Problem-Solving Technique: Step 5- Effectiveness Evaluation (Corrective Action)

“Do the best you can until you know better. Then when you know better, do better" – Maya Angelou.

Introduction

When an organization identifies the training needs and provides the training to the concerned person, the next logical step is to verify the effectiveness of the training. There can be various ways to monitor the effectiveness. It helps the organization to understand whether the purpose of imparting the training has been fulfilled or not.

Objective

The purpose of a quality management system is to help businesses improve their abilities to consistently meet customer or regulatory requirements. A major component of a successful system is a corrective action program that adequately addresses nonconformances. Quality pioneer W. Edwards Deming introduced the Plan-Do-Study-Act (PDSA) cycle as a planning, implementation, and continuous improvement tool.

In the problem-solving technique (like the 8D Model), one of the most pertinent steps is to take appropriate corrective action and ensure that it is effectively implemented.

Determining the best verification approach for the wide range of problems that could occur can often be challenging. Both qualitative and quantitative methods can be used to measure the success of a proposed Corrective Action. Qualitative methods explain and gain insight and understanding of an issue through the intensive collection of narrative data, and generate a hypothesis to be tested. Quantitative methods explain, predict, and/or control phenomena through the focused collection of numerical data and hypothesis testing.

Definitions (ISO 9000: 2015):

Complaint (clause 3.9.3): Expression of dissatisfaction made to an organization related to its product or service or the complaints handling process itself where a response or resolution is explicitly or implicitly expected.

Complainant (clause 3.1; ISO 10001: 2018): Person, organization or their representative making a complaint.

Corrective Action (Cl 3.12.2): Action to eliminate the cause of nonconformity and to prevent reoccurrence.

Correction (Cl 3.12.3): Action to eliminate a detected nonconformity

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Detailed Information:

The following are the 7 key steps for problem-solving.

1.?????? Define the Problem

2.????? Correction, Containment, Interim Action

3.????? Root Cause Analysis: 3 Layered 5 Why Analysis (3L5Y), Ishikawa Diagram, PDCA

4.????? Implementation of Corrective Action?

5.??? Effectiveness Evaluation

6.????? Horizontal Deployment

7.????? Documentation, Lesson Learned and Promotion of Awareness

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Effectiveness Evaluation

Once the organization implement the Correction and Corrective Actions (Do), as per the PDCA cycle, the next logical and important step is to verify their effectiveness (Check).

Remember, the corrective action is something, new or additional, that would eliminate the issue from coming up again in the future. Subsequently, corrective action must be identified for every correction identified. Verifying the effectiveness of action closes the loop between identifying a problem and completing the actions to solve a problem.

The exact amount of evidence depends on the magnitude of the problem. Broader and more severe problems lead to more profound solutions, which in turn require more evidence to verify effectiveness.?The key to verification is evidence. You are seeking objective, factual and impersonal evidence that your problem causes have been reduced or removed.

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3 Key Purposes of Effectiveness Evaluation:

• To build confidence that the solution will work
• To validate that the solution did work
• To minimize any risks or potential problems that might cause reoccurrence

Example:

Problem: 100 assemblies (moulded components) were rejected at the customer end (OEM) due to fitment issue

Correction and Corrective Action:

a.????? 100% segregation done at the organization, supplier and customer end

b.????? Further, despatch to the customer stopped

c.?????? The moulding fixture was modified and the moulding process parameter was reviewed and updated. A new moulding fixture will be made to control the specifications.

d.????? Alternate moulding machine (800T) to be qualified for further production

e.????? Communication to the supplier, incoming/in-process/final inspection

f.??????? Incoming, in-process and final inspection check-sheet reviewed and updated

g.????? All the documents reviewed and updated (PFC, PFMEA, Control Plan, SOP, supplier PPAP)

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13 Verification Steps:

1.?????? Whether implemented: The above corrective actions are implemented or only on paper (go to Gemba and check like many government projects like roads)? ?

2.????? Whether Practical to Implement: Whether the proposed corrective action is practical to implement or not (Segregation done at customer/supplier end but both are not in the country or there is no moulding machine of that capacity in the organization)?

3.????? Whether Communicated: All the stakeholders like the operator, engineer, supervisor, supplier, customer etc. are communicated about the action plan (Like many companies, the action plan is made on the computer and shared with the customer as a similar type of problems have repeated many times)?

4.????? Whether Resources provided: The desired resources are provided to the process owner like gauges, fixtures, tooling, training, measuring instruments etc. (The new fixture is indented but still struck with the Purchase process for approval)?

5.????? Whether Timeline defined: Any timeline is defined for its implementation (the new moulding fixture will be procured but by when!!)?

6.????? Whether the Quantity in the process identified: How much quantity is in the process which needs to be consumed before the implementation will start or to be scrapped (Approximately 1000 pieces are at the supplier end, 2500 at the organization end, 1000 in the transit warehouse and 500 at the customer end. How to handle this material)?

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7.????? Whether Documents updated: All the relevant documents like PFC, PFMEA, Control Plan, SOP, Supplier PPAP etc. are reviewed and updated as per the action plan (Supplier PPAP reviewed or not, Shop floor SOP is updated but what about PFC, PFMEA and Control plan)?

8.???? Whether Validation is done: The process and product are to be validated after implementation of the proposed action plan. If yes, whether, it is meeting the requirement (Number of pieces rejected before the corrective action implementation and comparing it after the implementation)?

9.????? How are Identification and Traceability defined: The product manufactured after the implementation of the corrective action is identified and its traceability is ensured while shipping it to the customer (Identification mark on the old material and the material after modification with colour code or marking)?

10.? Whether Customer Feedback is taken: Any feedback is taken from the customer about the effectiveness of the proposed corrective action (Whether the customer is satisfied with the product after the fixture and process change, any mixing of the old product, or any new problem has emerged)?

11.?? Whether Effectiveness Verified over a timeline: Do we have a process to see the effectiveness of the implemented action plan for a certain timeline or quantity (whether a similar problem is repeated from the same or a different customer, are we communicating with the customer to get their feedback)?

12.? Effectiveness of Internal Audit Process: Whether the System audit, Manufacturing Process audit, Product audit, or Layered audit is in place to verify the effectiveness of the action plan (Whether the audits verify the customer issues or not, whether the checklist is getting updated or not)?

13.? Involvement of? Top Management: If the top management is communicated about the effective implementation of the corrective actions and resultant cost incurred (If the management is interested in the customer issues, whether they are also tracking the effectiveness of action and customer satisfaction).

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If the corrective action is ineffective, it should be reevaluated until it is effective, revised and its implementation reverified. Following are some of the key principles that can be implemented to ensure effective implementation

1.?????? Effective Planning ensures success

2.????? Communicate clearly and often

3.????? Stay focused on the root causes

4.????? Thinking out of the box

5.????? Make change happen

Industry Challenges:

• How often do the organizations have a process to verify the effectiveness of the proposed corrective action plan?
• How often is the non-compliance with corrective actions escalated to the top management?
• How often the annual performance of the employees is judged based on the effectiveness of the corrective actions? ?

References:

IATF 16949: 2016

ISO 9001: 2015

ISO 9000: 2015

OEM Supplier Manual

CQI 20: Aug 2018, 2nd Edition (Effective Problem-Solving Guide)

Industry Experts