Non Conformance Report Là Gì

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

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Nonconformance occurs when a hàng hóa, 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 lớn supply a part with the specifications of length 5 centimet ± 10 milimet. 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-sản phẩm, which in turn can endanger the health và safety of your customers. In addition, you will have sầu to lớn giảm giá with remediation costs, loss of reputation, và monetary damages.

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

In this article, you will learn:

What is Non-Conformance?

Non-conformances (NC) occur when a process, service, or sản phẩm fails to lớn meet regulations & 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, & lives of end-users are also put on the line.

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

A manufacturing glitch results in a reduction of the performance unique 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 lớn the lives and safety of patients, it is governed by rigorous national & international guidelines, including FDA 21 CFR Part 8trăng tròn and the ISO guideline – ISO 13485:2016. If the organization were to lớn fail to comply with these regulations, it will result in indemnity costs, loss of character, and pecuniary damages.

FDA 21 CFR Part 8đôi mươi.90 lists out the expectations of the US FDA for non-conforming products. When a non-conformance occurs, the medical devices company is expected lớn vày the following:

Control the non-conforming productĐánh Giá and disposition of the said productReworking policies and procedures

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

Accept the necessities and responses for reworkPlan and document the rework activitiesReview & approve sầu the sameDocumentPersize the reworkValidate the results of the rework và re-inspect

There are two types of non-conformances – minor non-conformances and major non-conformances. The organization needs khổng lồ look at the frequency, detection, & impact of the non-conformance và 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, và 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 lớn detect, and has a harmful effect on the end-user, it is a major non-conformance. For example, multiple unsanctioned alterations khổng lồ 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


What Is a Non-Conformance Report?

A non-conformance report (NCR) will address the non-conformance. The primary ayên ổn of the NCR is lớn highlight the problem that has occurred (namely the non-conformance) logically and concisely. Using the NCR, the organization’s management will be able to lớn implement suitable corrections. Thus, the purpose of the NCR is khổng lồ explain the deviation of a specific process, protocol, or hàng hóa 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 NCRWhat is lớn be done to lớn prsự kiện the problem from recurringExplanation of corrective action to lớn be takenKey players involved

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


When lớn 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 processAn instrument used for a special demo in the manufacturing process is constantly malfunctioningThe raw materials used for preparing a medication are interchangedVials of vaccines are found to be contaminatedA hàng hóa is returned lớn the manufacturer with defectsA batch of products fail to meet specifications during the inspectionA vendor has supplied the wrong componentsProducts are being delivered late khổng lồ 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 lớn the notice of the management, the organization’s efficiency & productivity will improve sầu.

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.

Reason for the Non-Conformance Report: The NCR will give general details of the non-conformance. Identify the person who found the issue & important dates towards closure.Details of the Non-Conformance: Factual evidence to describe the non-conformance, its location, how it affects the functioning, & the ways & means lớn 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 prsự kiện recurrences of such non-conformances in the future.Disposition: Here, details are given about what lớn bởi with a non-conforming sản phẩm or process. In the case of a product, disposition action will indicate that the hàng hóa can be released, repaired, & reworked, or even scraped.Corrective Actions: Details of the corrective sầu actions taken & whether they were successful in solving the problem.Preventive Actions: Details of preventive sầu 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 sầu created for your organization is a retrospective document. As soon as you have sầu identified a non-conformance, the document must be started with.

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

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1. Ensure That the Non-Conformance Is Controlled

This step is taken as soon as a non-conforming process or sản phẩm 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 hàng hóa is placed in a ‘Quality Control Hold’ & is made accessible only to lớn the Quality Control (QC) team.

When the hàng hóa (or process) is properly controlled, the personnel in charge will have sufficient time khổng lồ assess the non-conformance & take suitable actions.

In this case, Quality Management Software would be highly useful as it enables users lớn traông xã 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, users can utilize pre-configured forms for documenting nonconformance events. Such forms simplify comtháng processes and help users handle nonconformance-related activities more efficiently.

3. Đánh Giá the Non-Conformance

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

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

4. Have a Plan of Action

You need khổng lồ decide on the disposition action lớn 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 lớn a previously identified problem, then a separate investigation is not required.

In general, there are five sầu 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, & it must be returned.Use-as-It-Is: This is applicable if there is only a superficial defect in the kết thúc sản phẩm, 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 và made acceptable for its intended use.

5. Persize 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. Persize a Corrective Action

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

On the other hvà, major non-conformances may need a CAPA investigation. The Corrective Action & Preventive sầu Action (CAPA) are a mix of actions that are regularly used in the life sciences industry khổng lồ eradicate non-conformances. CAPA is put into lớn action when the non-conformance is highly critical, complex, ambiguous, or systemic.

With Quality Management Software you can easily liên kết NCR’s to CAPAs và 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 khổng lồ address the non-conformance are effective.

Here a digital tool like the Nonconformance Management solution by could be very useful. allows you to traông chồng everyone’s progress towards their due dates và quickly escalate overdue tasks. With automated hiệu quả chiến lược 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 sầu that your organization effectively manages non-conformances. A lot of work thought processes, & staff time will go inkhổng lồ this process. So, you may be lured into lớn preparing a barely adequate non-conformance report. You will thua thảm 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 correctionsResponsibilityKeep trackUse an SOPhường to lớn detail how the NCR should be usedRegular reviews

Leveraging Digital Non-Conformance Management Tools

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

How will you go about doing this?

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

The Nonconformance Management Software complies with all necessary regulatory guidelines including ISO 9001:năm ngoái, ISO 13485:2016, và FDA 21 CFR Part 820.

The allows for unified tracking of non-conformances và traceability with regards to lớn 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.


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 sầu lớn take immediate remedial action and prepare a non-conformance report khổng lồ ensure that this does not occur.

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