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William A. Levinson, P.E.  Principal
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TheBoss at ct-yankee.com
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ISO 9000 PowerPoint training package

Closed-Loop Corrective Action: a vital element of ISO 9000


ISO 9000
Costly and time-consuming obligations or profitable elements of your quality managment system?
Picture of workers carrying an elephant
Does your organization see ISO 9000 as an onerous burden it "has to carry" to satisfy customers?
Pictures of workers riding an elephant

Maybe it's simply not being used the right way.


  • Don't just comply with ISO 9000, train your front-line workers to use ISO 9000 to improve the system in which they work.
    • Levinson, ISO 9000 at the Front Line
    • Levinson Productivity Systems offers a Microsoft PowerPoint presentation designed for a one-day course, and can present this to your employees.
  • Henry Ford showed why ISO 14000 should be not only free but profitable. He saved money by (1) not making the environmental waste in the first place or (2) turning what would have been waste into products.
ISO 9000: Use it proactively to drive continuous improvement and cost reduction
171 PowerPoint slides (including Notes pages for handouts), $85.00

What your participants will learn:
This 4-5 hour overview of ISO 9000 is designed primarily for manufacturing engineers, supervisors, foremen, and shop personnel. This course goes beyond a mere technical overview of the standard by explaining how its proper use is profitable, and it emphasizes the front-line worker's role in using ISO 9000 to improve the system in which he or she works. This makes ISO 9000 the organization's servant instead of its master, and a money-saver instead of a costly annoyance.

1.     
What is ISO 9000?
  o       ISO 9000 is an international standard for quality management systems (QMSs)
  o       ISO 9000 is a moneymaker (as opposed to a costly annoyance) if used properly.
  o       ISO 9000:2000 is process-oriented
2.      The Front-line worker's role in ISO 9000
  o       The organization must empower the front-line worker through appropriate training and infrastructure (e.g. the ISO 9000 hiyari or scare report).
3.      Friction: the Hidden Enemy
  o       This also is known as muda or waste. It is often overlooked because people become used to working around it.
  o       ISO 9000 as a "proactive servant" that eliminates friction, instead of a "reactive master" to which the organization responds only when a required internal or third-party audit finds a problem.
4.      Provisions and Requirements
  o       How it works: "Say what you do, and do what you say."
  o       Document hierarchy
5.      Management Responsibility (ISO 9000:2000 section 5)
6.      Resource Management (6)
7.      Product Realization (7)
8.      Measurement, Analysis, and Improvement (8)
The course includes an in-depth discussion of closed-loop corrective action and closed-loop proactive action.


Closed-loop corrective action: a vital element of ISO 9000
Closed-loop corrective action, a form of Plan-Do-Check-Act (PDCA), is vital if one is to use ISO 9000 as a proactive improvement tool.
We cannot overemphasize the importance of following through on every problem and proactive improvement project. Corrective action is required by ISO 9000.
  • Lack of follow-through will undermine employee confidence in the program.
  • Example: TOPS-8D gets to 2D or 3D
  • Follow-through on every project will encourage employee participation.
All closed-loop corrective action systems are extensions of the familiar plan-do-check-act (PDCA) improvement cycle.
They can be easily adapted for closed loop preventive action and closed loop proactive action.

The Ford Motor Company's Team-Oriented Problem Solving, Eight Disciplines (TOPS-8D) Six Sigma DMAIC
Corrective action: Project initiation
  • Quality problem: scrap, rework, field failure
    • Or employee-initiated hiyari (scare report) that identifies a potential problem source
  • Equipment downtime
    • National Semiconductor, Ford River Rouge: no such thing as a "minor" equipment stoppage
  • Six Sigma gap analysis (quality-related)
  • ISO 9001:2000 or ISO/TS 16949 audit finding
  • Employee-initiated quality system hiyari (scare report)
    • Recommended procedure: all employees should be trained and empowered to understand the quality management system and file a quality system hiyari when they see a nonconformance or potential nonconformance.
    • Each hiyari is reviewed by a qualified person, such as a trained internal auditor. If the hiyari does indeed identify a quality system nonconformance, it has exactly the same effect as an actual finding during an internal or third-party audit.
Proactive action: Project initiation
Remember that a considerable amount of waste (muda) can exist in an ISO 9000:2001 or ISO /TS 16949-compliant system.
  • Employee-identified improvement opportunity
  • Management-initiated improvement, e.g. based on formal value stream analysis or gap analysis
  • Kaizen blitz
It may be argued that traditional Six Sigma is reactive in nature because DMAIC projects are triggered by gap analysis (i.e. identifiable gaps between actual and desired performance), and its heavy emphasis of  metrics means that improvement opportunities may be overlooked.
  • Six Sigma financial metrics and gap analysis can initiate projects.
  • Quality and service problems also can initiate projects.
(1) Form an appropriate cross-functional team. (Plan)
8D and Six Sigma teams include champions (process owners with the resources and authority to implement the team's decisions), subject matter experts, facilitators, team leaders, and front-line workers with hands-on experience.
Form an appropriate cross-functional team. (Plan)
Six Sigma Black Belts serve both as facilitators and subject matter experts, with expertise in Design of Experiments and other problem-solving techniques.
(2) Define the problem. (Plan)
The importance of a clear definition of the problem cannot be overemphasized. Far too much time is often wasted on solving the wrong problem! This can include treating the symptoms instead of the underlying root cause.
Define the problem. (Plan)
Measure the activity involved, which may be a core business process. (Plan)
(3) Contain the problem. (Protect the customer.)
Containment, in the form of segregation of nonconforming product, is mandatory under ISO 9001:2000 and ISO/TS 16949
Not applicable
Analyze. Prioritize improvement opportunities and identify variation sources. Identify and implement appropriate statistical procedures. (Plan)
Six Sigma places a heavy emphasis on Design of Experiments along with traditional problem-solving tools. It must be emphasized, however, that many lean manufacturing improvements along with error-proofing, autonomation, and so on involve no statistics at all.
(4) Identify the root cause. (Plan)
This may also be regarded as a miniature PDCA cycle in which experiments are planned, carried out, and assessed to see if they deliver the desired results
(5) Select a permanent correction. (Plan)
(6) Implement the corrective action (Do) and verify its effectiveness (Check). Improve. Identify and implement the changes (Do) and verify their effectiveness (Check).
(7) Make the change permanent (standardization). (Act)
Under ISO 9001:2000 and ISO/TS 16949, this will include updating work instructions and procedures to prevent back-sliding. This is a principal focus of standardization.
In addition, be sure to share the project and the results with other areas of the business. This is known as best practice deployment. Levinson Productivity Systems recommends placing all completed 8D (or DMAIC) projects in a keyword-searchable data base so other process owners and work areas can search for keywords related to their own operations and problems.
Control. Implement controls to hold the gains and prevent backsliding, as described at left (Act).
(8) Recognize the team's achievement



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