Tools Blog

Core Tools Support (CTS) Software Released

March 26th, 2019

AIAG announced the release of their core tools support software, a cloud-based solution for authoring and managing core tool documentation such as FMEAs, Control Plans and PPAP documents. The software also allows for collaboration across multiple sites.

Features:

  • Linkages between forms such as Control Plan & FMEA

  • Flexibility in creating task templates

  • Reporting across parts and projects

  • Main menu showing tasks, priorities, meetings, calendar & more

  • Search bar for quick content look-up

  • Instant updates of latest forms & templates

  • Tracking & uploading of PPAP documentation (i.e. GR&R studies, design records)

  • Project planning tools for APQP (i.e. meeting minutes, action tracking, etc.)

Pricing:

Member: $360 annually per concurrent user

Non-Member: $360 annually per concurrent user

Additional Storage: $120 annually per 50GB

Language: English

The Ultimate Problem Solving Roadmap

Roadmap for selecting the right problem solving tool

A rational for problem solving by Sidney Porto & Jim Thompson

When the only thing you have is a hammer… everything looks like a nail. But a hammer isn’t always the tool you need to get the job done right. A problem that we see far too often is the use of the wrong tool, or the SAME tool, for each problem or opportunity to improve a product or process.

With enough experience, solving problems can be intuitive. But only through a commonly understood problem solving methodology is it possible to implement effective solutions for a problem or opportunity at hand. Although we all make small corrections every single day, effective implementation of corrective action through in-depth problem solving take correction to a different level – time, money and discipline included. So how do you know which tool to use for each unique problem or opportunity?

Step 1 – Clearly identify the problem

While PDCA (Plan, Do, Check, Act) is common in the world of management systems and problem solving, Robert Kettering said it best: “A problem well stated is a problem half solved.” Instead of using the PDCA Cycle, we frequently use the acronym IDPDCA. ID = Identify. You can have the best root cause analysis and problem solving techniques in the world, but if you’re solving the wrong problem (i.e. low impact or low return), then your efforts may not be worthwhile. Use the worksheet in Figure 1 - 5W2H Problem Definition Worksheet to capture the who, what, when, where, why, how and how many of the issue observed.

Figure 1 - 5W2H Problem Definition Worksheet

Figure 1 - 5W2H Problem Definition Worksheet

Step 2 – Prioritization based on impact

Figure 2 - Impact Funnel

Figure 2 - Impact Funnel

Problems, risks and opportunities come in various forms of impact and complexity. The impact of an issue can span from a loss of life or limb through something that simply needs to be done to make the lunch room smell better.  Tools ranging from a SWOT Analysis (Strengths, Weaknesses, Opportunities and Threats) to a C&E Matrix (Cause & Effect) or the FMEA (Failure Modes & Effects Analysis) can assist in giving a value to an issue. The bottom line is this – you can’t do everything at the same time. This of this step as a funnel. You can put every issue in the world into the funnel, but you only have the resources to focus on a few at a time. See Figure 2 – Impact Funnel.

We recommend ranking issues from, say, 1 to 10, using 2 to 3 variables such as cost, impact to the customer and ease of implementation. In some cases, such as QMS requirements in the automotive sector (i.e. IATF 16949:2016), prescribed variables such as severity, occurrence frequency and detection risk are all multiplied together for what is called a risk priority number (RPN) to promote focus on the highest risk characteristics.

Step 3 - Selecting the correct primary tool

Figure 3 – List of primary tools based on severity

Figure 3 – List of primary tools based on severity

Figure 3 – List of primary tools based on severity illustrates the relationship between the issue type, issue impact or significance, and the recommended problem solving tool. Simple tools should be used for minor problems that are easy to solve, and where the cause and/or solution may be apparent. Comprehensive tools should be used for complex issues to get to the bottom of what is causing, or may cause, the issue at hand. And comprehensive set of tools should be used for chronic issues such as the methodology found in Six Sigma. Most issues will fall into the category of “solutions unknown” or “complex” and therefore should be solved using the A3, FTA (Fault Tree Analysis), 8D (disciplines) or a variation of two or more of these primary tools.

Step 4 - Selecting the correct secondary tool

In our fourth step, we structure the problem-solving resolution into 3 distinct lanes:

  1. Problem definition
  2. Root cause(s) identification
  3. Corrective action implementation

This sounds simple because it is simple. All fundamental requirements such as containment, validation of alternatives and effectiveness checks will fit into one of these three lanes on the roadmap. See Figure 4 – Roadmap for Problem Solving.

Figure 4 – Roadmap for Problem Solving.

Figure 4 – Roadmap for Problem Solving.

During the root cause analysis phase, ensure that any data being gathered and analyzed is accurate by conducting a measurement system analysis (MSA). Outputs and effective solutions are only as good as the integrity of the inputs and reasonable bias or measurement error (ideally < 10%).

Like Step 3, the effectiveness of your problem-solving results is highly dependable of the set of secondary problem solving tools you have selected. Figure 4 also suggests which secondary tool(s) to use as well as the sequence of usage for optimal results.

Conclusion

Do you feel this roadmap can guide you on most of the formal problem common solving resolution? Want to learn any specific tool described here. Concentric Global counts on a team of subject matter experts in the USA and South America that can help you on this arena.

Download white paper (PDF)

Purchase Problem Solving Tools & Templates

Correlation Matrices

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

Correlation Matrices

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

ISO 9001 Correlation_Matrices from TC176SC02

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

ISO 9001 & Six Sigma Infographic

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

Visual communication through ISO 9001 & Six Sigma Infographic

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

ISO 9001 & Six Sigma Infographic

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

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

PRESS RELEASE: Concentric Congratulates Jim Thompson and the Compliance+ Team

FOR IMMEDIATE RELEASE: Contact:
Ronii Bartles Concentric ronii.bartles@cmsicharleston.com www.acommoncenter.com

Concentric Congratulates Jim Thompson and the Compliance+ Team Compliance+ selected as part of CoHort 3 the Harbor Accelerator Program

Charleston, SC, January 29, 2015 — Concentric announced today that one of its affiliate start-up companies, Compliance+, has been selected by the Harbor Entrepreneur Center as one of eight companies for its CoHort 3 business accelerator program. Jim Thompson, the owner of both Concentric and Compliance+ was quoted by saying “I’m so pumped for this incredible opportunity”. CoHort 3 has officially already begun and Compliance+ is already hard at work.

As to why Jim and Concentric are excited about this opportunity for Compliance+, Jim says “Concentric was interested in developing a scalable digital product that would improve our consulting and training services. The majority of our team members are certified auditors, so it just made sense to create a mobile auditing checklist. With the wave of changes to ISO 9001 later this year, we know that this standard is where we want to be. With over 1.2 million companies certified to this quality standard globally, Compliance+ is a perfect fit for our initial focus.”

For additional information or to schedule an interview with Jim Thompson, please contact Ronii Bartles at (843) 452-5259 or e-mail Ronii at ronii.bartles@cmsicharleston.com.

Concentric is a Quality Resource HUB based out of Charleston, SC. We have partnered with companies to provide you with a holistic solution for your Quality Management Systems. Though products, trainings and implementation resources, Concentric helps organizations perform better through requirements management, process design, management system implementation, lean operations, problem solving and ISO certifications (i.e. ISO 9001, ISO 14001, OHSAS 18001, ISO/TS 16949, AS9100 series, ISO 27001, ISO 50001 & others). We are built up of subject-matter experts (SMEs) in Six Sigma, Lean, ISO standards, business law, operations, leadership and strategic planning. We work for you. You will increase your competitiveness and profitability when working with our SMEs because we provide consultation and training services that result in reduced waste and risk, increased customer satisfaction and increased profitability.

Compliance+ is a cloud­based mobile application used to improve process performance, meet requirements of industry standards and improve bottom line.

# # #

Standard Blitz

Want a quick exercise for initial auditor training or a refresher for your veteran audit team members? This quick and simple "ISO scavenger hunt" will help your auditors quickly locate key requirements. Exercise:  In a small group, locate each of the following requirements or keywords in ISO 9001 & ISO/TS 16949.  Record the number of times the keyword is mentioned, the clause numbers and the title/description on easel pads. It is also recommended that you record all of these findings using the table of contents in the front of your standard.

Standard Blitz Table

 

 

 

 

EXERCISE ANSWER KEY

DOCUMENTED PROCEDURES (7)
*4.2.1/4.2.2 (mentions requirements)
Control of Documents (4.2.3)
Control of Records (4.2.4)
Training (6.2.2.2)
Internal Audits (8.2.2)
Control of Nonconformities (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
 
RECORDS (26)
*Several mentions of record in general prior to 4.2.3)
4.2.3.1 - Engineering specification changes
5.6.1 - Management review records
6.2.2 (e) - Education, training, skills & experience
7.1 (d) - Product & realization processes evidence (plan vs. actual)
7.2.2 - Product requirements review (feasibility)
7.3.2 - Design & development input
7.3.4 - Design & development review
7.3.5 - Design & development verification
7.3.6 - Design & development validation
7.3.7 - Design & development changes
7.4.1 - Supplier evaluations & actions
7.5.2 - Validation records
7.5.3 - Product identification & traceability
7.5.4 - Lost, damaged or unusable customer property
7.6a - Basis for calibration (in case of no standard method)
7.6 (under e) - Calibration & verification records
7.6.2 - Calibration & verification records
8.2.2 - Internal audit records
8.2.3.1 - Significant process events
8.2.3.1 - Records of effective dates of process changes
8.2.4 - Product conformity & person(s) releasing records
8.3 - Nonconforming material (nature, actions, concessions)
8.3.4 - Expiration date or quantity authorized under concession
8.5.2 - Results of corrective actions
8.5.2.4 - Records of rejected product test/analyses
8.5.3 - Results of preventive actions
 
EFFECTIVE(NESS)(LY) (ISO = 26 & TS = 36)
0.2 – Introduction - Process approach (twice)
0.2c – Introduction - Process approach
0.3 – Introduction - Relationship with ISO 9004
1.1b - Scope - General
4.1 – General requirements
4.1c – General requirements
4.2.1d - Documentation requirements – general
4.2.4 – Control of records
5.1 – Management commitment
5.1.1 – Process efficiency
5.3b – Quality policy
5.5.3 – Internal communication
5.6.1 – Management review – General
5.6.3a – Management review – Review output
6.1a – Provision of resources
6.2.2c – Competence, awareness & training
6.3.1 – Plant, facility & equipment planning (& Note)
7.2.3 – Customer communication
7.3.1 – Design & development planning
7.4.1 – Purchasing Process (Note 2)
7.5.1.4 – Preventive & predictive maintenance (twice)
7.5.1.8 – Service agreement with customer
8.1c – Measurement, analysis & improvement – general
8.2.2b – Internal audit
8.2.2.2 – Manufacturing process audit
8.2.3 – Monitoring & measurement of processes (Note)
8.2.3.1 - Monitoring & measurement of manufacturing processes
8.4 – Analysis of data (twice)
8.5.1 – Continual improvement
8.5.2f – Corrective action
8.5.2.4 – Rejected product test/analysis (Note)
8.5.3e – Preventive action
 
EFFICIENT(CY) (3) – None in ISO 9001, but 3 in ISO/TS 16949
 5.1.1 - Process efficiency
 7.5.1.4 - Preventive and predictive maintenance
 8.2.1.1 - Customer satisfaction — Supplemental
 
CUSTOMER SATISFACTION (9)
0.2 - Introduction - Process approach (twice)
1.1b - Scope – General
5.2 - Customer focus
5.6.1.1 - QMS performance
6.1b - Provision of resources
8.2.1 - Monitoring & Measurement – Customer satisfaction
8.2.1.1 - Customer Satisfaction - Supplement
8.4a - Analysis of data
 
BUSINESS PLAN (2)
5.4.1.1 - Quality objectives - Supplemental
5.6.1.1 - Quality management system performance
 
MANAGING COSTS & RISKS (0)
None in 9001 however… ISO 9004, Introduction – General (0.1)
 
COST (5)
3.1.9 - Premium freight
5.6.1.1 - Quality management system performance
7.3.2.1 - Product design input
7.3.4.1 - Manufacturing process design input
7.3.4.1 - Monitoring (Note)
 
RISK (7)
0.1a - Introduction - General
0.4 - Compatibility with other management systems
6.4.1 - Personnel safety to achieve conformity to product requirements
7.2.2.2 - Organization manufacturing feasibility
7.3.1.1 - Multidisciplinary approach
7.3.2.2 - Manufacturing process design input
7.3.4.1 - Design & development review - Monitoring
 

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

White Paper: Strategic Planning

Download our latest White Paper Keys to Competitiveness using Strategy. In this paper you will learn the tools to begin to developing an organization strategy plan and use it as a foundation for setting your organization up for success. Here is an excerpt:

How important do you feel planning is to remain competitive? Do companies routinely take time to plan? Typically…no. (Ain’t nobody got time for that!) It is far more exciting to be reactive – to be the hero that solves the problem at the time of crisis. Whatever adrenaline rush you get from this, it is a poor way to run a business. Many of your competitors ARE planning. This puts you at a distinct disadvantage. However there are some companies are not planning. So applying this discipline gives you the competitive advantage over others.

It all starts with strong leadership.

Great leaders inspire others to greatness. They get more energy and creativity from their staff than complacent managers. They help create vision, urgency, discipline, and accountability – many keys to successful strategic planning. Leadership is needed for strategic plan development, strategic plan implementation, and strategic plan systematization.

You need to ask yourself this one question… Are you a strong leader that is ready for the strategic planning processes? 

To read the entire White Paper: Keys to Competitiveness Using Strategy you can download it here.

Improving Your Corrective Action Process

If I had to pick one area to focus on within all of the hundreds of management systems I’ve audited over the past 19 years, I would definitely choose the corrective action process. From my experience, and the war stories I hear from other auditors and quality professionals, most organizations just don’t get it. What makes this circumstance even worse is when management insists on “More audits! More Audits! MORE AUDITS!!!” while doing little to nothing about the previous audit findings, repeat customer complaints or piles of supplier issues. That would be similar to handing out tickets for traffic violations with no means of collecting money for fines. (Note: I’m not suggesting that auditors are Police officers.) Here are 10 questions you may want to consider to help improve your procedure for handling nonconformities (actual or potential) and corrective actions as first steps to improving your corrective action process.

1. Are the roles within your corrective action process defined? The following list of roles is a good place to start. Document these roles, ensure these roles are clear and understood, and document them in your written procedure.

[bulletlist]

  • Originator
  • Assignee
  • Sponsor or Process Owner (if different than Assignee)
  • Problem solving group team members
  • Review Board
  • Approver
  • Evaluator or Effectiveness Checker

[/bulletlist]

2. What are all of the sources of your nonconformities? List them out using the following categories as a guide (think “CIS” with a stutter):

[bulletlist]

  • Customer complaints – External Customers (includes campaigns, field returns, warranty issues, service reports, etc.)
  • Customer complaints – Internal Customers (sister plants, corporate office, etc.)
  • Internal Product Nonconformities
  • Internal Process Nonconformities (all management system processes apply, not just production)
  • Suppliers – Internal Suppliers (sister plants, corporate office, etc.)
  • Suppliers – External (goods & service)

[/bulletlist]

3. How are these various nonconformities initially captured?

[bulletlist]

  • Is there a single depository for collecting all types/sources of nonconformities (recommended)?
  • Are there multiple tracking tools for capturing the various types/sources of nonconformities (not recommended)?

[/bulletlist]

4. How are nonconformities reviewed and ranked in order to analyze severity, trends or systematic failures?

[bulletlist]

  • How severe is the occurrence of a single nonconformity (1X)?
  • How often does this nonconformity occur (1X, 15X, 23056X)?
  • If nonconformity X “snuck into your facility”, how likely would you be to detect its presence vs. passing it along to the next process or customer (1X = easy to detect and 10X = impossible to detect)?
  • Note: Some organizations use a formal ranking system for severity, occurrence and detection to provide an actual score for how risky or significant the nonconformity is or could be. Want to learn more about this approach? Read our FMEA blog.

[/bulletlist]

5. When are nonconformities escalated in order to eliminate the cause to prevent recurrence of the issue via a formal corrective action request or a project (i.e. formal CAPA, major capital project, 6S project, Problem Solving Group, Value-Stream Mapping, etc.)? How does this escalation process work? Who studies the business impact of X and decides which course of action should be taken?

[bulletlist]

  • Do you have a Nonconformity Review Board (NRB)?
  • Is the escalation automatically based on a scoring system (see item #3 above)?
  • How do you ensure there are not duplicated efforts or assignments? (18 CARs issued to the Purchasing Manager for the same issue is like telling your kid she’s grounded 18 times. One “grounding” should cover it.)

[/bulletlist]

6. What type of progress tracking mechanism is used to ensure clear assignments, appropriate deadlines, progress tracking, etc.? At a minimum, this progress-tracking tool should include:

[bulletlist]

  • Serial # (unique identifier)
  • Source of the nonconformance
  • Assignee
  • Short description of the issue
  • Expected due date
  • Date done
  • Progress indicator (i.e. % complete)
  • Additional comments field

[/bulletlist]

Ensure the tracking tool is visible and highlights those items that are on schedule, approaching a due date or past the expected due date. (Note: I like red/yellow/green indicators).

7. What types of problem solving tool(s) is/are used in order to clearly identify the root cause?

[bulletlist]

  • Does your problem solving group facilitator know how to properly use the prescribed root cause analysis tool?
  • Are there multiple root causes considered in the tool being used?
  • Can data be captured to support the root cause(s) analysis conclusion such as % of contribution (i.e. P-value, Pareto, Histogram, etc.)?

[/bulletlist]

8. How are necessary actions determined and assigned during the problem solving process?

[bulletlist]

  • How is progress reported? (Note: Generally, I would recommend a macro view and top 3 micro view weekly in a top management meeting.)
  • How are assignees of action items notified?
  • Is there a process for acknowledging the action assignments in a timely manner?

[/bulletlist]

9. How is corrective action(s) taken reviewed to ensure it has been effectively addressed?

[bulletlist]

  • Verification by the assignee or the applicable Process Owner (must be done first)
  • Verification by the Assignor, Originator or via the Internal Auditing Process (must be done second)
  • How is long-term effectiveness evaluated? Consider giving each incident an “effectiveness grade” based on the overall method and evidence. The grade level should be directly proportional to your confidence level in the failure mode never showing its ugly face again.

[/bulletlist]

10. How is the problem solving process documented and recorded for future reference?

Has the initial tracking tool described in item #2 been updated?

Are results of the “Lesson’s Learned” available and shared with other areas, sister plants, stakeholders of similar goods, services or processes within your organization?

[bulletlist]

  • Has the action to prevent future occurrence been monetized?
    • What is the cost of this instance of the failure mode X (CoPQ or cost of poor quality)?
    • What is the estimated total historical cost of X since inception?
    • What is the value of cost avoidance based on historical costs and future forecasts?
  •  Note: Validate these financial figures by getting input and approval from your CFO, Controller or other Financial Leader.
  • Keep in mind the key to record retention is record retrieval. A good tracking tool with specific codes for each failure mode (i.e. X, Y and Z, etc.) makes future analysis of data much more likely.

[/bulletlist]

Check out The Ultimate CAPA Report below to help you drive the right behavior. Stay posted to future blogs regarding corrective action tools and templates. These will be available on our products store. We also offer CAPA training.

Ultimate CAPA Report

 

The Use & Misuse of the FMEA


problemThe term “FMEA” is an abbreviation for the failure analysis tool referred to as “Failure Modes & Effects Analysis”. The purpose of this tool and methodology is to analyze failure modes and the effects of each failure mode. For example, a failure mode of loading a blank envelope into the printer would be “loading envelope upside down”. The effect would be “printing Ship To address on wrong side of envelope”. All things considered, printing a single envelope upside down is no big deal. The overall cost and time to re-print is relatively low. But what if your company is a printing company? What if you load the envelopes incorrectly and print 15,000 envelopes on the WRONG SIDE? The potential effects of this extreme scenario would likely cost you hundreds of dollars and several hours of lost production time. The effect on your customer may be a delayed shipment on critical marketing material related to an upcoming major trade show. Congratulations! By not adequately addressing this failure mode, you have added stress, cost and time to a profit margin that was already very slim. Formal use of the failure modes and effects analysis (FMEA) tool began in the 1940s, where it was first used to study failures, defects or malfunctions by reliability engineers in the US Military. The tool was used to anticipate each possible failure and the consequence of each failure as a means of mitigating risk. Since then, this risk prevention tool has been used by various industrial and government entities from NASA to the EPA, and later Ford, GM and Chrysler. Today, the FMEA is used in various functions as a means of error-proofing or designing defect detection mechanisms into machines (MFMEA), processes (PFMEA), material movement or logistics (LFMEA) and product designs (DFMEA).

FMEA - Failure Modes & Effects Analysis Template 4th Ed

Severity (1 to 10) x Occurrence (1 to 10) x Detection (1 to 10) = Total RPN (1 to 1000) How bad would it be? x What’s the likelihood? x How hard would it be to detect and contain? = RPN

The following list provides further guidance on the use and misuse of the failure modes and effects analysis tool:

Use

[bulletlist]

  • inventory of known OR potential failure modes
  • part of contract agreement used to assess & report risk
  • connects with Control Plan to illustrate mitigation or reaction to each known or potential failure mode
  • helps prioritize order of importance based on risk priority number (RPN)
  • captures "lessons learned" about failures or potential failures from similar situations, products or processes as a means of minimizing risk
  • ensures that all failures are considered from prototype to pre-production and through launch of full production
  • helps to define actions and responsibility for cross-functional teams
  • increases profitability by reducing overhead expense such as rework, repair, sorting and scrap

[/bulletlist]

Misuse

[bulletlist]

  • typically used at the time of process signoff or approval from the customer, then archived ("tossed aside") therefor failing to be properly update and communicate to team (dormant vs. evergreen)
  • not connected as an OUTPUT to CAPA process (CAR or PAR should nearly always reduce S, O and/or D); with every corrective or preventive action taken, the S, O and/or D SHOULD be lowered or the action taken was ineffective
  • opportunity lost in risk reduction by stopping at customer sign-off
  • increases waste through reliance on redundant systems (i.e. detection mechanisms no longer needed)
  • higher level management reliance on a poorly conceived or misleading FMEA rankings
  • intentionally ranking failure modes lower than true risk in order to avoid required improvement activities
  • misrepresentation of the true risk of a process that is then benchmarked for future product and process design

[/bulletlist]

Would you like to learn more about the use of the FMEA tool? Contact us here.

Do you need an FMEA Template that includes guidance on template usage as well as individual tabs for guidance on properly ranking severity, occurrence, and detection level? Visit our online products store here.

 

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.

ASQ Lowcountry Quality Conference 2013 & Management System Architect

The 12-Piece Blueprint This past week was a very successful week indeed - full of signs of spring and new opportunities. A major catalyst of our excitement to bring Concentric's story to the Charleston community was the ASQ Lowcountry Quality Conference organized by our local ASQ Section 1122 volunteers. This 2-day conference featured an amazing array of speakers and Quality Professionals who gave attendees their foresight into the future commercial needs of the region. In addition to the great line-up of speakers from various industries across the spectrum, nearly half of the participants were treated to an extended tour of the new Boeing South Carolina campus. It is rare to hear a planning committee genuinely pumped up after the conference ended saying , "Count me in for planning this thing in 2014!" This statement, above all other metrics, was the most impressive indicator of a successful conference with a bright future in 2014.

Concentric was well represented during the conference. It was jokingly stated at various points throughout the conference that "Concentric has provided 7 speakers - 2 actual guest speakers, 1 on standby as a contingency plan and 4 audio speakers. (We donated our A/V equipment.) Robert Jenkins spoke about the leap that is required for an organization to jump from ISO 9001 certification to AS9100C - the latest aerospace quality management system international standards - while I spoke about a new concept I refer to as "The Management System Architect".

The Management System Architect uses stories and real life examples to introduce change agents to simple tools for the purpose of visualizing activities that take place within an organization. Like a traditional architect, the Management System Architect must put together components that ultimately satisfy the needs and expectations of the customer. Unlike a traditional architect, the Management System Architect is challenged with managing elements of an organization that can not be seen by the naked eye. Rather than physical components such as lumber, hardware and fasteners, the Management System Architect must use simple documents such as flowcharts, maps and other visual representations of action to illustrate how activities within an organization fit together.

The Management System Architect

Throughout the next several months, I encourage you to stay tuned to the progress of my first attempt at authoring a real book. The end product will be a book and a workbook. The book will be an in-depth roadmap for management system implementers and process owners on how to use twelve tools over the course of twelve months. These tools will guide "architects" as they build the fundamental framework of organizational flow and interactions. The accompanying workbook will be a supplement of dozens of downloadable tools and templates allowing you to customize the tools to fit the functions and branding of your specific operations.

We are all extremely busy. Writing a book has been on my bucket list since my mid 20's. Although I failed to make that goal by 30, there is still time to write a book by the time I'm 40. (Dr. Leah Jackman-Wheitner reminded me that just because I missed the 30-year mark, that doesn't give me an easy way out. "There's still plenty of time to write your dang book!") Like any good engineer, having deadlines, metrics and a good plan is what will drive my behavior. By adding accountability to the formula, there is nowhere to hide. I'm asking for your participation. I'd like you to help me by being my accountability partner.

Here are the major milestones: May 17th, 2013 - Management System Architect Toolbox featuring 55+ tools & templates (eWorkbook) May 31st, 2013 - Management System Architect Toolbox (Hardcopy Workbook) June 28th, 2013 - Free Chapter available for download to our blog subscribers November 30th, 2013 - Completion of First Edition of The Management System Architect (eBook) December 21st, 2013 - The Management System Architect Bundle (Hardcopy Book & Workbook with download code for eBook & eWorkbook)

As our gift to you as a subscriber, here is a link my ASQ Conference slideshow: Http://www.acommoncenter.com/architect

Do you know someone else that may be interested in following my progress? Simply forward this blog post and ask them to subscribe here: http://eepurl.com/f0Swn

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

Process Flow Diagrams

Several customers have asked recently about an AIAG standard for process flow diagrams.  While there is no standard template within the AIAG core tools (blue manuals), there are guidelines within the APQP manual that automotive organizations should adhere to. The AIAG - APQP Manual (Second Edition), section 3.3 states, "The process flow chart is a schematic representation of the current or proposed process flow.  It can be used to analyze sources of variation of machines, materials, methods, and manpower from the beginning to end of a manufacturing or assembly process.  It is used to emphasize the impact of sources of variation on the process."  The flow chart helps to analyze the total process rather than individual steps in the process.  The flow chart assists the organization's product quality planning team to focus on the process when conducting the PFMEA and designing the Control Plan.

The Process Flow Chart Checklist below can be used by the organization's product quality planning team to verify completeness or set a standard within the organization for basic flow chart requirements.

Image

The following shapes are typically used to illustrate various process steps within a flowchart.

• Operation (circle) - Value-added manufacturing step
• Transport (arrow) - Movement of product or components from one operation step to the next
• Inspection (square) - Product or process inspection step
• Storage (triangle) - Component or part storage
• Combination: Inspection & Operation (square & circle) - Value-added manufacturing step with distinct product or process inspection steps with variable output data
• Delay - Designed delay that is part of the process

Software Tip: These shapes can be found in the Microsoft Visio "Process Flow" or Microsoft Powerpoint Insert > Shapes menus.

Microsoft also has a site full of FREE templates that can be downloaded for a variety of different flowchart uses.

Happy flow-charting!

SIPOC vs. Turtle

SIPOC Part I of II Ok... Ok... Geez people!  Who would have known that a flippin' TURTLE diagram could cause such a stir.  So far this month, I've been yelled at by a Brit, received kind comments from my Indian friends and told that my system is in shambles - ALL DUE TO THE USE OF TURTLE DIAGRAMS!  Honestly guys, I will admit that I'm a quality geek from time to time, but I don't care enough about any process improvement tool to start a fight over it.  Ok... that's a stretch.  But I can honestly say that I never knew that something called a "turtle" could cause such internet traffic and conference room debates.  I will offer this opportunity for those that find it difficult to image the benefit of something as simple as a high-level process flowchart (i.e turtle diagram).  It's called a SIPOC diagram.  If you don't like this either, then maybe the problem is YOU... that's all I'm sayin'.

SIPOC is short for Supplier, Inputs, Process, Outputs & Customer.  SIPOC  is one of many process mapping tools used to inventory all of the influencers that could have an impact on a process you are trying to control.

  • Supplier - who are the internal and/or external suppliers of the process (material or data)?
  • Inputs - what are the inputs or triggers that prompt your process to act (material or data)?
  • Process - this is the process at hand that you are trying to illustrate for control or improvement
  • Outputs - what are the outcomes or results of your process (material or data)?
  • Customer - who is the internal and/or external customer(s) of your process that receive the outputs (material or data)?

For a more complex analysis of process influencers and impacts, the SIPOC diagram can be partitioned into various categories, similar to a fishbone diagram.  The illustration below prompts a process owner to consider elements such as the environment or "man" as having an effect on the performance of a process.

Management can use this tool to define relationships and expectations within the organization.  The SIPOC can also be used to analyze the variables that are not allowing the process to perform as well as expected.

Check back an examples of how this tool can be used to address order inaccuracies at ACME Burger Company and a link to our downloadable SIPOC tool in our next blog.

Turtle Diagrams (via Concentric Management Systems, Inc.)

After reviewing statistics from our website dashboard this morning, we were surprised to see that the #1 driver to our website is a search for the words "Turtle Diagrams". Special thanks to our friend - the turtle! For years now we have heard a handful of our customers fight with the concept of using a turtle diagram. Recently, I was in a heated discussion with an Engineering Manager who felt very strong about his position that "...turtle diagrams are a waste of time because they are only used during audits... to help an auditor be more efficient in his audit of us".

Well... yeah. I mean, PERFECTLY said (and thanks for making the argument easier for me Mr. Resister!). Turtle Diagrams at this organization were often only used by the auditors. But that doesn't mean that they were intended for the auditors. They were INTENDED for processes owners; a 1-page diagram that should be used to keep them on track with the expected outputs of the process they are responsible for. (Note: I said "process" they are responsible for and not "department" they are responsible for.)

Now, to address the portion of his statement: "...to help an auditor be more efficient in his audit of us". What's wrong with being efficient as an auditor? Furthermore, what's wrong with being efficient and organized as a process owner? The more focused you remain on the key deliverables, and the key resources needed to achieve these deliverables, the better chance you have at meeting the needs of your boss (your BOSS boss and your Customer).

Think of a turtle diagram as a point on the global when you go to Google Earth. Before you start navigating north, east, south or west, you first need to make sure you are on the right continent. From there, you can fine-tune and make adjustments. Start your process definition as a very high level. Gather all of the key resources, evaluate your strengths and weaknesses on the turtle and fine-tune from there.

For those of you who prefer a more mathematical explanation, work instructions are to assembly operators as turtle diagrams are to top managers responsible for the performance of a certain business process. Without identifying key outputs - critical to internal and customer satisfaction - it becomes difficult to align all of your tactical resources (man, machine, method, metrics, measurement systems, etc.) in order to achieve your strategic-level goals.

I encourage each organization that uses or considers using turtle diagrams to step back and evaluate the intent of this tool. Like any tool, turtle diagrams are only valuable if used as intended.

Turtle Diagram - Baking Process Example

Turtle Diagram - Baking Process Example

Instructions for Creating a Turtle Diagram 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. While there is no requirement per ISO 9001 or TS 16949 to create or manage turtle diagrams, I have worked with organizations who use turtle diagrams … Read More

via Concentric Management Systems, Inc.

Goal Converter

The best managers, coaches and teachers of the world have a common technique that helps to make their teams successful - the ability to convert a high-level organizational vision into tactical micro-level steps that utilizes the individual contributions of each teammate.

I'm pretty sure the goal of each NFL team at the beginning of the season is to win the Superbowl.  If the management of a NFL football team has only one goal for the team - "win the Superbowl" - what are the chances of actually realizing this goal?  Very slim.

The best managers, coaches and teachers of the world have a common technique that helps to make their teams successful - the ability to convert a high-level organizational vision into tactical micro-level steps that utilizes the individual contributions of each teammate.  A leader that is good at converting goals into actionable steps is a good leader.  It is not good enough to simply want to get to the top of the mountain.  Dozens, if not hundreds, of hours must be put into planning and preparation.  Any one of these preparation steps can make or break the mission.

Let's say that your organization has the following objectives in order to call the upcoming or current year successful:

  1. 90+% Customer Satisfaction Rating
  2. 90+% Employee Retention Rating
  3. 15+% Profit Margin

A simple tool, such as a Goal Conversion table, can break down the 15% profit margin goal into functional expectations for each key process within the organization.  Think Macro > Micro > Single Actions.  By using this table, along with a red/yellow/green indicator, the status of several different key processes are apparent.  Pat, the Process Owner for the Purchasing process, wants his box to be green.  It's currently yellow indicating an unfinished task or high risk action.

Let's imagine the current performance is around 12%.  How do you know?  That's right... because you have a simple measurement tool in order to track monthly profit margin.  This data is tracked by your accountant and provided to the Operations Manager by the end of the first week each new month.  Here is the long-term performance for the current year as well as notes recording significant events and their associated actions.

Charts and graphs are great.  But you need to be able to track which variables in the process have changed in order to control and improve process performance.  Use the table under the graph to help explain why your data has changed from one data point (monthly) to the next data point.  Action can also be recorded and linked back to the Goal Conversion Table (see Illustration #1 above).

There are few things in life more rewarding than doing a good job and visually seeing the fruits of your labor.  Screaming "Let's Win the Superbowl" louder while spitting in the face of your team members is not going to work (sorry Bobby Knight).  Clearly defining expectations - at relevant levels and functions to each player - and making performance monitoring simple works.

Interested in this concept?  Click here to open or download our Goal Converter tool.  It's free and simple to use.  Feel free to modify this as you see fit and give us your feedback on how this has helped your team realize it's goals.

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

Problem Solving Workshop

Concentric offers a state-of-the-art Problem Solving Workshop that can be used to both train employees on problem solving tools/methods while also solving the organizations most troublesome problems.  This is an outline for the 40-hour workshop:

 

Outline for Team Problem Solving Workshop

1.    The PDCA Cycle 
2.    Form a Team 
    a.  Who should be on the team?
    b.    How the team should be organized
    c.    The Team Leader
    d.    Responsibilities of team members
    e.    Consequences if this step is skipped
3.    Define the Problem 
    a.    Using the 5W2H method
    b.    Tools to use
    c.    Determining if the problem is related to measurement (MSA) or process 
    d.    Consequences if this step is skipped
4.    Containment Action 
    a.    Protecting the customer
    b.    Validating the action
    c.    Verify that the containment action works
    d.    Consequences if this step is skipped
5.    Find the Root Cause: Tools and Techniques 
    a.    Tools to use (Ishikawa “Fishbone” Diagram, Brainstorm & Rank)
    b.    The 5 Why’s - Ask why five times
    c.    Is/Is Not Tool
    d.    Consequences if this step is skipped
6.    Corrective Action 
    a.    Action, responsibility, due date
    b.    Verify that the corrective action effectively addresses the cause(s)
    c.    Improve the quality system by looking at all aspects of the quality system 
    d.    Consequences if this step is skipped
7.    Evaluate effectiveness & Corrective Action Impact 
    a.    Monitor/Evaluate long-term effectiveness
    b.    1st Piece verification + Last-off comparison
    c.    Process audits
    d.    Application of actions taken to similar products or processes
    e.    Consequences if this step is skipped
8.    Preventive Action 
    a.    What is preventive action (vs. corrective action)?
    b.    Preventive action tools & techniques
    c.    Use of C&E Matrix to prioritize by highest risk
    d.    Deep dive into FMEA
9.    Management Review 
    a.    How to structure a follow up meeting
    b.    Reporting the status of Corrective & Preventive Action
    c.    What should management review?
    d.    Consequences if this step is skipped
10. Improving the Problem Solving Process
    a.    Using PDCA to improve the Team-based problem solving process
    b.    TGR/TGW Analysis
    c.    Evaluating the tools & techniques used
    d.    Reporting results to top management
    e.    Evaluating management commitment
    f.     Updates to procedures
    g.    Identification of new training & competency needs
    h.    Other resources needed for continual improvement