Monday, 01 July 2019 20:37

Simple Tools for Chasing the Next Level

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Becoming a new nation by declaring independence, as we celebrated on the Fourth of July, was not accidental.  It was a dream that was planned and fought for.  So is the next level for any company.

Without a tangible vision and measurable milestones to achieve it, people get lost in the regular routine of daily tasks, and achieving that next level seems impossible.

This is precisely why all the ISO standards ask management to make a commitment to improvement, and dedicate a full section of the standard to the concept. Section 10.1 of ISO 9001, ISO 14001, and ISO 45001 all state “The organization shall determine opportunities for improvement and implement necessary actions”, and Section 8.5.1 of ISO 13485  states “the organization shall identify and implement any changes necessary to ensure and maintain the suitability, adequacy and effectiveness of the QMS”.  So, let’s look at a few accessible tools to make extraordinary improvements in the second half of 2019.


Breaking it down.

Identify the gaps  departmental data, customer feedback, lost sales figures are all great sources.

-Does data show an objective you are missing? Use data in employee focus groups to identify gaps and possible actions.

-Do you see a trend within customer orders, complaints or returns? Is there a common source, training need, or a missing resource that could be addressed?

-High performing companies implement 2-4 employee suggestions each year – are you collecting, investigating, prioritizing and implementing employee suggestions? Engaged employees know they are heard, and are more willing to support other company objectives.

Set priorities – Choose one or two large goals each year, and a few smaller (departmental?) goals. A culture of improvement uses the smaller goals to build momentum and enthusiasm, and carry the team through the harder or slower projects.  Balance resources so you see financial, operational and engagement returns. 

Create teams – Include those directly involved, some objective eyes from impacted departments, as well as a member of leadership to spearhead and resource. When the people closest to the project, event or policy see an issue, they need management support that their feedback and suggestions are vital.

Set goals and targets – For each project create a simple project plan, with reasonable time-based goals.  Communicate targets to the team and staff along with the reward plan for each target.

Measure and adapt – Part of keeping up the energy level on a project is measuring progress, providing resources to overcome roadblocks, and revising the plan as needed.

Celebrate – Recognition is energizing, so celebrate the small wins as well as the large ones. Rewarding teams that hit a milestone can spur on other teams, even the whole company. Whether monthly potlucks, where you regularly recognize the contributions of team members and announce next steps, or donuts and kudos on payday, a barbeque, or a gift card – pick the celebration method that motivates your team (and if you don’t know, ask!).

Saturday, 01 June 2019 20:36

Paperwork VS Risk-Based Thinking

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The 9001:2015 and 14001:2015 standards reduced the required up-front QMS documentation, based on understanding that results (not a system of documents) are what truly matter, and that some companies had been sidetracked with documentation. Now the company defines the processes they need to document to ensure consistent results, although 13485 still requires  several specific documents.


Risk Based Thinking’s  goal is to manage risk before issues occur. We all use RBT, without calling it that. For instance, crossing the street you decide whether to cross at the intersection or sprint to beat the semi, or whether to go to the gym versus staying at home in bed.


The Concept of Risk is defined as “the effect of uncertainty,” either positive or negative, and is the state of deficiency of information related to an event (ISO 9000:2015, 3.7.9).  Determining the combination of likelihood and consequence identifies the risk level. From this point of view, if you know the possible consequences of an activity, you can determine how to reduce, eliminate, mitigate, or otherwise manage the risk to product, company, or customer. Ideally all staff begin to think about work tasks using an RBT lens.


This is a philosophy of keeping in mind the upside and downside of any process or change to a process. In manufacturing, RBT means to define the risks for your company’s activities, and determine how you control those risks in each process. Then you monitor the effectiveness of your controls, analyze cause if adverse effects happen, and improve the controls as needed based on your analysis.  Rejects and complaints identify gaps in current risk controls. For more detail, see ISO 9001:2015, sections 0.1, 0.3, Annex A4 and in numerous places throughout, especially in clauses 5 and 6.


Positive Risk - Remember,  the definition of risk includes positive and negative outcomes.  So part of your RBT needs to be the identification of opportunities, and evaluation of whether it is “worth the risk” to pursue them, i.e.:  What is our likely ROI for this machine? Should we purchase vs. lease? What is the legislative impact of clients in this new industry? If we land this major client, what will we need to change to meet demand?


The Method is up to you. Whether you assign values of 1-5 for likelihood and severity and calculate risk in a formal quantitative matrix, use low medium and high values to create a qualitative matrix, or whether you simply list and discuss risk and controls in management review – the goal is to bring risk-based thinking to the surface and make it a part of your strategic planning.


One last thought – remember to review your identified risks at least annually and evaluate the effectiveness of controls, and any changes needed.

Wednesday, 01 May 2019 20:34

Even Bakers Use Process Indicators

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At a recent trade show, explaining the benefits of a quality management system to students, I described a QMS as similar to baking.  When we bake a cake, we know if we did it right by the results: texture, flavor, and appearance, compared to the ideal cake. If any of these Process Indicators is negative, it shows either the recipe, our equipment, or our process needs revising. Likewise, in daily company operations, the Key Process Indicators are as important as the products themselves – and in measuring the performance of our processes (ISO 9001:2015, 9.3.2.c.3), KPIs help us find strengths and weaknesses.

Results are the proof Each process should have one or more KPIs to show us whether we’re following the recipe (and you thought licking the bowl was only for kids!). When a breakdown in a process is not monitored, then the next process no longer meshes, impacting the whole system.

There are many KPIs available to help management verify the ‘recipe’ is accurate and effective:

-          Immediate in-process monitoring (peer review, inspections, rework data, traveler data)

-          Output (cycle-time, throughput, flow, Takt time, first pass yield)

-          Quality (In-process and final inspection, returns, reject #/causes, rework types)

-          Timeliness (On-time delivery vs. company-caused expedite delivery costs). 

-          Internal audits: not only to verify compliance to a Standard, but that the specifics in the process are followed consistently

-          External feedback from customers and external bodies (returns) can show gaps in in-process monitoring – and compliments can show effectiveness!

-          Administrative – while often ignored, administrative delays can be a prime contributor to achieving overall objectives and customer satisfaction. Common measurable indicators include:

o   number of follow-ups needed to get additional specifications or paperwork;

o   programming accuracy/rework rates,

o   response time on quotes or questions,

o   win/loss ratios on sales (by sector, cause)

o   on-time material availability,

o   delivery cost containment;

o   communication on errors/delays,

o   data accuracy on production processes

o   Record accuracy/completeness (risk, certifications, maintenance, maintenance, training, corrective actions, internal audit evidence)

 Improving the Recipe:  One way to ‘continually improve’ is once a month to ask the team about a process they think needs improvement, then create a workgroup to review and rewrite it. As you do, make sure it has KPI’s that reflect its nature and place in your system.

Friday, 05 April 2019 20:29

Management Review: Brexit-Style or Fusion?

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Management Review: Brexit-Style or Fusion?           

Like its flag, the UK is a blend of many cultures, but for the last 2 years, the British Parliament has been stuck on the hamster wheel of Brexit, voting over and over on similar options.

Does this sound like some of your Management Review meetings?
We hope not! Here is a recipe with some ideas to keep reviews fresh and useful:

Meals vs Banquets: While 4-8 hour annual strategic planning is critical,
short meetings (2-4 times/year during transitions or when issues are hot) are less overwhelming. A 1-hour meeting to review progress is still a meeting.

Recipe is essential: over the year, you must include all the ingredients in Inputs (9.3.2) and Outputs (9.3.3).

Repeat leftovers are BORING. Decisions from the last meeting (9.3.2.a) only need review if not finished or effective.

Fold, not Beat: Management’s job is strategic. Instead of a twenty-minute discussion interpreting raw data (like each vendor or each return) use annualized trends (9.3.2.c-f) to see issues affecting company performance.

Serve proportionately: Make decisions and assign work with clear measurable objectives and timelines, for each department’s responsibilities.

Share the recipe: Congratulations! You’ve met and planned actions for improvements. Let the whole staff know where you’re headed, solicit their questions or suggestions, and recognize contributions and achievements.

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