So there you are leading beautifully. Your organization is totally immobile, and your vision is totally still.
AYCHConsultant is introducing to you an innovative approach to deal with nonconformities.
Once a problem has been identified through inspection, customer complaints, or audit results, it should be captured using non-conformity reports (NCRs) or corrective action reports (CARs) in order to identify who is affected by the problem and what the impact is. Considering the following:
This step helps to fully describe a situation, precisely analyse all its elements and gain a common understanding of them, allowing the definition of an action plan. Ensure that all team members agree about the definition of the issue and resulting impact.
The problem description should describe the problems in terms of what, where, when, and how big. On a flip chart, presentation board, or even paper; write out a description of what you know about the problem. Try to document the problem and describe it as completely as possible.
The description should contain facts; such as observations and documentary evidence and not assumptions. All information must be gathered before identifying the root-cause can begin.
Make sure both of the above factors are true before you move to the next step. Consider any new information that the team may have gathered since completing the initial problem description.
Describe the problem by identifying what is wrong and detail the problem in quantifiable terms. Define, verify and implement the interim containment action to isolate the effects of the problem from any internal/external customer until Permanent Corrective Actions (PCA) are implemented.
Identify representatives from functions that may have an influence on the corrective action process, including the identification of the root causes. Remember to assign responsibilities and objectives to the team members.
Remember, those performing the job, such as operators, inspectors, drivers, etc., are the best people to help identify the real causes, don’t leave them out of the team!
The size and composition of the team should depend on the complexity and the impact of the problem. The composition of the team is not fixed forever and may evolve depending on the analysis results and the required actions.
New team members should join the team if analysis shows they are identified as being in the scope, some others will leave if their area is definitely identified as out of the scope.
However, consideration should be made that expending the size of the core team over 6 to 8 members generally results in less efficiency. When more members or special skills are required, sub teams should be considered. Don’t forget, root-cause analysis must not be used for assigning blame or transferring responsibility. In summary, you should establish an investigation team with:
Brainstorming sessions should be used to identify potential causes to investigate each potential cause. Coordinate parallel activities with different team members to help expedite the process of verification.
Once you have reviewed the problem description, you can undertake a comparative analysis. A comparative analysis will help you identify relevant changes in a change-induced situation. Then you can reduce the number of possibilities that you must consider to determine root-cause. To complete a comparative analysis:
If the problem is change-induced, the root-cause must be the result of a change relative to one or more of the identified changes. It is important to remember that you have not yet moved from the ‘observations’ phase of the process.
Any information you develop during the comparative analysis must be fact based, not opinion based and must be true only for the symptom’s information. Do not rule out any facts that might be valid answers. If it is a fact and it answers the question, write it down. Your organization should first contain the problem by taking immediate corrective action (ICA) and then evaluating the need for initiating the formal problem-solving process.
Where necessary, provide an emergency response action to protect the customer from the problem, protect the customer operations and the organisation (to stop the problem getting worse) and verify that problem does not degrade until the root-causes are known.
An interim containment action is kept in place until a verified permanent corrective action can be implemented. In some cases, the interim containment action may be the same as or similar to the emergency response action. An interim containment action provides more opportunity for investigation.
Conduct trial runs whenever possible. However, in some situations, your verification may simply be a matter of common sense. For example, if an interim containment action involves stopping the shipment of all products, you can be sure that customers will stop experiencing the problem.
An interim containment action can be any action that protects the customer from the problem. However, before you implement an interim containment action, you need to verify that the interim containment action will work. To verify the interim containment action:
Methods of verification may include:
Any interim containment action you implement must protect the customer from the problem without the introduction any new problems. Also, a single interim containment action may not be enough. You may need to implement more than one interim containment action to fully protect the customer.
Root-cause analysis (RCA) is a class of problem-solving methods aimed at identifying the root-causes of problems or events. The practice of root-cause analysis is predicated on the belief that the problems are best solved by attempting to correct or eliminate root-causes, as opposed to merely addressing the immediately obvious symptom.
Launching a formal root-cause analysis and problem-solving process should always be considered when an issue; such as, undesirable conditions, defects and failures are detected. The decision not to apply the process must be made based on objective evidence of absence of risks!
When all root and contributing causes have been identified and their effects understood, implement all selected corrective actions. Verify that the planned actions were taken as scheduled and assess their effectiveness in permanently preventing the undesirable condition, situation, non-conformity or failure from recurring. Steps for permanent corrective action (PCA) implementation:
Implement the permanent corrective action (PCA); Implement controls; Evaluate the permanent corrective action (PCA) for escape point; Remove the immediate containment action (ICA); Perform validation; Confirm with the customer that the symptom has been eliminated. To ensure the most effective corrective actions to address the most likely, or critical root causes are taken in consideration of operational and business constraints such as costs, lead time, difficulty of implementation, and resources. Select solutions that optimise value and effectiveness for all stake-holders!
Implement the solutions that have been selected, verify that all actions have been completed to schedule and that they have prevented the undesirable condition, situation, non-conformity or failure from recurring. Plan and implement selected permanent corrective actions. Remove the interim containment action and monitor the long-term results.
Modify the necessary systems, policies, practices and procedures to prevent recurrence of this problem and similar ones. Make recommendations for systemic improvements as necessary:
Serious consequences may occur when the underlying symptoms are not addressed, when the quick fix is accepted as a final, permanent solution. Excessive reliance on containment or emergency response action will create a repeating cycle. Problem containment is an addiction that will only get worse until the root-causes are found and addressed.
Establish a review process to ensure corrective actions are completed according to plan and that they continue to be effective over time by confirming you have done what you have planned. Try adjusting the type and number or frequency of additional checks and audits to check that the actions remain effective.
When same problem has been identified or is suspected to occur on same or similar products, processes or data, the same corrective actions must be implemented and their effectiveness verified for all these additional products, processes or data.
The owner of each corrective action, the team leader and all team members should verify the effectiveness of the actions taken to date, and when relevant, the customer. Examples of verification methods include:
Examples of supporting evidence might include: updated procedures, work instructions, control plans, etc. to show any changes were defined. Additionally, evidence of effective implementation of the changes is also required such as SPC data, inspection records, training records, audit records, etc.
If the corrective actions are effective, evaluate which containment actions may be eliminated (e.g. stop over inspection and over production, return to normal transportation means, etc.) without adversely affecting the product and process output. Record evidence of actions completed and associated results (what works and what does not).
To document analysis results and changes to make the corrective action permanent, capture and share learning with all the stakeholders to prevent similar undesirable condition, situation, non-conformity or failure occurring on other products, production lines, factories or suppliers.
Identify all that can be shared from the experience that can be transferred across business units, production lines, factories or suppliers. Ensure that you get agreement from appropriate levels of management and other process owners and functions (internally and externally) to launch actions and verify there are implemented and effective.
Keep lessons learned register which includes a summary of content and results of analyses, flow charts, data bases, performance data, main actions and decisions, location where detailed data can be retrieved, difficulties encountered when managing the issue, etc.
When the decision is made to implement actions in another business areas, such as; production lines, factories or suppliers, which are not under direct control of the response team, implementation and the verification of effectiveness is not necessarily the responsibility of the team.
Escalation to top management or transfer to another function (procurement, engineering, etc.) may be required to ensure proper leverage and action follow-up.
AYCH “leadwise” principle is not a game.
[Sources: iso9000 family, isoorg, ]