Curing Lean Six Sigma Weak Points

The following question was asked on LinkedIn by Bill Rushmore, Principal at Rushmore Technologies, a degreed Chemist and Engineer:

For those who have experience with Six Sigma or Lean Sigma, what is the one (or two) weak point(s) that you would fix with a Six Sigma or Six Sigma project? I am looking into how to improve Lean Six Sigma and have my own factors. I am looking for other opinions or experiences to expand the possibilities.

Diane Kulisek’s answer, one of many posted, was selected by Bill as the ‘Best’ Answer.  Here it is:

I think two things need to change:

• 1.) There needs to be less emphasis upon the correctness of the terms used to describe what is being done and more emphasis upon doing it; and
•  2.) There needs to be less elitism associated with those accountable for employing the methodology.

Let me say I believe that Six Sigma and Lean will continue to be terms used for at least the next five to ten years, however, I also have started to hear many of the same criticisms of “Six Sigma” and “Lean” that I used to hear in relation to “SPC”, “Quality Circles”, CPI and “TQM”. All six of these terms (Six Sigma, Lean, SPC, Quality Circles, CPI and TQM) entail top management support, problem-solving methodologies, process improvement tools, and, potentially, improved value or economy. All six of these terms could also be costly to implement. All six of these terms are subject to failure during top management changes. All six of these terms also, unfortunately, can be categorized as “fads”. When you peel back the glitzy layer of names, they are all essentially the same thing. You can garble them up with new terms to describe old concepts. You can claim that they do things differently from one another (which they certainly do, slightly). You can say that the next one made the previous one “obsolete” or old-fashioned (which is not necessarily the case)…. but the bottom line is, they all have so much in common that you can pretty much expect Six Sigma and Lean to take a nose dive the minute enough negative momentum about “THOSE words” has been achieved…. and it’s on it’s way.

My advice would be to stop using trendy words like “Six Sigma” or “Lean” and talk about the fundamental tools being used. More people will understand and the continuity will be better through the turmoil of management changes. So, that’s the language aspect of it.

Secondly, business managers were taught to beat the “quality-is-everybody’s- responsibility” drum for decades. Then, along came Six Sigma. Only the best/brightest were drafted into the Six Sigma ranks. Their grasp of finance needed to be as great (or greater than) their grasp of technology or methodology. They were subjected to extremely expensive (often) company-sponsored training programs…. out of which they emerged, with the green beret of the Six Sigma special forces. Proud and overly confident, many freshly-belted (pun intended) Six Sigma initiates blundered out into the production workspace only to be shot down by older, wiser and angrier personnel lurking in sniper positions.

 The elite division of class that is so often identified with the “Six Sigma” black belt mystique has created far more problems, in my opinion, than have been solved. In fact, I would venture to say that there are more people working to be sure a Six Sigma Black Belt falls smack dab on his or her nose than there will ever be willing to help them in an otherwise just cause. The problem is that nobody likes to be treated as a “lesser than”. Six Sigma Black Belts (and even other belt designations) seem to be taught a smugness that acts like a bullseye on their butt cheeks and foreheads.

My recommendation would be to get rid of the title. Again, focus upon the fundamental tasks being performed. Define the roles from the perspective of basic tasks. “You will be accountable for improving the performance of this process. Accordingly, you are henceforth our Process Improvement Project Manager.” EVERYbody can understand what THAT is.   Well okay, maybe not everybody…  but more than understand ’six sigma black belt’.

What is a “Six Sigma Black Belt”? It’s an abstraction, especially for those who have NOT (nor likely ever will) been through the training to become one. Why create mystery where openness is the key to improvement? Why create an “elite class” when collaboration at all levels of the organization will be essential to creating desired change? It’s counter-productive, at best. Drive out the use of the terms “Six Sigma and Black Belt”. Use role definitions and job titles that EVERYBODY can understand… and support.

Postscript from Diane:  I suppose it might be worth mentioning that I’m actually starting to see the word ‘quality’ reappear in job descriptions, perhaps not in the titles, but in the responsibilities.  People in charge of hiring people who need to know how to use quality improvement tools and methods have not yet become quite bold enough to venture that a rose is a rose by any other name, but they have begun using ‘other’ terms to avoid using “six sigma’, ‘lean’ or ‘lean sigma’ in many of the more recent position descriptions I’ve been seeing on the open job market.  Examples of ‘new’ quality-related titles include: “Continuous Improvement Project Manager”, “V.P. Organizational Excellence” and “Director of Business Performance Reporting”.  It is …. a start.

Measure or Metric? Six of One, Half Dozen of the Other?

Here is another LinkedIn ‘Best Answer’.  Anshuman Tiwari, a Change Management and Business Excellence Professional within the Information and Technology Services industry and  an active member of the American Society for Quality in India, asked the following LinkedIn Question:

“How would you differentiate between Measure and Metric?  Measure and Metric are often used terms in Balanced Scorecard and the Baldrige framework. How would you explain the difference. Do you have any examples?”

Below is the answer I posted, which Anshuman rated as the ‘Best’ answer of six provided by LinkedIn Members:

“The only distinction that I think might be able to be made does not appear to be available in any of the literature I’ve checked. I’m basing this only upon my personal experience.

I would have to say that a measure is usually performed to gather information for later analysis or to assess conformance with a known specification.

Meanwhile, I would say that a metric is a collection of measurements performed consecutively over a period of time (or in relation to some other progressive scale) that reflects ongoing performance toward attainment of a desired goal or ultimate outcome. Some measures, however, may also appear in analysis of priority or importance with regard to attainment of a goal or may influence allocation of resources for ultimate attainment of a goal (such as might be the case for cumulative Pareto analysis or 80-20 Rule determinations).

In a nutshell, then, I would have to say that a measure tends to be tactical and a metric tends to be strategic.

It certainly should be defined somewhere, officially.”

This was not part of my LinkedIn Answer, but below are the Google-derived definitions of ‘measure’:

Related phrases:   performance measure   unit of measure   made to measure   common measure   tape measure   oregon ballot measure 7   measure for measure   beyond measure   linear measure   how to measure a planet

Definitions of measure on the Web:

• any maneuver made as part of progress toward a goal; “the situation called for strong measures”; “the police took steps to reduce crime”
• how much there is or how many there are of something that you can quantify
• bill: a statute in draft before it becomes law; “they held a public hearing on the bill”
• measurement: the act or process of assigning numbers to phenomena according to a rule; “the measurements were carefully done”; “his mental measurings proved remarkably accurate”
• standard: a basis for comparison; a reference point against which other things can be evaluated; “the schools comply with federal standards”; “they set the measure for all subsequent work”
• determine the measurements of something or somebody, take measurements of; “Measure the length of the wall”
• meter: (prosody) the accent in a metrical foot of verse
• quantify: express as a number or measure or quantity; “Can you quantify your results?”
• musical notation for a repeating pattern of musical beats; “the orchestra omitted the last twelve bars of the song”
• have certain dimensions; “This table surfaces measures 20inches by 36 inches”
• measuring stick: measuring instrument having a sequence of marks at regular intervals; used as a reference in making measurements
• evaluate or estimate the nature, quality, ability, extent, or significance of; “I will have the family jewels appraised by a professional”; “access all the factors when taking a risk”
• a container of some standard capacity that is used to obtain fixed amounts of a substance
  wordnetweb.princeton.edu/perl/webwn
• Measure is the second album from Matt Pond PA, released in 2000.
  en.wikipedia.org/wiki/Measure_(album)
• A jigger or measure is a bartending tool used to measure liquor, which is typically then poured into a cocktail shaker. It is named for the unit of liquid it typically measures, a 1.5 fluid ounce (~44 ml) jigger or shot. …
  en.wikipedia.org/wiki/Measure_(bartending)

If we narrow our search for a definition to ‘performance measure’, we’ll find that ‘measure’ and ‘metric’ are terms used interchangeably.  There are subsearches provided for strategic performance measures and for tactical performance measures, however.  Here are the Google-based ‘performance measure’ definitions:

Related phrases:   technical performance measure   strategic performance measure   tactical performance measure   performance measure/indicator

Definitions of performance measure on the Web:

• A quantifiable measure to assess how well the organization carries out specific functions or processes.
  nyrxreport.ncqa.org/Glossary.aspx
• A characteristic or metric that can be used to assess the performance aspects of a program or project (ie, dollars expended, students enrolled, grade- point average, number of job offers received).
  www.ed.gov/fund/grant/about/grantmaking/glossary.html
• Ways to objectively measure the degree of success a program has had in achieving its stated objectives, goals, and planned program activities.
  www.epa.gov/evaluate/glossary/p-esd.htm
• A particular value or characteristic designated to measure input, output, outcome, efficiency, or effectiveness.
  www.f5ac.org/mguide/GlossaryFinal.htm
• an indicator.
  www.ameteam.ca/glossary.html
• A performance measure is an integral part of both compacts and strategic plans. A performance measure is a management tool that measures progress and results achieved. Performance measures are the proof of success or failure. …
  www.tamus.edu/strategicplan/docs/GLOSSARY.doc
• A qualitative or quantitative measure of outcomes, outputs, efficiency, or cost-effectiveness. In general, measures should be related to an organization’s mission and programs, and should not merely measure one-time or short-term activities.
  ops.fhwa.dot.gov/freight/publications/ftat_user_guide/sec5.htm
• a statement specifying clearly and precisely a desired output, outcome, or event that is expected to occur: the “what” that is to be measured.
  www.scoea.bc.ca/glossary2001.htm
• An indicator of an agency’s achievement of desired outcomes. For the past year, most state agencies have tracked three to five measures that relate to the agency’s mission, most critical activities, or largest budgetary items. Institutions of higher education have additional measures. …
  dpb.virginia.gov/Budget/00-02/buddoc00/glossary.cfm
• A particular value or characteristic used to measure/examine a result or performance criteria; may be expressed in a qualitative or quantitative way.
  www.uwex.edu/ces/tobaccoeval/glossary.html
• A measurement statement of activity, process or outcome.
  www.spotsylvania.va.us/departments/countyadmin/index.cfm
• A quantitative or qualitative tool to assess progress towards an outcome or goal.
  www.iowadot.gov/railplan/glossary.htm
• A yardstick or standard used to measure progress toward achieving a strategic objective or a tactical objective. …
  www.blackerbyassoc.com/SPGloss.html
• Special quantitative and qualitative measure of work performed as an objective of a department.
  www.cityofmacon.net/business/budgetglossary2.htm
• an indicator used to evaluate progress towards business goals and objectives usually measured against a target or known standard
  www.cecausa.com/business_process_glossary.htm

So, for ‘tactical performance measure’ we have the following Google-based definition:

A yardstick or standard used to measure progress toward achieving a tactical objective; a measure of how well we are doing; an output measure or a …
www.blackerbyassoc.com/SPGloss.html

And, for ‘strategic performance measure’ we have this:

A yardstick or standard used to measure progress toward achieving a strategic objective. a measure of how well we are doing; an outcome measure.
www.blackerbyassoc.com/SPGloss.html

Hmmm….. those look…. suspiciously… like the exact same definition.  Let’s see what the Google-based definitions are for ‘metric’:

Related phrases:   metric ton   metric system   metric space   metric structure   metric conversions   metric units   metric tonne   routing metric   euclidean metric

Definitions of metric on the Web:

• metric function: a function of a topological space that gives, for any two points in the space, a value equal to the distance between them
• metric unit: a decimal unit of measurement of the metric system (based on meters and kilograms and seconds); “convert all the measurements to metric units”; “it is easier to work in metric”
• system of measurement: a system of related measures that facilitates the quantification of some particular characteristic
• measured: the rhythmic arrangement of syllables
  wordnetweb.princeton.edu/perl/webwn
• Metric is a Canadian New Wave/indie rock band. Originally formed in 1998 in New York City, they are currently based in Toronto, Ontario, Montreal …
  en.wikipedia.org/wiki/Metric_(band)
• In differential geometry, the notion of a metric tensor can be extended to an arbitrary vector bundle. …
  en.wikipedia.org/wiki/Metric_(vector_bundle)
• In general relativity, the metric tensor (or simply, the metric) is the fundamental object of study. It may loosely be thought of as a generalization of the gravitational field familiar from Newtonian gravitation. …
  en.wikipedia.org/wiki/Metric_(general_relativity)
• A metric is a standard unit of measure, such as meter or mile for length, or gram or ton for weight, or more generally, part of a system of parameters, or systems of measurement, or a set of ways of quantitatively and periodically measuring, assessing, controlling or selecting a person, process …
  en.wikipedia.org/wiki/Metric_(unit)
• A measure for something; a means of deriving a quantitative measurement or approximation for otherwise qualitative phenomena (esp. …
  en.wiktionary.org/wiki/metric
• metrics – prosody: the study of poetic meter and the art of versification
  wordnetweb.princeton.edu/perl/webwn
• Metrics is a property of a route in computer networking, consisting of any value used by routing algorithms to determine whether one route should perform better than another (the route with the lowest metric is the preferred route). …
  en.wikipedia.org/wiki/Metrics_(networking)
• Measurable element of a service, process or function. The real value of metrics is seen in their change over time. Reliance on a single metric is not advised, especially if it has the potential to affect User behaviour in an undesirable way.
  www.infodiv.unimelb.edu.au/knowledgebase/itservices/a-z/m.html
• A standard of measurement. Software metrics are the statistics describing the structure or content of a program. A metric should be a real objective measurement of something such as number of bugs per lines of code.
  www.software-testing-outsourcing.com/glossary.html
• A general term describing a measurable value available from a particular system or service (see also Counters). The metrics that are available depend on the monitor type and configuration of the system. …
  mon15ny450.doubleclick.net/SiteScope/docs/SiteScopeTerms.htm
• A standard for measurement.
  www.icaa.cc/member_wellnessworkgroups/benchmarks_workgroup/Benchmarks%20Definitions%20Worksheet.doc

Defining the word ‘metric’ seems to use the term ‘measure’, a lot.  I dunno.  What do YOU think the differences are between a metric and a measure?

While you’re pondering that, feel free to download copies of my presentation handout about Quality Metrics and Dashboards from the CAPAtrak Website or enjoy the free downloadable Simple Dashboard and Balanced Scorecard Templates.

ISO Publishes New Standard for Effective Risk Management

Complemented with risk management vocabulary guide

 (ISO: Geneva) — A new international standard, ISO 31000:2009—“Risk management—Principles and guidelines,” will help organizations of all types and sizes to manage risk effectively.

ISO 31000 provides principles, framework, and a process for managing any form of risk in a transparent, systematic, and credible manner within any scope or context.

At the same time, ISO is publishing ISO Guide 73:2009—“Risk management vocabulary,” which complements ISO 31000 by providing a collection of terms and definitions relating to the risk management.

“All organizations, no matter how big or small, face internal and external factors that create uncertainty on whether they will be able to achieve their objectives. The effect of this uncertainty is ‘risk’ and it is inherent in all activities,” explains Kevin W. Knight, chair of the ISO working group that developed the standard.  “In fact, it can be argued that the global financial crisis resulted from the failure of boards and executive management to effectively manage risk. ISO 31000 is expected to help industry and commerce, public and private, to confidently emerge from the crisis,” continues Knight.

The standard recommends that organizations develop, implement, and continuously improve a risk management framework as an integral component of their management system. “ISO 31000 is a practical document that seeks to assist organizations in developing their own approach to the management of risk,” says Knight. “But this is not a standard that organizations can seek certification to. By implementing ISO 31000, organizations can compare their risk management practices with an internationally recognized benchmark, providing sound principles for effective management. ISO Guide 73 will further ensure that all organizations are on the same page when talking about risk.”

ISO 31000 is designed to help organizations:

• Increase the likelihood of achieving objectives
• Encourage proactive management
• Be aware of the need to identify and treat risk throughout the organization
• Improve the identification of opportunities and threats
• Comply with relevant legal and regulatory requirements and international norms
• Improve financial reporting
• Improve governance
• Improve stakeholder confidence and trust
• Establish a reliable basis for decision making and planning
• Improve controls
• Effectively allocate and use resources for risk treatment
• Improve operational effectiveness and efficiency
• Enhance health and safety performance, as well as environmental protection
• Improve loss prevention and incident management
• Minimize losses
• Improve organizational learning
• Improve organizational resilience

ISO 31000 and ISO Guide 73 can be applied to any public, private, or community enterprise, association, group, or individual.   The documents will be useful to:

• Those responsible for implementing risk management within their organizations
• Those who need to ensure that an organization manages risk
• Those needing to evaluate an organization’s practices in managing risk
• Developers of standards, guides, procedures, and codes of practice relating to the management of risk

Both documents were developed by the ISO working group on risk management.  For additional information, please visit the ISO website at: http://www.iso.org/iso/pressrelease.htm?refid=Ref1266.

What Are the Benefits of Healthcare Business Process Management (BPM)?

This question (a collection of questions, actually) was posted on LinkedIn by Yousef Mahmoud, PMP, a business process management consultant with EJADA Systems in Saudi Arabia. (http://www.linkedin.com/in/yousefmahd ):

What are the added values to health care organizations gained through Business Process Management with respect to incorporating standards and Quality means?  What are the standards and certificates available for health care org?  ISO?  What GCI for health care institutes?  How can BPM initiatives help health care org apply these standards efficiently?

Diane Kulisek’s Answer (selected as the ‘best’ of two ‘good’ answers posted on LinkedIn):

Quality Management is, in my opinion, at it’s most effective when managed as a system of interrelated processes. Standards are helpful in establishing a Quality Management System (QMS) because, typically, those who develop the standards are world class experts within the industries they represent and for whom the standards are intended to be effective. The standards such people develop take into consideration practicality as well as intangible values (which may matter most to customers and stakeholders).

The value of a Quality Management System, regardless of what standard or criterion might be used, is that it provides a basis for determining the overall effectiveness of multiple processes critical to effective provision of customer (patient) care and while strategically, proactively, addressing the needs of stakeholders (financial resources). Having a quality management system in place better assures that anticipated potential but unplanned expenses related to poor quality have been effectively mitigated (i.e. to prevent or reduce the potential for malpractice and liability related expenses).

I have found that there is also value with regard to improved employee retention and morale by having the solid foundation of a top management supported system to inspire continual process and service improvement on a company-wide (or health care facility-wide) basis.

With regard to what standards or certificates might be available for health care, I recommend you contact the American Society for Quality’s Healthcare Division (http://www.asq.org/health/ ) for the latest developments. Another source of guidance that may be of value to you is the Baldrige National Quality Program’s “Health Care Criteria for Performance Excellence”.   A .pdf copy of these guidelines is available from the NIST (National Institute of Standards and Technology) at http://www.baldrige.nist.gov/HealthCare_Criteria.htm . You may also request that a hardcopy be mailed to you from that website.

I believe these resources could be helpful to any nation’s health care improvement efforts and they are certainly available to you via the internet.

Diane’s LinkedIn Answer about Environmental Reporting, Metrics and Data

This question, which is actually a collection of questions, about “Environmental reporting – defining metrics, retrieving data from data warehouses or other data sources” was posted on LinkedIn by colleague Lauchlan Mackinnon, Ph.D., a specialist in the areas of creative thinking, innovation, value creation and change management.  The question(s) was (were) answered by Diane Kulisek and hers was selected as the ‘best’ answer byDr. Mackinnon. 

Here are the elements of the question:

• What models are you using for environmental reporting to define the metrics to report against, retrieve the data, and report on it?
• Which frameworks and approaches do you find most useful?
• What is your strategy for defining the appropriate environmental reporting metrics?
  • Are these metrics mandated by reporting standards (and if so, how so?); or
  • do you have considerable freedom and flexibility in defining them in the way that best suits the company the reporting is being done for?
• I would also appreciate any specific advice regarding to what extent you can retrieve the required data from existing data warehouses / data stores, or you need to define and collect new streams of data to report effectively.
• Also, to what extent do you tie this reporting with other existing reporting (e.g. balanced scorecard) and to what extent do you treat environmental reporting as a seperate reporting task (e.g. a compliance obligation as seperate to busines operations management)? It would make sense to me to integrate the two, but I want to see what you think . . .Any references to specific approaches you use or standards and frameworks you find particularly useful will be appreciated.

Diane’s Answer(s):

Those are a lot of questions to ask at once and, were I sitting down to discuss this with you 1-to-1, I’d need a lot of clarification to feel as though I could really do the answers justice. That being said, I would like to tackle a few aspects of your questions to start with and recommend that you narrow the scope of your inquiry for further dialogue.

Firstly, on the matter of strategy definition, standards may be an important consideration, especially if a standard is contractually imposed or imposed via a regulatory agency. The standard series with which I am most familiar is strictly for physical environments: ISO 14000. You can obtain a copy of it and related standards from the American National Standards Institute (ANSI).  These documents are not cheap.

Some companies have begun adopting a “green” posture for public relations, as well. If this is the case, I recommend that an environmental “policy statement” be developed and that each element of that statement be broken into discrete components of the organization’s overall strategic plan. For each such element, key performance indicators will need to be defined that are either variably measurable or attainable as an attribute (go/no go, did/didn’t, etc.). Each such metric should then be flowed into each operating policy and/or procedure that can generate any part of it throughout the operation. The personnel doing the work can be trained in the use of dashboards to monitor their own contribution toward attaining the strategic objectives. Dashboard data would typically be rolled upward into the balanced scorecard at the organization-wide level.

If you are working in something other than a physical environment, per se (i.e. a software development environment, financial environment, etc.), you may want to manage things quite differently and, certainly, you should be able to link to automated streams of data to fill out real-time metrics compilers for much more complex, live, intranet-hosted reporting.

I saw a nice example of a streaming data financial dashboard on a website that compiles such examples recently. [Edit:  The example was on DashboardSpy.com, a great resource].   I believe I copied a link for it into a free presentation handout available through my company website under the “downloads and links” tab (www.capatrak.com).  The presentation is titled: “Quality Metrics, [Scorecards] and Dashboards“. My expertise is in quality management and regulatory affairs, so you might need to temper your expectations a bit with regard to applicability for environmental management and regulation. The same information should also be useful for the environmental management side of the world, however. If you don’t mind tailoring them for your use, there are also free downloadable, editable, Excel-based balanced scorecard and simple dashboard templates for you there. I’ve also got an example of a strategic plan and a very simple MS Word based editable template for a strategic plan there… but they are intended for quality endeavors and would be derived from an organization’s quality mission statement as opposed to an environmental policy. It shouldn’t be hard to make the necessary modifications for them to work with an environmental policy, however.

Quality-Related Answers on LinkedIn from Diane

As I was updating some of my information on LinkedIn this morning, it occurred to me that I’ve shared much more information about quality there than on this blog.  While I want to keep the information I share here fresh, sometimes I’m a bit too busy with other urgent matters to compose a new message.  In cases like that, I think you might find some of the answers I’ve posted on LinkedIn of interest… especially those that have been rated highly by LinkedIn users.

Before I get into that, here are a few facts about my LinkedIn activities to help put things into perspective. 

I joined LinkedIn on April 30th, 2006.  Today, I have 365 first degree connections (people I personally know and who are connected directly to me through LinkedIn), 162,200+ second degree connections (people who know people connected to me), and 6,814,700+ third level connections (people who know people who are connected to me), for a total LinkedIn network of 6,977,300+ people.  My LinkedIn network has grown by 30,677 people in the past week.    

Members of my nearly 7 million person network are from all over the world but are largely located in New York, San Francisco, India and Los Angeles, each with 5% of my total LinkedIn network membership, and Chicago, with 3% (for a collective total of 23%).  That means that roughly 200,000 to 350,000 people in each of 4 major U.S. cities and in India are accessible through my network… and can interact with me… via LinkedIn Answers.  India, Los Angeles and London are my fastest growing LinkedIn network regions.

Many of my direct LinkedIn connections are in quality-related professions, however, there is no ‘quality’ profession category to identify oneself with on LinkedIn (and, yes, I’ve mentioned this to LinkedIn’s management team), so 38% of the industry-categorized members of my LinkedIn community currently fall into the following fields: 

14% Information Technology and Services;

07% Staffing & Recruiting (no surprise there, eh?);

06% Management Consulting (a.k.a. ‘previously employed’, also not a surprise);

06% Computer Software (a.k.a. Information Technology and Services – the sequel); and

05% Human Resources (a.k.a. ‘Staffing & Recruiting’ – part deux).

 

I change my LinkedIn industry category declaration to suit my circumstances or my mood.  I’ve used ‘management consulting’, ‘medical device manufacturing’, ‘process industries’, ‘electrical and electronics’, ‘government relations’ and, currently, ‘public safety’.  They’re all true, of course, or were at the time I used them.

I’ve also changed my title, to suit my mood.  Currently, I bill myself as: “Organizational Excellence and Quality Assurance Leader”.  I used to be a “Senior Quality Professional” until I read that “Senior” means “Old” on a resume.  Then I was just a “Quality Professional”, until somebody mentioned (rightly) that all professionals are (or should be) quality professionals.  Then I was a “Quality Assurance Professional”, until another person pointed out that, since Lean and Six Sigma has been around, people don’t hire actual “Quality Assurance Professionals”, anymore.  So, I compromised with kind of a play off of the American Society for Quality’s Certification Designation for a Quality Assurance Manager:  “Manager of Quality / Organizational Excellence” and changed the word “Manager” to “Leader” (mostly to try to stop people from sending me first level management job leads — which don’t seem to work very well for me).  I’m now calling myself an “Organizational Excellence and Quality Assurance Leader”.  I think I need to drop “Assurance” and change it to “Improvement”.  The word “Assurance” is apparently still somewhat politically incorrect, in the current job market.  I’ll do that today.

Anyway, continuing on… according to LinkedIn… I’ve posted 175 answers, as of today.  Unfortunately, not all of those who ask questions on LinkedIn rate the answers they receive (which is really just a form of thanks for those of us who took the time to answer), but for those of my posted answers that were rated, 70 were considered ‘good’ or ‘best’, with 32 falling into the ‘good’ rating and 38 into the ‘best’ answer rating.  23 of the ‘best’ answers I’ve posted are in relation to the topic: “Quality Management and Standards”, but there are many other answer categories that I’ve provided ‘best’ answers for.  Following is the LinkedIn breakout of my ‘best’ answers by topic: 

• Quality Management and Standards (23 best answers)
• Organizational Development (2 best answers)
• Manufacturing (2 best answers)
• Project Management (2 best answers)
• Supply Chain Management (2 best answers)
• Certification and Licenses (1 best answer)
• Mentoring (1 best answer)
• Event Marketing and Promotions (1 best answer)
• Personnel Policies (1 best answer)
• Business Analytics (1 best answer)
• Corporate Governance (1 best answer)
• Labor Relations (1 best answer)
• Inventory Management (1 best answer)
• Career Management (1 best answer)
• Professional Organizations (1 best answer)
• Ethics (1 best answer)
• Starting Up (1 best answer)
• E-Commerce (1 best answer)
• Computers and Software (1 best answer)
• Using LinkedIn (1 best answer)

What this means for you is simply this: out of my nearly 7,000,000 member LinkedIn Network, I am, by far and away, the top rated ‘expert’ on “Quality Management and Standards”.  I must be doing something right.  I don’t like to describe myself (or anybody else) as an ‘expert’, but LinkedIn does that based upon the highest number of ‘best answer’ ratings. 

Here is how being an ‘expert’ looks on the Answers page (at the bottom) for this topic: 

In case you’re thinking the apparently huge ‘best’ answers lead I seem to have over fellow professionals, like close runner up, Anshuman Tiwari, does not take into account the expertise of my 2nd degree or 3rd degree LinkedIn contacts, take a look at this:

Yeah, Shaun (2nd degree connection) and Scott (3rd degree connection), ‘expert’ front runners, are snapping at my heels (NOT). 

And, by the way, I only post one or two LinkedIn Answers per week… so I don’t spend a lot of time doing this.  I find providing answers on LinkedIn challenges me and keeps my mind tuned into the latest developments in my chosen profession, so I do it for my ongoing personal and professional development as much as for others.  It takes me about an hour (usually) to research and prepare one ‘best’ answer.   That is not a huge investment for my return on it.

So… the point of this shameless bragging about my LinkedIn activities and answers is this:  maybe I’ve posted some answers that would be worthwhile for you to read.

I recognize that finding past answers I’ve posted to support your more urgent needs or interests might be like looking for a needle in a haystack via LinkedIn, especially if you don’t have a LinkedIn account (although Google is doing better at providing this information, now).  Nonetheless, I’m going to start posting some of the better answers I’ve provided here, too.  I do provide plenty of links to the LinkedIn website here, so let’s figure this might inspire some of my blog readers to open a new LinkedIn account (or better use the one they have), shall we?  It’s a win-win-win. 

Anyway, my future LinkedIn Answer Blog posts here will be titled in a manner that best represents the original question asked.  The entire content of the question will appear in the body of the post. 

If you have any questions for me about LinkedIn, I’ll be happy to do my best to answer them for you.  Better yet… join LinkedIn and ask me there!

ISO 9001 Management Review Agenda Template

Click Image to Download

This editable MS Word template addresses the agenda ‘inputs’ required by ISO 9001 and can be downloaded immediately.  No request form needs to be filled out.  Just click HERE or on the image of the template.

One of the basic requirements of ISO 9001:2008 is that a Formal (documented) Top Management Review of the Quality Management System be held at planned intervals (reference: Section 5.6 of the standard).  It is typical for third party assessors to require a planned interval of: ‘at least once per year’.  

There are specific ‘review inputs’ (topics and accompanying data) that must be addressed during the review in order to comply with the standard… and there are specific ‘review outputs’ (outcomes, including actions) that must be achieved. 

For a list of all records required by ISO 9001:2008, visit the ISO website and take a look at the table at the bottom of ISO/TC 176/SC 2/N525R2, “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008″  titled: “Annex B: Records Required by ISO 9001:2008″.

While the agenda for the Management Review is clearly prescribed within the ISO 9001 Standard, the formats for the supporting documentation, or effectiveness thereof, are not.  One company I worked with had identified exactly the same critical resource need to support quality outcomes for over five consecutive years … and had not made any effective progress in addressing that need.  Every year, the inadequacy of the Corrective Action System was noted in the minutes of the Management Review.  Every year, the third party assessor had also cited a ‘minor’ finding against the Corrective Action System.  Still, five years in a row, not a single improvement had been made to the Corrective Action System.  This did not prevent the company from maintaining ISO 9001 certification, however, because the minimum requirements of the standard were met.

It may be tempting to pay lip service to a requirement for continual improvement just long enough to pass a third party assessment, but the damage caused by the dishonesty or insincerity of top managers can potentially cause far more damage to an organization than the cost, if any, of diligent, steady, practical, incremental, improvements over time. 

The difficulty of allocating precious few resources to a system that does not seem too badly ’broken’, especially in a tough economy, is understandable.  In my opinion, however, the cost is not always the issue.  Although pie-in-the-sky promises are often well-intended, the real challenge can be not to bite off more than the organization can chew, so to speak.  Overly ambitious plans for improvement fail as surely as dishonest ones.  Limiting planned improvement efforts to what is practical, instead of what might be possible or what is wished for, can still provide steady improvements that support positive change over time. 

I recommend a conservative approach to addressing resource needs that arise in Management Reviews.  Many organizations hold monthly or quarterly operations reviews.  Why not address the requirements of the ISO 9001 Management Review in meetings that occur more naturally and routinely for your organization?  Make a conscious team effort to manage required Quality Management System resource allocations and actions as part of the normal way you do business.

Whatever the frequency of your Management Reviews might be, the template provided will empower you to assure each required agenda item and outcome is addressed in compliance with the ISO 9001 standard. 

If this particular Management Review Agenda Template doesn’t seem to work well for your specific needs, try using Google to do a search for others.  I got 537 MS Word document hits when I entered this search string:  ”iso 9001 management review agenda template filetype:doc“

As always, if you need a particular template, metric, form or advice on any other quality-related matter, feel free to contact me.  I’ll be happy to do what I can to help.

Simple CAPA Status by Manager Metric Template

Today’s template is one I created for use in reporting Corrective and Preventive Action (CAPA) status (opened, closed, backlog) by manager.  If you’re in a hurry, you can click on the image to the left to request this Quality Resource, now.

The availability of sophisticated, enterprise-level, CAPA tracking and performance reporting systems is great … if you can afford them … and if you can afford to maintain them.  Unfortunately, that appears to be getting more difficult to do and, in my experience, has not often been the case.  A poorly maintained system can be (and often has been) worse than no system at all.

What to do?  Well, start small and work with tools that are familiar and easily accessible to everybody… like MS Excel.  Get the biggest bang you can for your buck. 

I have found that heightening personal accountability for timely completion of assigned corrective or preventive actions, by publishing the status of CAPA’s assigned to each person in an organization, can result in some pretty impressive returns on investment. 

For a small to medium sized company, this isn’t too hard to do using an MS Excel spreadsheet, such as the one provided here.  You can customize the reporting frequency interval to work best for you, but tracking by month has been a pretty effective way for most companies I’ve worked with to go.  If you’ve got a relatively high volume of CAPA activity, try weekly status updates.  If you hardly ever need to improve anything (because you’re just THAT good), go with a quarterly report.  You might even be able to get away with generating only a twice yearly or annual report for use in your Management Reviews.

If identifying people by name or title on a performance chart seems as though it may not be suitable for your organization, try using department names or product names, instead.

For each reporting interval, the template provided will empower you to graphically display the level of CAPA’s initiated to, closed by or in the backlog for each assigned person or group. 

There are as many ways to do this as there are people wanting to do it, of course.  You may prefer to switch to a classic Six Sigma Dashboard style and, if that’s the case, Dashboard Spy has a nifty example for you (click here).  If you’d like the software to do what you see on Dashboard Spy using Excel, consider QI Macros, one of my favorite salt-of-the-earth applications.  I’ve created a template for a Simple Quality Dashboard  using QI Macros.  The Simple Quality Dashboard template is always available for download on the CAPAtrak Website and I’ve seen it in use in many companies I’ve visited. 

If this particular ”Simple CAPA Status by Manager Template” doesn’t seem to work well for your specific needs, try using Google to do a search for others.  I got 25 MS Excel spreadsheet hits when I entered this search string:  ”capa status dashboard filetype: xls“.  

As always, if you need a particular form or advice on any other quality-related matter, feel free to contact me.  I’ll be happy to do what I can to help.

Document Change/Release Order (MS Word)

Today, I dug around in my goodie bag and came up with this Document Change/Release Order template.  If you’re in a hurry, you can click on the image to the left to request this Quality Resource, now.  It is a fully-editable MS Word document.  You can add a company logo, delete an approval block, change a document category, or do whatever else best suits your purpose.  This type of document is also often referred to as an Engineering Change Order or Request (ECO or ECR). I prefer to use the term “Document” instead of “Engineering” because not all documents requiring control for an effective Quality Management System are Engineering documents.  It may not be perfect, but it has passed many an audit by ISO 9001 registrars. 

Every company I go to work for seems to struggle with how best to manage the change process for their documents.  All would like a simpler, faster way to do it.  I’ve tried automating the process using the MS Outlook features for collaborative review.  There is a Microsoft Partner application called Workshare that looks pretty good for this.   At one company, we used Carmen, a document control application from another Microsoft Partner, Manedge Software.  That was very affordable and worked well, too.  If you’re in a larger organization, it might be worthwhile to invest in some of the more sophisticated enterprise solutions for document control, such as those provided by MasterControl.  There are certainly more applications available, but these are the ones I’m familiar enough with to tell you about. 

I should probably mention that the ERP modules for document control that I’ve seen do not seem to work very well.  They’re just a bit too easy for the average employee to hack around.  I’m not going to cite ERP application names here.  Suffice it to say I’ve tried several.

As always, if this particular Document Change/Release Order template doesn’t seem to work well for your specific needs, try using Google to do a search for others.  I got 116 MS Word document  hits when I entered this search string:  “ECO, document release OR control OR request “engineering change order”  filetype:doc”.  There also editable Document Control templates/examples available formated as Excel worksheets and as Access-based data entry ‘forms’.  Just change the filetype in the search string to reflect the type of document you prefer.

As always, if you need a particular form or advice on any other quality-related matter, feel free to contact me.  I’ll be happy to do what I can to help.

Quality Resource – Product Validation Protocol Template (MS Word)

If you’re in a hurry, you can click on the image to the left to request this post’s Quality Resource, the Product Validation Protocol Template/Example in MS Word. 

I realized, as I was getting ready to transfer my work to a new computer, that I have developed, over the years, many, many types of quality assurance tools, templates and examples that I could share.  The tools I’ve developed are typically in MS Word, MS Excel, MS Access, MS PowerPoint, Adobe .pdf and a smattering of other formats. 

This will be the first such item I make available through my BLOG.  There are some standing downloads always available on the CAPAtrak website, as well.

To get to the Quality Resources I’ll be sharing with my BLOG readers, I ask that you please use a Special Request Form.   Pardon the advertisements, please.  The form was able to be created, free to me, via Bravenet.com and I cannot currently justify the expense of subscribing to the form without them making their money via ads.

The good news is, if you use the form just once, you can save the final link to your favorites and just check back at that same URL when you see me mention a new resource here.  You could share the direct link with your friends, as well, but I hope you’ll afford me the courtesy of asking them to please use the form, as well. 

By using the request form, I’ll know who cared enough to use my stuff… and I can keep those who do alerted to other new stuff from time to time.  Just so you know, I’m not exactly sure how to do that, yet.  I’m not going to load your inbox up with solicitations, that’s for sure. 

Anyway, let’s talk about this particular resource.  As I began working in FDA-regulated companies, I realized that there was a need to structure the means by which new or changed products were ‘validated’.  Just so we’re clear, ‘validation’ means checking to be sure what you’ve got is appropriate for an intended use.  Validation is typically structured against the Product Specification, which will be used to drive labelling and product performance claims.  There are many ways to approach validation and each is uniquely tailored to a specific need… but I thought you might like to see a somewhat standard and simple format for a product validation protocol that has worked for me.  Feel free to use it as a template for your own validation efforts.

If this particular validation approach doesn’t seem to resonate well with your specific needs, try searching Google for others.  I got 474 MS Word document  hits when I entered this search string:  “validation protocol” filetype:doc .

As always, if you need a particular form or advice on any other quality-related matter, feel free to contact me.