Thursday, May 31, 2012

Implementing an Effective CAPA System


Topics

Elements of an effective CAPA process
Data analysis
Getting to probable cause
CAPA timeliness
Effectiveness checks
Learning from experience

Get it in pdf, clicking here >>>

5 Signs That Your Quality System Is Dysfunctional – Take The Quiz!

by Sandra Gauvin

Have you ever noticed that when you start a new job, it’s so obvious what processes need improvement? But then overtime you begin to adapt to the culture and you tolerate the inefficient and dysfunctional practices….sometimes just to avoid conflict. Then over time, you don’t even notice the problems as much….

Take the Quiz below to see if your Quality System is dysfunctional. If you answer ‘yes’ to any of the questions, then the good news is, you’ve just been presented with an improvement opportunity.

1. Does your Standard Operating Procedures exceed 5 pages? Whenever you have procedures that ramble on and on, you really have to question the value to the people using them. Take a look at your procedures and identify the critical information that needs to be in them, then strip way all of the excess information. A great way to format your procedures is by using a system known as Information Mapping , which will typically reduce the size of your procedures and make them easier to read.

2. Do you require more than 3 signatures for all document approvals? If every document requires more than 3 signatures, regardless of the risk associated with the document, then you’re adding too many approval gates that will increase the approval cycle time and will bog down your process and frustrate your people. Most documents should only require an Owner signature, Quality signature, and a Manufacturing Signature, with the exception of higher risk documents requiring additional signatures.

3. Do you have people dedicated to just nonconformance investigations and Quality staff dedictated to their approvals? If you’ve answered ‘yes’ to this question, then you have the greatest opportunity for improvement that can impact the bottom line of your company. If you have so many nonconformance’s that it requires a dedicated staff to work on the investigations and approve the reports, then you’re not getting to the real root cause. If you don’t have a formalized trending program, then now is the time to start so that you can quickly identify issues and conclude if you’ve truly gotten to the root cause by reducing the number of nonconformance investigations (assuming you haven’t added any new products to your pipeline).

4. Do you attend so many meetings that you don’t have time to do your job? Take the time to document all of the meetings that you attend, along with their purpose, frequency, time, attendees, etc. and see if there are any redundancies….if yes, then propose to management that certain meetings be consolidated and show evidence that the same information is being covered in other meetings.

Also, really take a look at the purpose of the meetings because they may indicate that there are systemic problems that can be resolved if you get to the root cause. For example, If you’re meeting daily to determine if an observation is truly a nonconformance, then you need to look at how well your procedure is written, if nonconformance’s are clearly defined, and evaluate the overall training a person receives. You may find out that if you put a qualification program in place that it eliminates the need for the daily meetings.

5. Do you track more than 30 metrics each month? You know the saying ‘the more the merrier’?, well when it comes to metrics, more is not necessarily better. Your metrics should measure important aspects of your business that indicate how well you’re performing and when actions need to be taken. I’ve written a 23 page special report ’Boost Your Quality AND Operational Performance By Following These 3 Simple Rules‘ that’s includes valuable information about performance metrics that you really must read….you’ll also receive a monthly subscription to the Current Quality Newsletter.

Wednesday, May 30, 2012

Manufacturers are increasingly working with new, game-changing ingredients

Forging ahead
Apr 21st 2012 by The Economist



IT IS SMALL enough to be held in your hand and looks like an unremarkable chunk of metal perforated with tiny holes, but it is fiendishly hard to make. That is because it must spin 12,000 times a minute under high pressure at a temperature of 1,600°C, 200°C above the melting point of the material it is made from. And it must survive that twisting inferno long enough to propel an airliner for 24m km (15m miles) before being replaced. In all, 66 of these stubby blades are used in the rear turbine of a Rolls-Royce Trent 1000 engine, and the British company makes hundreds of thousands of these blades a year.

American and European firms have sought salvation in high-end manufacturing from the onslaught of low-cost producers. That increasingly involves becoming more inventive with materials. This article will look at a number of such innovations, including the special casting system for the Rolls-Royce turbine blades as well as the use of carbon fibre, recycled plastic waste, new battery technology and others.

Tuesday, May 29, 2012

Process Analysis

An operation is composed of processes designed to add value by transforming inputs into useful outputs. Inputs may be materials, labor, energy, and capital equipment. Outputs may be a physical product (possibly used as an input to another process) or a service. Processes can have a significant impact on the performance of a business, and process improvement can improve a firm's competitiveness.
The first step to improving a process is to analyze it in order to understand the activities, their relationships, and the values of relevant metrics. Process analysis generally involves the following tasks:

Thursday, May 24, 2012

Leaders must stop using meaningless buzzwords & focus on authenticity - How We Can Make Leadership Real Again

Change This Leadership Manifestoby Mike, Founder and Managing Director of thoughtLEADERS, LLC.

I’ve written my manifesto (no, I’m not wearing sunglasses and a hooded sweatshirt so call off the FBI and ATF). It’s a leadership manifesto. Why can’t we just make leadership real again?
We’re full of crap.  I’m tired of it.  I know you are too judging by the comments I get on the blog and the emails I receive.  I’d like us all to fix this.  To that end, I’ve written a ChangeThis manifesto.  Here’s the beginning of the document.  You can read and download the entire thing as a PDF too.

Are Habits More Powerful Than Decisions? Marketers Hope So.

By Leslie Brokaw – 5/16/12



The science of how we develop habits is used by companies both to mold consumer preference and to shape corporate culture.

Habits are powerful forces, and companies are using those forces when interacting with customers and employees.

“Over the past two decades, the science of habit formation has become a major field of research in neurology and psychology departments at hundreds of major medical centers and universities, as well as inside extremely well financed corporate labs,” wrote Charles Duhigg, a New York Times staff writer, in “How Companies Learn Your Secrets” in February.

Duhigg is everywhere these days, talking about his new best-seller “The Power of Habit: Why We Do What We Do in Life and Business (Random House, 2012). It’s a fascinating topic: habits, rather than conscious decision-making, can shape as many as 45 percent of the choices we make every day, according to a study [pdf] from Duke University.

Five of the themes Duhigg explores:

.... read them, clicking here

How Do We Change from Individuals in Workgroups to Effective, Self-Organizing Agile Teams?

Posted on May 18, 2012 by Matt Badgley

A colleague of mine at VersionOne, Dan Naden who works to support the agile community, delivered several open questions from a recent Agilepalooza and asked for help answering. The one that jumped out at me and my experiences was, “How do we change from individuals in workgroups to effective, self-organizing agile teams?”


When I first started looking at this question, I was keying in on the word “individuals” and how individual team members impact our ability to come together and self-organize. The more ideas I got down on paper, the more I came to the conclusion that it is generally not the individual team members who prevent teams from self-organizing and becoming effective. It is usually everything but the individuals that prevent teams from self-organizing. Based on my experience where I’ve lived through an inability to self-organize to efficient self-organization — the individuals are usually never the primary blockers. The things that I’ve seen prevent teams from becoming effective and self-organized are:
Agile Teams Are Too Large. Teams that are too big will not self-organize; the team members are made insignificant because their contributions may or may not impact the overall product delivery… not to mention that when teams are too large you will usually see the Alpha team members overpower and control the non-Alpha team members. This is why the recommended team size is in the single digits (I’ve seen the range of 5-8) thrown out there. Not only does right-sizing the team make planning more efficient, but it also reduces the discussion circle, thus making it easier to share information and shorten the time to make and react to decisions that impact the team and the projects.
Workspace Challenges. Studies have shown that the right workspace leads to highly productive teams. In talking with many agile teams, it’s obvious that the wrong workspace fosters silos, as well as the perception of meetings purgatory. Ideally teams are co-located and share a workspace that is conducive to easy chair-spinning conversation. A workspace with plenty of whiteboards, private zones, and an information radiator will ensure a well informed, collaborative team. When this cannot be achieved, the use of rapid and personal communication tools can help teams. IRC chat, video chat and online collaboration tools are good ways for team members to collaborate.
No Vision. There are multiple layers of vision: company, product, project and team. Obviously a team can control their vision; however, it’s usually a product of the upstream visions. So if the leadership and stakeholders are not sharing the vision – and more specifically, if the team does not have a shared vision of what they are working toward – then there is nothing to bring the team together to achieve. A clearly communicated and shared provision gives a group of individuals a common goal to achieve; this improves focus on decision-making and a clear definition of what it means to be done.
The 3 Cs. And I’m not talking about Ron Jeffries’ Card, Conversation and Confirmation. I’m referring to a Command-and-Control Culture. It seems that even once a leadership team decides to adopt agile and they genuinely buy into agile values and principles, the individuals on the teams are still reluctant to take ownership for how to win (a.k.a. achieve). It’s not until the the team is forced to make decisions do they actually make decisions. Team members who have worked in a culture that’s historically command-and-control tend to have either a victim mentality in that they simply don’t believe change is happening, or they are simply scared to put their necks out there in fear of reprisal, even when there has never been a history of this kind of action. The only way that I’ve experienced changing this culture is to have the leadership share the vision and then leave the room (a.k.a. get out of the way). When the team has success, leadership shouts it from the rooftops. And when failure occurs, leadership should ensure that learning and accountability ensues — however, doing so from a distance.
Lack of Shared Trust. A core challenge that organizations (the whole organization) have is the inability to trust others to make decisions. This usually stems from two factors: (1) a command-and-control culture that is a result of traditional project/product failures, and/or (2) management team members who have been key to the organization over a period of years and have lived the battles — thus, they feel that because of their experiences they must be a part of the decision. Remember that trust can go both ways; if the teams don’t have that shared vision, then trust of those making decisions is surely lacking.

So how do we change from individuals in workgroups to effective, self-organizing agile teams? We give our teams the environment they need to be productive, provide a clear and shared vision, have leadership get out of the way (yet be there when needed) and finally, we celebrate our small wins and ensure that we learn from our failures. I’ll assume that this stuff sounds familiar; however, if it doesn’t, give the Agile Manifesto a read: www.agilemanifesto.org. I’m sure there are more organizational behaviors, and I’m certain that individuals impact our ability to self-organize. But I firmly believe that everyone has the ability to work as a self-organized team, and if they are empowered to do so, they will do it effectively.

Please let me know what you think. What are some organizational challenges you’ve experienced which have prevented teams of individuals from becoming effective, self-organizing teams? Or do you think the organization has nothing to do with it; it’s the individual team members?

Quality Improvement in Government?

by Tim McMahon at Lean Journey Blogger

In Paul Borawski’s ASQ post this month he raises the question about quality improvement in the public sector:

So, the big question of course is–why? Why do citizens expect and demand so little accountability for the poor use of resources in government? Why do so few leaders charged with leading countries, states, provinces, and cities require improved performance?



[Read More....]

Avoid TQM Vocabulary If You Must


Total quality management (TQM) is a name some of us “quality geeks” still use. In some companies, if you mention TQM to manufacturing personnel they are likely to say, “We tried that and it didn’t work”.
TQM focuses on improving the complete performance of the work place (front office and manufacturing floor). It includes all functions, activities and those who are responsible for competitiveness of the company. Employee participation is essential not only in maintaining quality but in improving his/her total performance so that waste will be avoided, production costs lowered and the business can attain more profit.

A third industrial revolution

As manufacturing goes digital, it will change out of all recognition, says Paul Markillie. And some of the business of making things will return to rich countries
 
 

Monday, May 21, 2012

Optimization vs. Operational Reality

by Eric Michrowski
@Process Excellence & Transformation Leadership
Guide to driving transformational change through Lean Six Sigma & Process Excellence.


Over the years, service organizations have built elaborate optimization models to drive improved operational performance, particularly when it comes to scheduling team members or assets. Conceptually this makes a lot of sense and has driven significant savings and business opportunities. Nevertheless, I’ve seen too many cases where these models don’t adequately factor operational realities and business variability, often leaving missed opportunities on the table.

Thursday, May 17, 2012

Maintaining a high-performance process management team

BACK TO BASICS
Team Advantage
by Victor Cascella

Process management teams provide a framework through which complex, cross-functional processes can be assessed and optimized.

Typical team members include—
A process owner, accountable for overall performance and with direct control over the majority of resources involved.
Sub-process owners, representing major supporting functions.
Representatives from business areas with vested interest in the process, such as compliance, finance or IT.

In addition, lean Six Sigma-trained process engineers are beneficial when improvement and measurement are key team objectives.

By focusing on the following seven activities, process management teams can provide the value they are often uniquely positioned to deliver.

1. Process mapping. Process management teams use a variety of process mapping tools designed to match the intent of the mapping activity. These may include top-down illustrations, detailed flowcharts, value stream maps and swim-lane flowcharts.

Process maps also help teams identify interactions with key IT systems and supporting processes, such as financial reporting and training. Accurate process maps at the right level of detail not only deliver visibility into how work gets done, but also will serve as a basis for measurement, evaluation, accountability and continuous improvement.

2. Process performance measurement and goal setting. With the right data, process management teams can quantify performance levels, and establish meaningful targets and improvement objectives. In turn, process management teams can work to determine the factors that influence process performance, and identify functional areas and sub-processes with the greatest impact on outcomes. A subset of these measures may serve as a process dashboard or scorecard reviewed by team members on a regular basis.

3. Process analysis. Thorough, fact-based assessments of a process enable teams to identify the root causes of complex—and perhaps less obvious—process problems and failure modes. When the link to strategy is clear, and when armed with the right information, process management teams can become the premier authority for making informed, intelligent decisions regarding where and how improvement resources are best applied for maximum impact on performance.

4. Process risk assessment. Process management teams must understand and quantify the risks to achieving process goals and objectives. In addition to accounting for operational risks, process management teams must stay alert to other critical risk dimensions, such as financial and compliance risk. Analytical tools such as failure modes and effects analysis can help evaluate risk.

5. Project selection and management. A key responsibility of process management teams is to sponsor, launch and manage improvement projects. Exceptional process management teams are likely running and managing a portfolio of concurrent—and often integrated—improvement efforts focused on a few critical business outcomes.

6. Getting changes to stick. Changing processes almost always requires changes to people’s behaviors—sometimes drastic changes from the past. This becomes a challenge when attempting to get changes and improvements to stick, requiring process management teams to be particularly concerned about improvement sustainability. Success requires following through on new procedures and behaviors to ensure they are fully understood and adopted by the members expected to carry them out.

7. Leveraging best practices. Process management teams may achieve gains in process areas that are very similar, or sometimes even identical, to those that reside in other geographical or organizational elements of the same business. By working with other business units throughout their organizations, the teams can identify and capitalize on better ways of working and leverage their local best practices more broadly.
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Victor Cascella is the director of business process management at MedImmune in Gaithersburg, MD. He earned an MBA from California Lutheran University in Thousand Oaks, CA. He is a member of ASQ.

It's Time to Rethink Continuous Improvement

by Ron Ashkenas - managing partner of Schaffer Consulting and a co-author of The GE Work-Out and The Boundaryless Organization. His latest book is Simply Effective.

Six Sigma, Kaizen, Lean, and other variations on continuous improvement can be hazardous to your organization's health. While it may be heresy to say this, recent evidence from Japan and elsewhere suggests that it's time to question these methods.
 

ASQ InfVoices - The Government Quality Puzzle in Hong Kong

May topic of ASQ Influential Voice is come from ASQ CEO Paul Borawski's question "why government is reluctant to embrace quality?" I would like to introduce the government role on quality movement in Hong Kong. (Lotto Lai, et al., 2007). After that the Efficiency Unit (EU) and Performance Pledges system in HKSAR government will be also briefed.
(One part of my presentation was Hong Kong Quality Movement which presented in TQM Uz 2012 Forum in Tashkent, Uzbekistan on 26 April 2012)

Monday, May 14, 2012

9 Qualities of Remarkable Entrepreneurs

OWNERS' MANUAL | Jeff Haden
May 14, 2012

What separates the best from everyone else? (Hint: It's not about the money.)
Good entrepreneurs make money.
Great entrepreneurs make serious money.

But remarkable entrepreneurs do more than make money. They are the few who possess qualities that don't appear on balance sheets but do make a significant impact on the lives of their employees, industries, and communities.

Here are nine qualities of remarkable entrepreneurs:

.....[ckick here]

Sunday, May 13, 2012

Designing Survey with Google Docs

Now you are able to use Google Docs and design and manage your own surveys for free. Google Docs allows you to create a survey and email your survey to your customers or employees. Survey responses are automatically saved in your Google Docs account. This is very easy to use tool which allows you to create forms and surveys for your small business. All you need to do is to use your Google account and login to your Google Docs and you are ready to start designing your survey. It is free and easy to do it so you can create your surveys in a few minutes.

[continuing...]

The Changing Game of Strategy

by Greg

In Oliver Stone’s classic movie Wall Street, the financier Gordon Gecko schooled his protégé in the aphorisms of Sun Tzu, the ancient Chinese military philosopher.

The point was clear. Business is war, an ancient game with eternal truths and the essence of strategy is a methodical, time-tested approach. Superior planning, matched with flawless execution, is the key to domination of the competitive environment.

It sounds good, but we’ve long known that strategic planning has serious limitations The notion of managers as generals, guiding action from high on the hill, is an outdated concept at best. While that doesn’t always register with us grownups, the often-maligned Millennials know it intuitively and a lot of that has to do with the games they play.

[more....]

Thursday, May 10, 2012

A Guide to Key Articles

A Guide to Key Articles

Baldrige.com now has 500 articles available that provide “the information you need to build the organization you want.” That includes your guide to building the career you want, The Baldrige Edge, available here.

Monday, May 7, 2012

Can a Company Be Too Big to Serve?

by Susan Mazza on April 25, 2012
....

As I [Susan] reflect on my experience here are my initial thoughts on whether a company can become too big to serve.


I don’t think it is an issue of size, but rather an issue of mechanizing human interaction to the point where…

…scripts replace effective 2 way communication;

…intelligence is stamped out by procedures; and

…personal responsibility becomes irrelevant because there’s always someone you not only can, but are expected to pass the problem along to with no expectation of following up.

Your system is broken when…

…the only person who owns the customer’s problem is the customer

…the customer is forced to learn your language and processes just to survive their interactions and finds they often knows them better than your employees.

If you , Comcast and AT&T, or any big company is going to step up your customer service, it’s time to stop trying to fix a human system with a machine based model in the never ending quest for maximizing efficiency. It is not working. The alternative is start reinventing your organizations to help employees and customers alike deal effectively with the inherent complexity and inevitable breakdowns.

You have some great people working for you Comcast and AT&T and they appear to be drowning in a sea of mediocrity perpetuated by flaws in your support systems. Please help those people so they can help us.
 

5 Things to be Learned About Project Management avoiding Hard Way

Project work is what I love doing but I realize that it isn’t a perfect world. Some of the most valuable lessons I have picked up have come the hard way, so I thought it would be a good idea to share with them with other people who might not have come across them yet.
Read more....

Wednesday, May 2, 2012

The Importance of Having a Project Charter

03:11 AM May 1, 2012     
The Project Management Body of Knowledge (PMBOK) defines a project charter as a document that formally authorizes a project. The project charter is not created by the Project Manager. Instead, it is issued by the sponsor to empower the Project Manager with the authority to begin the project and obtain resources for project activities. The [...]
Original Author : Patti Gilchrist
Courtesy : http://www.freepmstudy.com

Operate Your Organization Well using In-depth Project Integration Management

03:16 AM May 1, 2012  
Project Management is the method of coordinating the factors of a project, whether the project is advancement of a new item, an advertising campaign or launching of a new service. A project is a organized task that produces a particular final result. Project integration management is a component of project management that harmonizes every aspect [...]
Original Author : Feona Lewis
Courtesy : http://mrlehieu-zzoo.blogspot.in/

What Is Prince2?

02:52 AM May 2, 2012     
What is Prince2? It represents Projects in a Controlled Environment and is adopted in 150 countries and by more than 20,000 establishments. Numbers of individuals taking the exams have expanded by approximately 20 % per year. It can be used to manage a project of any form or size, that is, it is universal. The [...]
Original Author : Arnold Monk

HOW NOT TO ACHIEVE LOW COST

Why it is so hard to reduce cost or "implement" DFM after design


First, let’s look at cost reduction as Dysfunctional Engineering Incorporated:



    So let’s look at what is wrong with this very common picture. The first shortcoming of this approach is leaving cost reduction until after the product is designed and already in production. In their haste to rush early production units to market, many companies defer cost concerns until later with “cost reduction” efforts. The first problem with this strategy is that it probably will not happen because of competing priorities, and thus, costs remain high for the life of the product. The second problem is that cost reduction simply cannot be very effective at all!

Are You Past-Oriented or Future-Oriented?

How do you spend your time?  And do you reminisce about the past, or plan for the future?
Our children have a unique perspective and way of thinking that has been immensely influenced by technology.  Consider thinking patterns of yourself and others with the following animation video:

Are you Past-Oriented or Future-Oriented?

The Thought-Patterns of Success

by Elizabeth Grace Saunders

Your passion for your career can sabotage your attempts to succeed.
When you go from feeling energized, excited and in control of your work to feeling an overwhelming compulsion to achieve and produce, you've tipped from helpful harmonious passion into harmful obsessive passion.
But when you've grown accustomed to operating from a state of obsessive passion, you may want to act differently, but you just don't know how. Your deeply ingrained mental and behavioral patterns naturally lead you toward seemingly uncontrollable compulsion to work. Paradoxically, these natural reflexes inhibit the quality of your professional output. And when you do make small attempts to change, like leaving the office on time, you experience withdrawal symptoms, which send you scurrying back to your familiar habit patterns.
Fortunately, there is hope.  [continuing....]

How to Retain your Top Employees

Keeping your employees - especially your top performers is critical for your business success. Smart companies develop Employee Retention Plan to improve their current Employee Retention Rate and develop high performance organizations. Companies can improve their Employee Retention Rate in many ways but it is critical for them to understand that they need to have Employee Retention Plan in place and take this as an ongoing project – one of the key projects for long-term business success.

The Quest for Knowledge

by Dr. Harry Hertz, Director
Baldrige Performance Excellence Program

At the annual Quest for Excellence® conference, I am always amazed at how openly the Baldrige Award winners share their experiences and best practices. Every year I take away a few key messages that provide me with insights into excellent organizations. This year I heard seven themes in the presentations that represent commonalities among the 2011 award winners. I marvel at such commonalities because of the diversity of organizations in each year’s group of winners. The 2011 Baldrige Award winners are a community hospital with under 100 beds (Schneck Medical Center), a major health system with multiple hospitals and many additional service offerings (Henry Ford Health System), a customer-owned health cooperative serving many customers and a large geographic area, with some parts accessible only by plane (Southcentral Foundation), and a 143-year-old publisher of religious materials (Concordia Publishing House).


Here are the seven key themes:
[click here to access it ....]