Corrective Action Process

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What is a corrective action process?


In this post, we’ll be taking a look at the corrective action process. We’ll cover what it is, some examples, why your business should use one, what’s good about it, and some things you might want to watch out for.

Let’s start with the basics, a corrective action process is where a business takes a series of steps to prevent recurrence of a process failure or non-compliance. When designed as an effective closed-loop system, the corrective action process is a powerful tool for driving improvement.

An effective Corrective Action Process should be should one of the critical controls within a company’s Quality Management system and is often a key area of focus during times of audit. With an effective system implemented, data is presented to the business, highlighting required process improvements thus forming a critical part of your business improvement processes.

What is a corrective action process?

A corrective action process focuses on capturing, investigating, and irradicating process failures or non-conformance. It has various attributes which include: 

  • It assesses emerging non-conformances, targeting the root cause and placing long term rectifications in place to prevent a recurrence
  • It helps improve capabilities to meet requirements consistently (be they client-based or regulatory). 
  • It utilizes conformity data, which is captured and assessed throughout the organization.
  • To be effective, it needs to be integrated into existing business processes
  • It is not a fire and forget process and requires an element of audit to prove its effectiveness.

Example corrective action

Let’s look at a simple example to put the process into context;

“Machining company ABC Inc has made 100 parts for Aerospace company XYZ Inc. On receipt, XYZ has observed non-conformances. XYZ Inc rejects the parts back to ABC Inc for further investigation.”

“Machining Company ABC, Log the rejection, halt manufacture of outstanding orders, and review existing work in progress.

 A cross-functional team is then assembled to review/confirm the non-conformance and determine the root cause.” 

“Following detailed investigation, the root cause is determined to have been a machining program error. The error is corrected, Inspection plans updated, and a trial set of parts is produced, which proves conforming to requirement.

Information is passed to XYZ Inc; rejected stock is reworked to design, and manufacture of future orders is resumed with the corrected program.”

As you can see from this example, this is a repeat problem that had gone unnoticed; the error needs to be logged, investigated, and remedied with the process requiring input from throughout the business.

The need for a corrective action process

As you can see from our simple example above, without a corrective action process, a business:

  • Would fail to highlight issues where required standards have not been met
  • Would lack a basic process for the review of non-conformance
  • Would lack a structured process to remedy the issue
  • Would lack validation processes to confirm the issue had been successfully addressed
  • Would face an unacceptable level of risk
  • Would see communication around such issues ineffective
  • Would fail in utilizing data for continuous improvement.

All of these things ultimately impact the ability to satisfy the customer and for the organization to be effective.

Corrective Action Process Flow

To be effective, a corrective action process has a number of pre-requisites, which include:

  • Responsibilities for steps within the process are clear
  • The process should manage relationships between stakeholders
  • Monitoring should take place ensuring the system is meeting requirements (easy status reporting)
  • The process should rely on accurate data

While each business may tailor their corrective action process specifically to their business systems, a typical process resembles the following:

1/ Identify the non-conformance

2/ Log a corrective action

  • Define the problem statement

3/ Set a priority level by:

  • Identifying the risk of recurrence
  • Calculating the impact of the non-conformance

4/ Respond to event

  • Establish a team
  • Define the problem, the actual impact may focus on a number of elements including some of the following
    • Impact to customer
    • Safety
    • Cost
    • Reliability
    • Determine if an immediate response is required (i.e in event of safety concern)

5/ Undertake a Root cause analysis

  • Use of tools like:
    • 5 Why
    • 8d
    • Fish-bone
    • Brainstorming
    • Utilize data

6/ Determine a solution

  • Determine possible solutions
  • Use data to help derive possible solutions and their likely effectiveness 
  • Use experiments to prove solution effectiveness
  • Gain consensus

7/ Implement a solution

  • Update documents
  • Undertake Training
  • Deploy information to stakeholders

8/ Validate the effectiveness of the solution

  • Plan to follow up and validate solution effectiveness (where issues exist feed back to step 1)

Designing a corrective action process

If you’re setting out designing a corrective action process, it’s vital to consider upfront what your goals are and how you can simplify the process.

In designing corrective action processes, many organizations adopt tools like the Plan-Do-Check-Act sequence (PDCA) to provide the backbone of their process.  

Many businesses find they have parts of the solution, the typical problem, however, is the lack of a closed-loop system.

When developing a corrective action process, a deployment plan may look similar to the following: 

Step 1: Plan

  • What are you trying to achieve through implementing a Corrective action process?
  • What is the standard that has to be met?
  • Is the requirement documented and agreed?
  • What are the likely inputs into the process (e.g audit findings, inspection failures, customer complaints, supplier non-conformances) and how will these be captured and fed into the process?
  • How will you prioritize issues?
  • How will you agree on solutions before them being deployed, are there authorisation routes that must be followed? 
  • How will you monitor the effectiveness of a solution?

Step 2 Do:

  • Create the corrective action system by following the data and requirements from Step 1
  • Document processes and policies
  • Document/highlight areas of individual responsibilities
  • Deploy KPI’s
  • Train users
  • Implement the system

Step 3 Check

  • Follow some corrective actions entered into the system to validate that the system works as planned

Step 4 Act

  • Update process as required based on feedback from stage 3, retrain users as required

How continuous improvement strategy benefits from an effective corrective action process.

An effective Corrective action process can feed directly into your business’s continuous improvement ideology. We discussed the PDCA (Plan Do Check Act) cycle earlier in this post. In a continuous improvement context, the corrective action process sits firmly within the Check stage.

Utilizing data captured from its corrective action system, a business can continuously analyze the effectiveness of its business systems, determining where change is required.  

Where a closed-loop system has been implemented, this continuous cycle of improvement can drive change enabling the organization to drive performance.

Typical Problems with Corrective action process

While outwardly simple, implementing an effective process can be challenging. It requires resources and careful planning in order to be effective.

Many of the problems typically encountered are based around how simple a process has been deployed. 

An effective process sees information flowing seamlessly within the organization and brings disparate groups together to focus on improvement. A cumbersome process (usually one that has not been automated) can lead to deterioration in use and reduced (or nil) effectiveness.

Typical challenges include:

  • System is time-conuming and unwieldy. Users are “put off” and Corrective actions are not followed up
  • Data used to support the system is poor leading to poor conclusions and ineffective change.
  • Records/documentation are incomplete or not easy to access
  • Corrections/changes to issues are not verified/followed up
  • Root cause identification is poor
  • Training for users is ineffective

Summary

Given the requirements of the process, trying to meet the needs in a large organization can be challenging (if not impossible with a manual system).

Teams looking to deploy an effective process should prioritize reducing the strain on potential users high up in the requirements review. Given the importance of the corrective action process, it’s not a surprise that numerous businesses look to automate it.

An automated system has several advantages by:

  • Facilitating compliance
  • Establishing data that can further enhance continuous improvement capability.
  • Provides a standard tool across the organization

In leveraging method and resources then combining with accurate data a systemized corrective action process can be a key enabler for business excellence. An automated closed-loop system to drive quality, increase transparency, drive effectiveness and achievement of standards should be high on the list of must-do for any business.