ISO 9001:2015 in Clause 10, “Improvement” has following sub-clauses that refer to continuous improvement system that should be embedded in the system while going for ISO 9001 certification or re-certification process. These clauses are:
10.2 Non-conformity and Corrective actions
10.3 Continual Improvement
The Difference Between Correction and Corrective ISO 9001 Actions for Improvement:
With ISO 9001 actions for improvement there is a very minor line that distinguishes between a correction and corrective action being taken. For example if you identify a problem and made a quick fix on temporary basis so that operation chain remains undisturbed while corrective action is not just looking at the surface and doing quick fixes. Corrective action are taken on identified root cause after doing detailed Why-Why analysis.
During execution of corrective actions, ISO 9001 guidelines do not force to document each and every corrective action that has been taken to solve nitty-gritty problems.
What Is Meant By Preventive Actions?
ISO 9001 actions for improvement include preventive actions. Preventive actions is defined as those actions that are taken to eliminate the potential non-conformity’s cause that may exist in your current system and can cause potential gap or a hurdle in certification or re-certification process.
Corrective and Preventive Actions Explained In a Nutshell:
Preventive actions are those actions those actions that are taken in order to prevent occurrence of the problem whereas Corrective actions are those actions that are taken in order to eliminate the chance of recurrence of the identified problem.
The whole process of identifying problems, solving them, preventing their future occurrence and exploring opportunities for improvement is Continuous Improvement Cycle that is an integral part of ISO 9001 implementation and maintain ISO 9001 certification.
What Is Continuous Improvement Cycle?
Continuous Improvement cycle sometimes called as PDCA (Plan Do Check Act) cycle runs on following four simple steps:
1 – Plan: Before ISO 9001 process planning, first identify and understand the problem that you want to solve or minimize. Planning can be done of anything like business management meeting, workforce tasks or kicking off a project. Before going to execute any task, it is important to plan it properly. Planning can be done by breaking down one big objective into small task making a Work Breakdown Structure (WBS), setting up milestones and timelines for each task.
2- Do: The second “Do” step is all about executing the work that is planned in the previous step but preferably on small scale first so that you can refine your taken actions afterwards during execution. It is advisable to plan activities and set timelines of each task on realistic ground keeping all the constraints in mind so that all the activities can be accomplished within decided timelines. After executing the planned tasks, observe the results.
3- Check: Study the achieved results, measure how much effective were the actions that was taken in “Do” step and decide whether your decided and executed steps were good enough to achieve the target or not. If not, please go back to “Plan” to review task and timelines once again and then execute them in different way.
4- Act: If the executed actions were effective and sustainable to the desired level then pursue for implementation the best solution discovered so far.
Various number of iterations can be performed while doing PDCA cycle and that is where you will be moving forward to continuous improvement of your organization.
What Are the Ways In Which Any Organization Can Improve?
Any organization can be potentially improve with ISO 9001 Actions for Improvement in following three of the ways:
- Process Improvement: How a Product or Service is delivered to the customers?
- Product Improvement: How the product or service is designed?
- Management Practices Improvement: a management system to enable improvements.
How PDCA cycle and ISO 9001 process are connected?
The tested and tried continuous improvement activity segmented in PDCA cycle is advisable to use when:
- You need to implement or embed Total Quality Management (TQM) or Six Sigma or Quality Management System (QMS) in your current management system.
- You need one time solution for your reoccurring problem and want to test them on pilot scale to test the sustainability of the advised solution.
- You need to minimize or control waste production and to initiate some cost saving initiatives as well by eliminating the rolling out of ineffective solutions that waste your time, money and energy.
What Breakthrough Results Can Be Achieved by Continuous Improvement Cycle?
ISO 9001 process demands to have continuous improvement system to be actively embedded in the management system to maintain effectiveness of high quality standards. Top three advantages of having continuous improvement loop be embedded in your current management system are:
- Improved efficiency in employee engagement level and in meeting day to day manufacturing targets.
- Meeting and even going beyond customer’s expectations.
- Minimization of gaps between ISO 9001 standard and your current management system leading to fully compliance and ease in maintaining ISO 9001 certification.
- Waste reduction leading to cost saving and improved profit margins.
Process for ISO 9001 Corrective and Preventive Action:
The process for ISO 9001 Actions for Improvement include corrective and preventive action steps simplified below:
- Define the Problem: Identify and understand the bug. It is preferred to write a problem statement that consists of 5-W and 1-H rule.
- Define the Scope: Defining how big the problem is defining its scope. What is the problem, when it occurs, where does it occurs, why it occurs, who the problem is about and how it occurs.
- Containment Actions: Advise and perform some immediate fixes known as “Just Do” to minimize the problem for the time being.
- Finding the Root Cause: Root cause can be find out by using various problem solving methodologies. The most effective yet simple ones are Fishbone analysis and asking “Why” five times until an actual root cause is discovered.
- Planning Corrective Actions: Plan actions that should be taken to eliminate the root cause.
- Implementing the Corrective Actions: implement corrective actions on small scale that are decided in previous step.
- Reevaluate the Achieved Results: Wait some appropriate amount of time and observe if the problem reoccurs. If the problem reoccurs after implementing corrective and preventive actions, need to see actual root cause and fix it.