simple tools

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 & 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.

Writing a Nonconformance (NCR)

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

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

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

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

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

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

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

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

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

Nonconformance Report (NCR)

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

Cheers,

Jim Blog Signature

Turtle Diagrams

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

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