3rd, 2013. This means that the document is at "CD" Stage (#3), with a due date for submission of comments and votes on this draft by September 10th, 2013. Significant chatter typically means that there could be a second or perhaps even a third round within the committee draft (CD) stage. While the expectations for release in the "IS" phase is in the year 2015 - hence the frequently referenced ISO 9001:2015 - the final release depends directly upon the voting member bodies. Publication as an "International Standard" requires approval by at least 75% of the member bodies casting a vote.

Stay tuned to the updates by registering to attend our free ISO 9001:2015 Forums.

K. Bird, Head Communication & Content Strategies for ISO posts, "Experts continue to meet to discuss any problems or questions highlighted, until a Draft International Standard is published. The draft then goes out for public comment. Anyone who is interested can contact their national member body with feedback on the draft standard. This is likely to take place during the first half of 2014."

With regard to your current use of ISO 9001:2008, Bird continues by saying "We expect to publish the new version of ISO 9001:2008 by the end of 2015. At that point there will be a transition period (usually two years) before ISO 9001:2008 officially becomes out of date."

So what are some of the projected changes that may be significant to you and your organization?

  1. The replacement of the term "product" with "goods and services". For years, service organizations (like Concentric) have felt a bit left out due to the constant use of the word "product". What if you don't have a physical product? This potential change in terminology could help service organizations better understand how ISO 9001 requirements pertain to them.
  2. Context of the term "the organization". There may be requirements to better clarify what "the organization" means as it pertains to the intent of it's offerings, the context of it's offerings, what an interested party might expect from it's goods and services, and how customer needs are defined.
  3. Process approach. This addition may require subscribers to better adopt the process approach by adding requirements that actually use the words "process approach" rather than hiding this intent in a preface or supplemental document such as ISO 9004. No one cares about how great your department is. We only care about how great your process output is.
  4. Risk vs. preventive action. This is the change that we're rooting the most for - with spirit and banter! Most folks don't really understand what the hell "preventive action" is anyway. However, "risk" is fairly well understood. Most companies we work with have hundreds of corrective actions (reactive), but very little evidence to show deliberate and methodical steps for risk reduction/mitigation or emergency preparedness (proactive). In my opinion, this change is welcome and long overdue. It would also allow for a better integration with standards in health, safety, environmental and responsible care management systems.
  5. Documented information. The terms previous referred to separately as "document" and "records" may be replaced by a single term referred to as "documented information".
  6. Control of external provision of goods and services. This potential change may not be as significant to some sectors such as automotive and aerospace, as the requirements for controlling outsources processes have been backed into ISO/TS 16949 and AS9100 for some time now. This potential addition to the ISO 9001 standard would require controls to be in place for all forms of external influences on goods and services. In short, it may be harder to say "Hey... it's my suppliers fault!" once the new standard is released.

Whatever changes do finally come from the ISO 9001 updates, we here at Concentric are very hopeful that the standard encourages organizations and practitioners alike to bridge the gap between the priorities of top management and management system implementers. Developing systems that maximize the potential of any organization is depend on a unified approach to managing individual processes. Having multiple systems, conflicting objectives and a "silo" approach to management is still one of the great challenges of our generation. I am confident that the next release of ISO 9001 will continue to improve management system structure as organizations worldwide continue to strive towards excellence.

Stay tuned to the updates by registering to attend our free ISO 9001:2015 Forums.

Turtle Diagrams

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

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.

7 Steps to Having the Best Year Ever

7 Steps to Having the Best Year Ever

Around this time every year, I take a few hours to begin my month-long+ process of reflecting on happenings and results that went right and wrong during the current calendar year.  Do I have the things I wanted to have?  Did I do the things I wanted to do?  Did I become or remain the person that I aimed to be?

The best way for me to evaluate this at the highest level is to review the top priorities I set for myself for the year.  Every year, I come up with a "theme" that is easy for me to write down and, more importantly, easy for me to recall on a regular basis.  In 2009, the theme was "The Year of the G" - girls (my wife and daughters), guitar and golf.  In 2012, the theme as been "Steep Trajectory" - quick improvements in my health, spiritual leadership in my family, personal finances and business development.

Step #1 - Creating a theme or strategy for the year is the starting point of defining and realizing your dreams.  Visualize yourself at the end of 2013 and try to capture as many details in this visualization as possible.  One great example and short exercise that is quick, simple and a lot of fun is to answer the following questions about how December 2013 looks in your dreams:

  • What do you look like in a year from now?  Are you better dressed, thinner, have that mole removed?
  • What daily habits - good and bad - will be different?  More days at at the gym that year?  Less time behind a computer?
  • Is your life more balanced than it is currently?
  • How much time and energy have you spent in helping others?
  • How active have you been in your child's life as a parent, volunteer, mentor and role model?

This morning, as I begin my visualization and commitments to 2013, I have started Step 1 by printing off an annual calendar with a monthly view.  Success in realizing your dreams is to break the dream down into actionable steps that can be taken daily, weekly, monthly or quarterly.  I often refer to this as a "Goal Converter".  See examples of how this can be applied to your organization in the Goal Converter blog from June 23, 2011 - http://cmsicharleston.com/2011/06/23/goal-converter from June 23, 2011.

Step #2 - Once you've defined the top 3-5 high level goals for 2013, print out this 2013 Calendar - Monthly View and write in the tactical steps needed to realize your goals.  Start with the simple stuff in order to gain momentum.  Here are some examples:

  • January 15th and July 15th - Schedule dentist appointments
  • Monthly budget review (pick the day that works best for you)
  • Schedule "Dude's Weekend" camping trip for the weekend after Labor Day
  • Document key birthdays, anniversaries and other events
  • Vacation planning - especially MANY MINI vacations throughout the year such as short hikes, camping, festivals, etc.

Step #3 - The next step is to keep this paper copy of the year's plan in front of you as an evergreen rough draft.  Pin it to the board near your desk or carry it in your laptop bag.  Once plans and specific dates are a bit more locked into place, enter these key events and tasks into your favorite electronic program.  I would personally recommend Google Apps in order to manage your calendar, task list, share invitations, organize email, etc.

Step #4 - Take 10-15 minutes every Friday afternoon and again on Sunday evenings to visualize the week ahead.  If you have not already, ensure you have moved all unfinished tasks to the following week.  Add new tasks to the list for the upcoming week.  By visualizing the week ahead and having a method to capture the never-ending number of to-do's, you will minimize the anxiety that can often be associated with the Sunday evening panic.

Step #5 - Take 10-15 minutes every morning to visualize your day.  I call this TWS or "Thoughts While Shaving".  Once you get into the office, or as you sit down for your money cup of coffee, ensure your daily tasks are captured and prioritized.  Make sure you include tasks outside of work such as picking up the kids, hitting the gym, picking up your dry cleaning or calling a friend.  NOTE:  Whatever you do, avoid starting your day off by checking email.  Sure, email is important.  But by starting you day with email, you allow the demands of others or irrelevant distractions to control your day.  Lock in your daily plan, begin working on critical tasks, then check emails.

Step #6 - Reward yourself for closure of individual tasks.  What works well for me is to create an empty box by each task.  Once that task is complete, I check it off.  I then go onto my Google Calendar and mark the electronic task box with a check.  I absolutely LOVE to check the box!

Step #7 - Take the time each week/month/year to go back and review all of the boxes that were checked - signifying the individual steps you took to realize your goals.  Too often (and I'm extremely bad about this), we focus on what we did NOT get done.  We do not take the time to appreciate what WAS done.  Imagine your parents doing this to you.  Don't do it to yourself.  Take the time to celebrate, study, learn and improve.

Thank you for reading this blog.  As a reward, here is a free download:  2013 Calendar - Monthly View (Editable Version)

All the best in the New Year!
-JRT

"Of all our human resources, the most precious is the desire to improve." - My latest fortune cookie

Simple Website Optimization Tips

If you are running a business in the 21st century, it is increasingly important that your website is at the top of the list when potential customers search for your products or services.  Submitting your website to top search engines is one of the quickest and simplest ways to boost your search ranking.  Did I mention that this is also FREE? Submit your website address and a short description to the following websites and watch your website climb within a matter of a few weeks:

  1. Skill Level:  Easy
  2. Time:  15 minutes
  3. Cost:  FREE
  4. Effectivity:  Moderate