ISO 9001:2015 Improvement

10.1 General

The Requirement

The organization must determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These actions must include improving products and services to meet requirements, as well as, address future needs and expectations; correcting, preventing, or reducing undesired effects; improving the performance and effectiveness of the quality management system. Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation, and reorganization.

Checklist Questions

1. How does the organization determine and select opportunities for improvement?
2. What necessary actions have been implemented to met customer requirements and enhanced customer satisfaction?
3. Show how has the organization Improved processes to prevent nonconformities;
4. Show how has the organization Improved products and services to meet known and predicted requirements;
5. Show how the organization Improved QMS results.

Implementation Guidelines

1. Process improvement, product improvement, and management practices improvement must work together towards improving the organization as a whole, working towards a common aim.
2. Based on the results of the management review, the organization must make decisions and take actions that will drive it towards continual improvement. Those actions can be in the form of corrective actions, training, reorganization, innovation, and so on.
3. There is now a requirement for organizations to focus clearly on customer satisfaction and customer needs by improving:
   a) products and services, now and for the future;
   b) fixing and controlling business issues to reduce things going wrong and improving the QMS
4. Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization (e.g. transformation).

10.2 Nonconformity and Corrective Action

The Requirement

10.2.1

When a nonconformity occurs, including any arising from complaints, the organization must react to the nonconformity and, as applicable take action to control and correct it; and deal with the consequences. The organization must also evaluate the need for action to eliminate the causes of the nonconformity so it does not recur or occur elsewhere, by reviewing and analyzing the nonconformity,  determining the causes of the nonconformity, and determining if similar nonconformities exist, or could potentially occur. The organization must implement any action needed and review the effectiveness of any corrective action taken; It must update risks and opportunities determined during planning, if necessary and make changes to the quality management system, if necessary. The corrective actions must be appropriate to the effects of the nonconformities encountered.

10.2.2

The organization must “retain” documented information as evidence of the  nature of the nonconformities and any subsequent actions taken and  results of any corrective action.

Checklist Questions

1. When any nonconformity (including complaints) occurs, how does the organization take action to control and correct it and deal with the consequences?
2. When any nonconformity (including complaints) occurs, does the organization evaluate the need for action to eliminate the causes of the non-conformity?
3. How does the organization reviews and analyzes the nonconformity?
4. How does the organization determine the causes of the nonconformity?
5. How does the organization determine similar nonconformity exist or could potentially occur?
6. How does the organization implemented any action needed?
7. How does the organization reviewed the effectiveness of the corrective action taken?
8. How does the organization updated risk and opportunities determined during planning if necessary?
9. Has the organization made changes to the QMS if necessary?
10. Show how correction actions were appropriate to the effects of the nonconformities encountered.
11. What documented information can you show as evidence for the nature of the nonconformities and subsequent actions taken and the results of any corrective action.

Implementation Guidelines

1. Corrective action is the action taken to eliminate the cause of a detected nonconformity to prevent a recurrence, whereas preventive action is the action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence.
2. Corrective action can reduce the likelihood of recurrence to an acceptable level.
3. In some instances, it can be impossible to eliminate the cause of nonconformity.
4. Your corrective action process must address the following control requirements:
   a) Identify detected nonconformities that relate to your products, QMS processes, resources, suppliers and outsourced work, product shipped to customers, customer complaints, cost of quality reports, and things went wrong reports.
   b) Define your process for identifying nonconformities and consider using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity
   c)Problem-solving tools may include analysis of failure mode, capability studies, correlation diagrams, data collection, fishbone diagram (Ishikawa diagram), histograms, Pareto analysis, probability charts, stratification of data, graphic representations, etc. Ensure that personnel applying these tools are competent and trained.
5. Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to product, process, resources, documentation, controls, etc. or any combination of these. Conduct follow-up tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented recurrence.
6. Evaluate the significance of nonconformities in terms of their impact on operating costs, cost of nonconformity and its correction, product performance, safety, dependability, regulatory requirements, the effect on customer’s products and processes, any other risks, and customer satisfaction.
7. You must update risks and opportunities. Keep records of all non-conformities, what you did to resolve them, implement additional measures, follow-up action, etc
8. You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of the root cause may have been incorrect or incomplete. Keep appropriate records of all corrective action steps.

10.3 Continual Improvement

The Requirement

The organization must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organization must consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that must be addressed as part of continual improvement.

Checklist Questions

1. Demonstrate that you continually improve the suitability, adequacy, and effectiveness of the QMS.
2. Demonstrate that outputs of analysis and evaluation and the outputs from management review are considered to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement.
3. What applicable tools and methodologies for the investigation of the causes of underperformance and to support continual improvement are selected?

Implementation Guidelines

1. The continual improvement process can be conducted by small-step ongoing improvement activities conducted by personnel within existing processes (Kaizen Events).
2. Useful tools that are often used to continually improve, include capability studies, design of experiments, risk analysis, SPC, supplier evaluation, test and measurement technology, the theory of constraints, overall equipment effectiveness, technology, benchmarking, analysis of motion/ergonomics, and error-proofing. Ensure that personnel applying these tools are competent and trained.

Documented Information if applicable

1. NCR status Log
2. Non Conformance Report

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