Corrective and Preventative Action consideration

Introduction

The Quality Management System (QMS) is a document created to provide a framework for the management of a business. A QMS provides a system for setting out the purpose and direction of a business, establishing policies and procedures to achieve this aim, identifying risks and opportunities, planning for change, tracking progress towards achieving its objectives and evaluating performance against these targets.

Non-conformance

Non-conformity is an event that occurs at any time during the life cycle of a product or service that does not conform to the quality management system and/or applicable regulatory requirements.

Corrective action is defined as actions taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation.

Some more points to cover in this section are:

·      What is preventative action? Preventative action means taking steps before a problem occurs so it can be detected earlier, its causes reduced and eliminated, so that only minimal corrective action is required after detecting it has occurred in order for improvement to occur quickly.

Corrective and preventative action

Corrective and preventative action is a way of taking control of your business by doing something to change the status quo. It can be as simple as making a change in your marketing efforts or it could be more complex like restructuring or reworking your entire organization.

Depending on what you're trying to accomplish, corrective and preventative action may take place over a period of time or all at once. The goal with either strategy is always the same: improve performance so that it's better than ever before!

Problem statement

The problem statement is the first place you should look for your corrective and preventative actions. It should be short, succinct, and written in plain language. This section of your report should include:

·      What happened?

·      How did it happen?

·      Why did it happen?

Containment action

Containment action is a short-term solution to a problem. This can include cleaning up the spill or removing the source, such as an overflowing toilet or overflowing sink.

Containment action is not a long-term solution to a problem. It should be used only when there are no other options available and all immediate needs have been met by other methods of correction and prevention.

Root cause

This can be completed using multiple processes can be found online. For example 5-whys and the fishbone analysis to confirm what is the cause of the problem NOT THE SYMPTOM.

Action plan

An action plan is the process for fixing a problem. It contains the steps you need to take and how long it will take, as well as any resources that are needed to complete your project. You should also consider what cost is involved in fixing your issue (both monetary and time).

Change, training, implementation and verification of effectiveness

·      Change

·      Training

·      Implementation, verification or evaluation of effectiveness.

When something goes wrong as a result of not following the QMS you have to follow a process.

When something goes wrong as a result of not following the QMS you have to follow a process. This is called corrective and preventative action (CAPA).

The process includes:

·      Identifying the problem and its cause

·      Analyzing the situation to determine what needs to be done next, including defining responsibilities and accountability for each step in order to avoid duplication of effort between departments or teams within an organization.

Conclusion

The process for solving problems is very important. It is not enough to follow the QMS and hope that everything will be fine. You must take proper actions to fix the root cause when observations go go wrong in order for your company to remain compliant and follow best practice.