Quality Improvement: Nonconformity and Corrective Action

Nonconformity

Nonconformity and Corrective Action In Projects

When an issue is discovered with either a work process or process output, it may result in a nonconformity or nonconformance report (often referred to as an ‘NCR’).  Nonconformity and nonconformance are essentially the same thing.  The NCR process results in a fix for the immediate issue and a related fix that reduces the likelihood that the issue will recur. 

This blog looks at what an NCR is and the generic quality process for analyzing and addressing it.  It also briefly looks at quality processes like the NCR but more suited to some of the situations that come up.

Nonconformity Report

Procedures are the same as processes, it’s just that are written down.  A nonconformity occurs when either:

  1. A process is not being followed – regardless of the outcome in terms of the output.  The issue here is that what is being done is not aligned with what is expected to be done.  These NCRs are generally the result of Quality Assurance (QA) audits and activities.
  2. A work output does not meet requirements – at least one specific property does not meet established minimum requirements.  The issue here is that there is a gap between what was expected and what was delivered.  These NCRs are generally the result of Quality Control (QC) identification of repeated failures in outputs.

Corrective Action Plan

Corrective actions are part of the nonconformity process although they are often considered a separate process.  The reason they are sometimes considered a separate process is that different teams may handle them.  In some cases, the Corrective Action Plan (CAP) process exists to ‘game’ key performance indicator measures by closing the NCR quickly and opening a CAP to show quick closure of NCRs while performing the slower work under the CAP process.  Although the issue remains until all corrective actions are in place, the NCR metrics look better.

Resolving Nonconformities

Following a sound process provides the best ‘assurance’ that the quality of the output will meet requirements.  Work process NCRs must be addressed because the assurance that process outputs will meet requirements is lost when they are not followed.  Addressing process NCRs involves either having those involved follow the process, modifying the process because what is being done is an improvement or some combination of the two. 

When outputs do not meet established minimum requirements, it indicates that there is an issue within the process.  Either the process is not being followed or it is not capable of consistently generating an acceptable output.  The cause of the nonconformity must be investigated.  Either the people using the process must follow the process, the process must be modified, or, if the issue is equipment or materials related, an expanded investigation is required to identify possible failing processes in other areas.

Generic Nonconformity Resolution Process

When an NCR is issued, it indicates that a process is seriously unreliable (broken).  In some quality systems, alternate quality processes that are like the NCR but do not involve the same level of rigor can also be used.  The NCR and other processes typically involve:

  • Reporting and determining the validity of a potential nonconformity,
  • Assessing risk caused by the nonconformity (the risk will influence the level of effort involved in the remainder of the process),
  • Developing a thorough understanding of the issue and its causes (there is rarely a single cause),
  • Resolving any immediate problems associated with the issue and verifying that the resolutions are implemented and effective,
  • Taking steps to ensure the likelihood of the issue occurring again is reduced and verifying that the resolutions are implemented and effective,
  • Summarizing these steps in a report and obtaining signoff on the report from the process owner and other relevant management personnel.

The NCR Process as Part Of Continual Improvement

Continual improvement is the ongoing improvement of work processes so that acceptable process results are achieved more consistently and efficiently.  NCRs are used by QA and QC to support continual improvement by analyzing issues and permanently resolving them through improvement to the relevant processes.  By reducing the likelihood of issues through improved processes, the costs associated with waste and rework are lowered, and profitability increases. 

Alternate Processes for Quality Remedies

In some organizations, an NCR is reserved for a complete process failure and other options are available to address process and output issues.  For example:

  • Potential Deficiency Report (PDR) – used in some construction projects when a construction issue is discovered, and it appears to be a one-time event.  If it is a repeating issue, an NCR is raised.
  • Preventive Action Request (PAR) – used in some quality management systems when potential issues with a process or output are identified but the process does not appear to be broken.  If an investigation shows the problem to be more serious, an NCR is raised.
  • Opportunity For Improvement (OFI) – used to document continual improvement suggestions when there is no specific issue identified.  Often used to transfer knowledge from an auditor to an auditee.

An example illustrating the difference is: an NCR is issued when a train goes over a washed-out bridge and ends up in the river, a PAR is when someone is warning the engineer that the bridge is out, and an OFI is when a bright young person suggests putting a light up two miles from the bridge to warn that it is out.  A PDR is when someone notices a rail that is missing a couple of spikes.

Why is risk involved in the NCR process? 

Not all NCRs have the same implications for production or the project.  Those with a significant impact need to be identified and prioritized over those with minimal impact.

Is a CAP a valid process? 

It is, provided CAP statistics are part of the key performance indicator reporting as well as NCR statistics.

What systems use more than simple NCR/CAP reporting? 

In smaller organizations, it may not be appropriate to use a selection of quality processes for nonconformities.  In larger organizations and projects, NCRs may be reserved for major issues, and less involved processes used to resolve minor issues.

Can an NCR be issued when the output meets requirements? 

Yes – if the output is sound but the procedure is not being followed, the NCR process should consider aligning the procedure with current practice.

Why does the process owner need to sign off on NCR and similar quality processes? 

The process owner must be aware of all issues and recommendations related to their processes.

Conclusion

The NCR process is sometimes split into NCR and CAP processes.  They are initiated by both QA and QC.  All NCRs should go through a risk assessment to prioritize them.  When QA auditors identify an issue, they can issue NCRs as an alternative to keeping the audit open until all the findings are addressed.  When QC inspectors identify an issue, they may initiate an NCR.  Alternatives to the NCR process that may be relevant to each organization’s quality system should be considered for larger organizations.

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