ISO 9001 Clause 10. Improvement

Improvement is simply an act or a process of making something better.

ISO 9001 Clause 10, which is the last clause of ISO 9001, talks about Improvement, which describes the action steps that an organization shall take to improve their processes, products and services. This clause also describes the process for addressing nonconformities and taking corrective actions to eliminate the root causes as the first step in acting to improve the system. ISO 9001 also requires that the process improvement should not be a one-time activity but should be in-built into the process so that a mechanism of continual improvement is established.

Why is it important?

Today’s world of business is highly competitive; customers have high demands, and they cannot be pleased with just their requirements being met; they want value for money. Companies must bring in differentiating factors in their business to ensure they surpass customer expectations. The differentiating factors can be built-in by delivering faster than others, selling goods of high quality, quick and easy-to-reach after-sales staff, etc. All these need process improvements, which could be bought in by removing the waste or unwanted processes to move the goods faster or by improving your supply-chain processes, ensuring good quality raw material through detailed inspections, etc. This is where your continual-improvement efforts should be focused at. Continually improving the processes is how you create excellence and become highly competitive.

How to identify improvement opportunities?

Clause 10.1 emphasizes the need for an organization to seek out and realize improvement opportunities that will enable the organization to meet customer requirements better and enhance their customers' satisfaction.
When looking to improve, organizations should review their processes, improve their products and services, correct, prevent or reduce undesired effects and improve their QMS results. This clause adds that organizations should not only improve products and services to meet known requirements but also address the “future” needs and expectations of the customer.
Improvement opportunities may be identified at various places throughout your organization's processes. Some of the inputs to improvement opportunities are:

  • Risk-Based Thinking requires an organization to take actions to mitigate risks or enhance opportunities. Both of these lead to certain actions which improve the organizational systems.

  • Non-Conforming product or processes, whenever encountered, requires you to identify root causes and take corrective actions. This could lead to making changes or process improvements to your QMS to ensure that nonconformities do not occur again. More details on this are given in the next section.

  • Future needs of the customers can indicate a lot of areas where you can expand and grow your business.

  • Customer feedback analysis and data evaluation against the goals can also point you to a number of process improvements. Measurements and review of achievement against targets are means for revision of various processes and setting of revised goals and targets for the next cycle.

Nonconformity and Corrective Action

Sub-clause 10.2 calls out requirements on how an organization should act when nonconformity is identified. Let’s define a few terms before we move forward:

  • Nonconformity - non-fulfilment of a requirement

  • Root cause analysis - a technique used to determine the underlying cause of a nonconformity.

  • Corrective action - action to eliminate the cause of nonconformity and to prevent a recurrence

When we talk about non-conformity, there are can be many potential sources of non-conformities. These include but is not limited to:

  • Internal and External Audit Findings

  • Results of monitoring and measurements, for example inspection reports, testing defects, etc.

  • Customer complaints

  • Non-compliance with regulatory and statutory requirements

  • Warranty claims

  • Problems reported with external suppliers, For example, delivery issues or incoming inspection results

  • Suggestions or problems identified by employees, etc.

When a non-conformity is encountered in a system, an organization needs to take the following steps:

  • Take action as necessary to control and correct the nonconformity, and to deal with any resultant consequences (Correction)

  • Conduct root cause analysis to identify the root cause of the problem, using appropriate problem-solving tools like 5-why, fishbone, failure mode, Pareto analysis, etc. It is not necessary that you adopt all or any of these methodologies to conduct a root cause analysis, but these methodologies give a structure to your root cause analysis and helps you identify appropriate root cause. We will see in an example below.

    • Take action to eliminate the root cause (corrective action)

    • Ensure timely closure of all corrective action

    • Conduct follow-up reviews to ensure that the action taken has been effective to eliminate the non-conformity and preventing recurrence

    • If evidence of recurrence is found, then perhaps the action or root cause identified is inadequate or incorrect. Conduct root causes analysis again to identify the additional cause and take actions against them.

    • Make corrective action records available for customers and present a summary of corrective action results for management review.

    • Also, consider if any new actions to address risks and opportunities have been identified and if so assess them in accordance with Clause 6.1.

Let’s now explore with an example how when encountered with a non-conformity, what an ideal process should be and how by effectively using tools like 5-Why, you can eliminate the non-conformity and ensure that it never recurs. To explain the approach, let’s take an example of a Fast-Food Restaurant which promises burritos delivery to home within 30 minutes of the order. The restaurant received a complaint from one of their regular customers, Ms. Olivia. She was quite unhappy with the restaurant and raised her concerns to the Restaurant Manager. The Restaurant Manager called all his team members and used 5-why to understand the root cause of the customer complaint and identify a solution. Let’s see how it went:

  • Why was Ms. Olivia unhappy with the delivery?

    • Because Burritos were delivered late

  • Why were Burritos delivered late?

    • Her address was incorrect in the software used for orders

  • Why was her address incorrect in our records?

    • Customer address changed and it was not confirmed while taking the order

  • Why was the address not confirmed while the order was taken?

    • The person taking the order missed verifying the address

  • Why did the person miss to confirm the address?

    • The software (used for taking orders) uses the default address in the system and places the order in the system. It does not require any verification of address.

The Restaurant Manager identified the below action to improve the process:
“Software used for taking orders shall have a step to verify the address and should give an indication to the person taking the order to confirm the address. Only after he verifies in the software, the order should be placed in the tool. This way the step would not be missed.”

This action is a full-proof solution to the problem. This will ensure that anyone who works with the software does not miss the step. The non-conformance will never occur again due to this reason. Observe how a small non-conformance of late delivery can lead to a huge process improvement that involved updating the software.

Again, it is not necessary that you will be able to implement corrective action for all non-conformities. For a small restaurant, getting the software updated may involve a huge cost. You need to evaluate the significance of nonconformities on the basis of their impact on operating costs, cost of correction or corrective action, impact on customer satisfaction or any other risks. Based on all these factors, an organization may decide if corrective action is required for the non-conformity or not. In a case where such corrective actions cannot be taken, the organization may reduce the likelihood of non-conformity to an acceptable level. In the example above, if spending a huge amount on getting the software updated is not feasible, you may opt for other methods like training the staff, creating a checklist, and pasting it at the desk of staff taking orders as a constant reminder, etc. This will definitely reduce the non-conformity to an acceptable level even if it is not eliminated from the system.

Continual Improvement

Clause 10.3 requires the organization to work continually to improve its QMS in terms of its suitability, adequacy and effectiveness.

As part of the continual improvement process, the organization is specifically required to use the outputs from analysis and evaluation (see sub-clause 9.1.3) and from management review (see clause 9.3) to determine areas of underperformance and to identify any opportunities for improvement.

Tools and methodologies should be employed as appropriate by the organization to investigate the cause of underperformance and identify actions to support continual improvement. At the time of Management Reviews, where effectiveness of various parameters is reviewed, is an excellent time to identify process improvement opportunities.

Continual Improvement is at the core of ISO 9001 and a key area with which all organizations shall comply with. This is the way businesses can constantly improve and maintain an edge over their competitors.

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