Friday, 4 January 2013

Corrective Action Challenge-How to construct a robust problem-solving process

Corrective Action Challenge

How to construct a robust problem-solving process

by R. Dan Reid
Recent data for ISO Techinical Specification (TS) 16949 global certification audits show that clause 8.5.2, corrective action, is the one most frequently cited for major nonconformities, and it’s eighth on the list for minor ones.
In addition to the ISO 9001 requirements, ISO/TS 16949 requirements for this clause include sub-elements for:

Problem solving.
Error proofing.
Corrective action impact.
Rejected product test and analysis.

Clause 8.5.2.1 of ISO/TS 16949 requires that organizations "have a defined process for problem solving, leading to root cause identification and elimination."
In 2011, automakers expressed concern to the Automotive Industry Action Group (AIAG) about the capability of the supply chain to perform effective root cause analysis. This led to the initiation of a new AIAG project that recently produced two new effective problem-solving guides—one for practitioners (AIAG CQI-20) and one for leaders (AIAG CQI-21).

Table of elements

In the spirit of these new documents, let’s examine the common elements of a disciplined problem-solving process:
Problem identification. This critical step is often poorly executed. As Albert Einstein said, "the mere formulation of a problem is far more often essential than its solution, which may be merely a matter of mathematical or experimental skills."¹
Prior to developing a problem statement, evidence should be collected from the location where the problem was discovered or occurred. Facts should be gathered using the 5W2H model.² The problem statement should properly identify the problem, not just its symptoms. This is the first of several areas likely responsible for ISO/TS 16949 audit nonconformities.
Correction or containment actions. Clause 3.6.6 of ISO 9000 defines correction as "action to eliminate a detected nonconformity." In a typical disciplined problem-solving process, however, correction or containment is better defined as immediate actions taken to address the symptoms of a detected nonconformity.
Containment is not problem solving. The process shouldn’t stop with containment of the problem. Containment actions are necessary to stop the bleeding and to protect the customer. Containment actions taken also should be focused, temporary and extraordinary. Actions taken should stay in place until the effectiveness of the corrective actions is verified.
Often, the problem is a lack of competent resources available to properly complete the problem-solving process. As a result, practitioners move from problem to problem because they only have time to address containment.
Top leadership is responsible for ensuring the necessary resources are available to execute the strategic and tactical plans (see clause 5.1 of ISO/TS 16949). This includes support for employees in their problem-solving activities—adequate training, technical coaching, additional competent resources as needed and adequate time for problem solving.³
Root cause analysis. Effective root cause analysis addresses three types:

Escape root cause addresses the question, "Why did the concern reach the customer or next operation?"
Occurrence root cause addresses the question, "Why did the problem occur?"
Systemic root cause addresses the question, "Why did the system or planning process fail to identify a concern?"⁴

Various tools can be used at this step—more than can be addressed here. AIAG CQI-20 provides more information. Missing or poorly executing this step is likely responsible for many ISO/TS 16949 audit nonconformities.
Corrective action. Clause 3.6.5 of ISO 9000 defines corrective action as "action to eliminate the cause of a detected nonconformity or other undesirable situation." The purpose of corrective action is to prevent the recurrence of the problem. There are usually many actions that can be taken to address the problem, ranging from incremental changes to innovative solutions requiring use of innovation methods, a field that has evolved significantly over time.
In some cases—such as those involving complex problems—innovation may actually be necessary to find a solution after the root cause is confirmed. Hence, innovation is becoming a necessary competency for the problem-solving tool kit. The right solution is usually determined by considering the cost and resources required, and the time available to find the best solution.
Verification of effectiveness. No disciplined problem-solving process is complete without verifying the effectiveness of the corrective actions taken. Those who discovered and were affected by the problem must be consulted to confirm the effectiveness.
Error proofing. Clause 8.5.2.2 of ISO/TS 16949 requires the organization to use error-proofing methods in the corrective action process. There are still many opportunities in manufacturing processes to incorporate provisions that prevent defects from getting to a customer. In the automotive field, error proofing has been contrasted with mistake proofing, but both should be considered and implemented where feasible.
Error proofing is action applied to the design to prevent errors from occurring, while mistake proofing is action typically applied to the process to prevent the cause of the mistake, shut the process down if the mistake occurs or trigger an alarm if the mistake occurs.⁵ Failure to implement such provisions also may contribute to ISO/TS 16949 audit findings.
Corrective action impact. Clause 8.5.2.3 of ISO/TS 16949 requires organizations to apply effective corrective action to other similar processes and products, preventing the occurrence of a similar problem. Typically, this is done in the spirit of preventive action (see clause 8.5.3 of ISO 9001).
In its August 2012 meeting, the U.S. Technical Advisory Group to ISO Technical Committee 176 began work on a U.S. position for addressing confusion about the difference between corrective and preventive actions. One proposal is to eliminate the term "preventive action" in the next version of ISO 9001. Clearly, the term has become associated with the reactive corrective action process taken in response to the occurrence of a problem.
Quality planning is the ultimate preventive action (see Figure 1). Clause 3.2.9 of ISO 9000 defines quality planning as "part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives."

Figure 1

Quality planning also can be defined as actions taken to prevent or mitigate nonconformity. This can be seen in various ISO 9001 activities that must be done "in accordance with" or to verify compliance with "planned arrangements" (clause 7.3.1). These activities include:

Design and development review, clause 7.3.4.
Design and development verification, clause 7.3.5.
Design and development validation, clause 7.3.6.
Internal audit, clause 8.2.2.
Monitoring and measurement of product, clause 8.2.4.

The most effective time to plan and implement actions to prevent problem occurrence is prior to product or service launch. Figure 1 shows how preventive action has been relegated to a reactive position relative to problem occurrence, largely due to its link to corrective action in the same ISO 9001 clause.

A path forward

In the next revision of ISO 9001, perhaps the term "preventive action" should be replaced with "quality planning" and a revised definition such as "actions taken to prevent nonconformity or mitigate potential nonconformity."
If this is done, another term should be used to refer specifically to deployment of effective corrective actions across similar processes and products so as to not lose this concept. Either that, or the term "corrective action" should be redefined to include this activity.
If the term "preventive action" is retained in the next revision of ISO 9001, it should be redefined as the deployment of the corrective actions described. Either way, quality planning should be positioned as the primary preventive action element going forward.
Further, there should be a more explicit feedback requirement from a problem occurrence to the quality planning process so any deficiencies in the upfront planning process of product or service launch can be addressed. Currently, this doesn’t occur often.
With regard to the numerous ISO/TS 16949 audit nonconformities that cite the corrective action clause, leadership should take note. Quality pioneers W. Edwards Deming, Joseph M. Juran and Philip B. Crosby began their careers as quality practitioners and statisticians. As their experience grew, they shifted their attention from quality tools to leadership and creating an organizational culture in which quality can be nurtured and achieved.
It’s no different today. Deming pointed out that the commitment of top management to quality and productivity is not enough. "They must know what it is that they are committed to—that is, what they must do. These obligations cannot be delegated. Support is not enough. Action is required."⁶ This includes:

Communicating a well-thought-out, long-term vision for the future.
Establishing and maintaining a culture for effective problem solving (see AIAG CQI-21).
Developing strategic and tactical plans for accomplishing the vision.
Allocating adequate competent resources for internal and supplier quality.
Understanding and reinforcing the organization’s disciplined problem-solving process by asking the right questions and requiring its use by everyone.
Empowering people to act within established policy, processes and procedures.
Providing what Deming called constancy of purpose.
Ensuring the problems are, in fact, solved—not just contained.

References and note

Quoteworld, "Albert Einstein," www.quoteworld.org/quotes/4087.
This approach involves asking who, what, where, when, why, how and how much.
Automotive Industry Action Group, Effective Problem Solving Leader Guide, 2012, clause 1.4.2.
Automotive Industry Action Group, Effective Problem Solving Practitioner Guide, 2012, clause 2.4.2.
Automotive Industry Action Group, Subtier Supplier Management Process Guideline, 2012.
W. Edwards Deming, Out of the Crisis, MIT Press, 1982.

Bibliography

International Organization for Standardization, ISO/TS 16949:2009—Quality management systems—Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations.
International Organization for Standardization, ISO 9000:2005—Quality management systems—Fundamentals and vocabulary.
International Organization for Standardization, ISO 9001:2008—Quality management systems—Requirements.

R. Dan Reid is a quality program manager at the Automotive Industry Action Group (AIAG) in Southfield, MI. An ASQ fellow and ASQ-certified quality engineer, he is the co-author of ISO 9001:2000; QS-9000; ISO/TS 16949; the Chrysler, Ford and GM Advanced Product Quality Planning and Control Plan, Production Part Approval Process and Potential Failure Modes and Effects Analysis manuals; ISO IWA 1; and AIAG’s Business Operating Systems for Health Care Organizations.

Friday, 4 January 2013