Nonconformance Report Illustration

What is Non-Conformance Report in Life Sciences?

by | Sep 6, 2021 | Nonconformance

A non-conformance report (also called NCR or non-conformity report) is used to document non-conformances within an organization.

Nonconformance occurs when a product, service, or process is not following the industry specifications.

As an example, the internal audit team of your life science organization has identified a non-conforming part provided by a vendor.

The vendor has to supply a part with the specifications of length 5 cm ± 10 mm. However, on incoming inspection, your audit team notes that the length of the part is 6 cm. This mismatch can adversely affect the functioning of the end-product, which in turn can endanger the health and safety of your customers. In addition, you will have to deal with remediation costs, loss of reputation, and monetary damages.

So, when a non-conformance occurs, remedial action is taken in the form of a non-conformance report.

In this article, you will learn:

What is Non-Conformance?

Non-conformances (NC) occur when a process, service, or product fails to meet regulations and standards defined for that particular industry. With continuous non-conformances, the organization’s efficiency, effectiveness, reputation, and finances can be affected adversely. Importantly, the health, safety, and lives of end-users are also put on the line.

Some examples from the life sciences industry will help us understand these non-conformances better.

  • A manufacturing glitch results in a reduction of the performance quality of a medical device.
  • The purity of a drug is compromised because one of the ingredients is impure.

Since the life sciences industry is crucial to the lives and safety of patients, it is governed by rigorous national and international guidelines, including FDA 21 CFR Part 820 and the ISO guideline – ISO 13485:2016. If the organization were to fail to comply with these regulations, it will result in indemnity costs, loss of character, and pecuniary damages.

FDA 21 CFR Part 820.90 lists out the expectations of the US FDA for non-conforming products. When a non-conformance occurs, the medical devices company is expected to do the following:

  • Control the non-conforming product
  • Review and disposition of the said product
  • Reworking policies and procedures

ISO 13485:2016-8.3.4 states that ‘rework’ is the process by which a company can eliminate a non-conformance and calibrate a process or product with its requirements. The key steps to rework are:

  • Accept the necessities and responses for rework
  • Plan and document the rework activities
  • Review and approve the same
  • Document
  • Perform the rework
  • Validate the results of the rework and re-inspect

There are two types of non-conformances – minor non-conformances and major non-conformances. The organization needs to look at the frequency, detection, and impact of the non-conformance and classify it as minor or major.

Ask yourself the following questions:

  • Will the problem get repeated?
  • Will the system detect the problem on time?
  • What is the impact in case the problem is not corrected?

If a non-conformance rarely occurs, is detected easily, and does not impact the end-user directly, it is a minor non-conformance. For example, an unsanctioned alteration to a standard operating protocol, an unsigned document, or the use of a piece of equipment past its calibration date, are considered minor non-conformances.

On the other hand, if the non-conformance recurs frequently, is difficult to detect, and has a harmful effect on the end-user, it is a major non-conformance. For example, multiple unsanctioned alterations to an SOP, numerous unsigned documents, or multiple violations, are all examples of major non-conformances.

Recommended Reading: What Is Non-Conformance And How to Minimize It

Minor Nonconformance and Major Nonconformance Illustration on a Weighting Scale

What Is a Non-Conformance Report?

A non-conformance report (NCR) will address the non-conformance. The primary aim of the NCR is to highlight the problem that has occurred (namely the non-conformance) logically and concisely. Using the NCR, the organization’s management will be able to implement suitable corrections. Thus, the purpose of the NCR is to explain the deviation of a specific process, protocol, or product from the required specifications and standards. It will also detail preventive measures for the future.

At a minimum, the NCR will include the following information:

  • What went wrong or the reason for the NCR
  • What is to be done to prevent the problem from recurring
  • Explanation of corrective action to be taken
  • Key players involved

Furthermore, Electronic Quality Management System, or eQMS for short, allows you to hyperlink NCR’s to products, components, suppliers, protocols, customers, and equipment. By linking different parts together and storing them in a single system, you will have a better overview and traceability of each nonconformance.

Downloadable Non-Conformance Report Template Banner

When to Issue a Non-Conformance Report?

The following examples from the life sciences industry can be an indication for issuing an NCR.

  • A certain component keeps breaking during the manufacturing process
  • An instrument used for a special test in the manufacturing process is constantly malfunctioning
  • The raw materials used for preparing a medication are interchanged
  • Vials of vaccines are found to be contaminated
  • A product is returned to the manufacturer with defects
  • A batch of products fail to meet specifications during the inspection
  • A vendor has supplied the wrong components
  • Products are being delivered late to customers

The above examples show that non-conformances can occur at any time, with the result that non-conformance reports need to be prepared.

Who Can Issue a Non-Conformance Report?

Any employee in a given organization can report a non-conformance.

As a matter of fact, if more issues are brought to the notice of the management, the organization’s efficiency and productivity will improve.

However, the persons responsible for issuing non-conformance reports are typically personnel in the Quality Assurance Departments, Project Managers, or Project Consultants.

Example of a Non-Conformance Report

The framework of a non-conformance report will have the following details.

Nonconformance Report Elements as an Illustration
  • Reason for the Non-Conformance Report: The NCR will give general details of the non-conformance. Identify the person who found the issue and important dates towards closure.
  • Details of the Non-Conformance: Factual evidence to describe the non-conformance, its location, how it affects the functioning, and the ways and means to rectify it.
  • Stakeholders Involved: The personnel in Quality Assurance Departments, Project Managers, or Project Consultants are the people responsible for reviewing the objective evidence of the various actions taken. They will also acknowledge that the non-conformances are closed.
  • Root Cause Analysis (RCA): The RCA may bring up process-level changes that will prevent recurrences of such non-conformances in the future.
  • Disposition: Here, details are given about what to do with a non-conforming product or process. In the case of a product, disposition action will indicate that the product can be released, repaired, and reworked, or even scraped.
  • Corrective Actions: Details of the corrective actions taken and whether they were successful in solving the problem.
  • Preventive Actions: Details of preventive actions that will ensure that such a failure does not occur again.

Tips for Writing an Effective Non-Conformance Report

The non-conformance report that you have created for your organization is a retrospective document. As soon as you have identified a non-conformance, the document must be started with.

To write an effective non-conformance report, the following tips will be useful.

1. Ensure That the Non-Conformance Is Controlled

This step is taken as soon as a non-conforming process or product has been identified. As previously stated, non-conformances can occur anytime. For example, a non-conforming product is identified just before it is transported. The product is placed in a ‘Quality Control Hold’ and is made accessible only to the Quality Control (QC) team.

When the product (or process) is properly controlled, the personnel in charge will have sufficient time to assess the non-conformance and take suitable actions.

In this case, Quality Management Software would be highly useful as it enables users to track and manage different versions of a document using the version control feature. Moreover, the software system ensures that only the right people have access to the right documents.

2. Document the Non-Conformance

This step indicates that the non-conformance is reviewed thoroughly and documented in the NCR. Responsible personnel, including the QC department, will be tasked with writing the NCR.

Furthermore, with Quality Management Software, like SimplerQMS, users can utilize pre-configured forms for documenting nonconformance events. Such forms simplify common processes and help users handle nonconformance-related activities more efficiently.

3. Review the Non-Conformance

Then, discuss and review with the person issuing the NCR the standards that were deviated from. You need to verify all details of the non-conformance and also assess the magnitude, namely whether it is a minor or major non-conformance.

With an eQMS, you can easily send the NCR through an automated workflow for authoring, review, and approval. This helps you work more efficiently and decreases the risk of errors.

4. Have a Plan of Action

You need to decide on the disposition action to correct the non-conformance. In fact, disposition may also mean not taking any action at all.

For example, if a non-conformance has resulted due to a previously identified problem, then a separate investigation is not required.

In general, there are five different disposition categories.

  • Scrap: You decide to destroy a product instead of one of the other given choices.
  • Return: This is applicable when your vendor has delivered an erroneous part or component, and it must be returned.
  • Use-as-It-Is: This is applicable if there is only a superficial defect in the end product, which will not affect its intended purpose.
  • Downgrade: You can use this disposition step if an upgraded product or process is found to be defective. In such a scenario, revert to the older version until a solution is found.
  • Rework: You can use this disposition step if the product can be reworked and made acceptable for its intended use.

5. Perform a Root Cause Analysis

When you do a root cause analysis, you are finding out the primary cause for the non-conformance. You will also determine if an inquiry is necessary.

6. Perform a Corrective Action

In the case of a minor non-conformance, minor actions that are specific to the non-conformance are sufficient. These could be re-training employees, re-fining a cosmetic error, or written work instructions.

On the other hand, major non-conformances may need a CAPA investigation. The Corrective Action and Preventive Action (CAPA) are a set of actions that are regularly used in the life sciences industry to eradicate non-conformances. CAPA is put into action when the non-conformance is highly critical, complex, ambiguous, or systemic.

With Quality Management Software you can easily link NCR’s to CAPAs and have cross-functional visibility in a single system.

But, note that if your organization is doing too many CAPAs, you have a big problem!

7. Keep Track of Effectiveness

Ensure that all actions taken to address the non-conformance are effective.

Here a digital tool like the Nonconformance Management solution by SimplerQMS could be very useful. SimplerQMS allows you to track everyone’s progress towards their due dates and quickly escalate overdue tasks. With automated KPI reports, you can get an overview of NCs, for example, see the current status of open/closed NCs.

8. How to Prepare a Great Non-Conformance Report

It is imperative that your organization effectively manages non-conformances. A lot of work thought processes, and staff time will go into this process. So, you may be lured into preparing a barely adequate non-conformance report. You will lose the opportunity of making sure that crucial improvements work.

Prepare a great non-conformance report using the following best practices:

  • Document, document, document!
  • Catalog into major or minor corrections
  • Responsibility
  • Keep track
  • Use an SOP to detail how the NCR should be used
  • Regular reviews

Leveraging Digital Non-Conformance Management Tools

As a Quality Assurance Manager, you will be aware of the fact that a pre-emptive, proactive approach is superior to a reactive, defensive approach.

How will you go about doing this?

By using a bespoke Nonconformance Management Software solution by SimplerQMS, you will identify, evaluate, and manage non-conformances efficiently and automatically. Such software will assist everyone, from the employee to the management, with the common goal of better quality.

The SimplerQMS Nonconformance Management Software complies with all necessary regulatory guidelines including ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 820.

The SimplerQMS allows for unified tracking of non-conformances and traceability with regards to CAPAs, components, suppliers, and equipment. Additionally, the software will generate automatic post-market surveillance reports, wherein the major portion of the report will showcase trends in non-conformance reports.

Nonconformance Management Software Illustration

Final Thoughts

Your Pharmaceutical company is manufacturing a COVID-19 vaccine that will be distributed across the globe. Perchance a batch of these vaccines is contaminated. Thankfully, the QC team has detected it before transportation. This is a major, critical non-conformance that needs to be sorted out immediately.

You will have to take immediate remedial action and prepare a non-conformance report to ensure that this does not occur.

By using a digital Non-conformance Management solution, you will seamlessly track the non-conformance, document, take corrective action, and ensure that this problem does not arise again.

Downloadable Non-Conformance Report Template Banner

Non-Conformance Report Template

Illustration of Non Conformance Report Template