Non-conformance (or nonconformity/nonconformance) means that something went wrong with a process, service, or product, and the result does not match the initial specifications.
For example, if your company (medical devices/pharmaceutical/biotechnology) does not have scientifically sound controls in place, there is no assurance that the testing protocols, drug products, drug product containers, raw materials, or labeling will conform to the required standards of purity, identity, strength, and quality. You may end up adding the wrong drug concentrations, mixing the wrong drugs, or insufficient concentrations of a given drug. All these are non-conformances.
In this article, you will learn:
- What is Non-Conformance?
- What Are the Different Types of Non-Conformances?
- How Are Non-Conformances Identified?
- How Are Non-Conformances Addressed?
- How to Prevent or Minimize Non-Conformances?
- Importance of Digital Tools Like Non-Conformance Management Software
- Frequently Asked Questions About Non-Conformances
What is Non-Conformance?
Non-conformances, NC for short, result when a product, service, or process falls short of industry-defined regulations and standards. Because of non-conformances, organizations are impacted adversely in terms of their reputation, costs, effectiveness, and efficiency. Let us look at some examples in the context of the life sciences industry to understand non-conformances.
- Because of a manufacturing glitch, a batch of 15mL syringes on inspection is shown to hold only 14.9mL of liquid.
- Because of faulty testing equipment, the purity of a drug is compromised.
- Evidence for the training of employees in an assembly work instruction is not captured.
The life sciences industry is governed by stringent industry regulations because they have a huge responsibility for the lives of patients. Non-compliance can endanger the health and safety of patients. In addition, a failure to comply will lead to remediation costs, huge monetary damages, and a loss to the company’s reputation. Such issues can be identified during routine inspection or testing, internal and external audits, or through end-user complaints.
Let us now look at some of the international standards that are dedicated to quality management systems (QMS). QMS is a collection of the resources, assets, processes, and cultural values whose aim is organizational efficiency and customer satisfaction.
- ISO 9001:2015: ISO is the “International Organization for Standardization”. It is an NGO located in Geneva, Switzerland, whose cause is the development of voluntary standards for the maintenance of product safety and quality. ISO 9001:2015 provides the framework for quality improvement. Any organization that provides services and products (such as the pharma industry) can adopt this standard and, thus, match customers’ requirements and expectations very efficiently.
- ISO 13485:2016: This ISO standard emphasizes the requirements for a QMS for the design and development of medical devices and related services to regulatory standards.
- FDA 21 CFR Part 820: Under the US Food and Drug Administration (FDA) regulations, all device manufacturers who distribute commercial medical devices in the United States of America must have FDA 21 CFR Part 820 compliance. This document outlines Current Good Manufacturing Practice (cGMP) regulations and is also called quality system regulation (QSR).
What Are the Different Types of Non-Conformances?
Internal auditors generally classify non-conformances as minor or major. But it should be noted that this is not a requirement as per the above-mentioned quality standards.
There are two types of non-conformances- minor non-conformance and major-non-conformance. The difference is how many corrective measures you need to put in to get your organization back on course.
Two points need to be noted irrespective of the type of non-conformance.
- Address the non-conformance straightaway
- Minor non-conformances can become major non-conformances. So, don’t brush off minor problems under the carpet!
An effective way of finding out if a non-conformance is minor or major is to look at its frequency, detection, and impact.
- Will the problem be often repeated?
- Will the system detect the problem on time?
- What is the impact of the problem is not corrected?
A minor non-conformance is one that seldom occurs, is detected without any difficulty, and does not impact your customers directly.
Examples of minor non-conformances include:
- A single missing/unsigned document
- Any unauthorized alteration to a document
- Release of a purchase order without prior approval
- Using an instrument after its calibration date
A major non-conformance recurs, is difficult to detect, and has a negative impact on your customers if it is not corrected.
Examples of major non-conformances include:
- Multiple missing/unsigned documents
- Multiple unauthorized alterations to documents
- Multiple violations of requirements
- Problems that adversely affect processes or operations
How Are Non-Conformances Identified?
Non-conformances can be recognized via internal and external audits, routine testing, an inspection of products and protocols, and negative customer feedback.
Once a non-conformance has been identified, a nonconformance report (NCR) is prepared to address the problem.
How Are Non-Conformances Addressed?
Non-conformances are typically addressed by an NCR. The chief aim of the NCR is to define the problem clearly, concisely, and logically. This will help the organization’s management to implement appropriate changes.
The Corrective Action and Preventive Action (CAPA) is a set of actions that aim to improve the organization’s processes and protocols by eradicating non-conformances. Such CAPAs are routinely used in life sciences industries, including medical devices, biotechnology, pharmaceutical, biologics, food & beverages, amongst others.
The CAPA process has a series of steps that need to be effectively completed. Each action that is taken is carefully documented for continuous quality improvement. The proper execution of CAPAs is needed as per ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR 820 QMS.
Let us look at how non-conformances can be addressed in the life sciences industry. You observe that during the manufacturing process, a particular component is not functioning properly. You choose to get the component replaced by the supplier.
However, the problem arises again, and you initiate a CAPA to find out the root cause. You find that the component is made of the wrong type of alloy and is not good enough for your purpose. You go on to discuss with the supplier the specifications of the component and ensure that they supply the correct components.
In this example, a digital tool like CAPA Management Software by SimplerQMS would be very useful. It provides an out-of-the-box, closed-loop CAPA process, that is integrated with other quality management system processes, where everything is stored in a centralized location. Such a system allows you to identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) with ease and connect these to NC’s, audit findings, etc. This allows you to get a better overview and status of your CAPA’s and issues.
How to Prevent or Minimize Non-Conformances?
Let us look at another example of a non-conformance and how it can be prevented/minimized.
In your medical devices company, the internal audit team has found that a finished product is defective, and is not up to industry standards, i.e., it is non-conforming. For instance, a catheter that should fit within a 5 French Guide during the procedure does not fit properly. This is a major non-conformance that will considerably affect its functioning.
All organizations will have to deal with non-conformances at one time or another. It becomes essential to have an effective process in place to deal with non-conformances. It should be emphasized that a thorough management review, review with the concerned employees, conducting an internal audit, documentation and implementation, feedback, and a focus on constantly improving one’s standards are all prerequisites.
The most important components in this process are:
- Immediate corrective action
- Root cause analysis
- Long term corrective action
- Validating the effectiveness of the approach
You should quickly respond to the non-conformance. This could be done by alerting the customer, or separating an item, or reviewing a protocol straightaway.
Immediate Corrective Action
Here, you will plan out the steps needed to bring back the process or product into conformance.
You will assign responsibilities, timescales, and demonstrable proofs for each of the tasks.
Root Cause Analysis
The root cause analysis answers the question ‘How did the non-conformance occur in the first place?’ This step is crucial. Unless you identify the reason(s) for the non-conformance, long-term solutions cannot be achieved. The root cause analysis must be factual with all questions getting answered.
Long Term Corrective Action
Do not go into this step until you have fully identified the root cause for the non-conformance.
Similar to the immediate corrective action step, in this step, you will assign responsibilities, timescales, methodologies used, and demonstrable proofs.
Validating Effectiveness of the Approach
The entire approach is proved effective if the non-conformance does not get repeated. Use this last step to review all records and documents used in the previous steps.
Let us revisit the example cited at the beginning of this section and see the process for minimizing/preventing this from occurring again.
- Containment: Quarantine the products from the given batch with a unique ‘HOLD’ label and shift them to a pre-defined holding area under the supervision of quality assurance.
- Immediate corrective action: Allot responsible personnel to check whether one or more batches of the product are non-conforming. Also, whether any of these defective products have been dispatched. If so, these products need to be brought back from the customer as quickly as possible.
- Root cause analysis: Ask the Quality Assurance (QA) department to evaluate the non-conformance and raise an NCR detailing the reasons for the non-conformance.
- Long-term corrective action: Constitute a technical team to thoroughly investigate the causes for the finished product’s non-conformance. Based on the findings of the investigation, decide whether the product can be re-graded or rejected. Since this is a major non-conformance, the entire batch of products must be rejected.
- Validating effectiveness: Recheck the entire process. The products are checked thoroughly over a specified period. If the non-conformance is not repeated, it indicates that the corrective action has worked.
Importance of Digital Tools Like Non-Conformance Management Software
In this age and day, organizations need to have a non-conformance management solution that is innovative, upgradable, and flexible. Such a solution should be able to match your organization’s needs and ensure compliance with industry standards, product safety, and quality. Such solutions include digital tools like non-conformance management software.
The SimplerQMS Non-Conformance Management Software complies with ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 820 QMS standards.
The software allows for seamless tracking of the current state of non-conformance(s), traceability of components, equipment, suppliers, and CAPAs. Using the software you can identify, analyze, and manage NCs with ease.
Additionally, the software automatically generates post-market surveillance reports allowing you to easily gain an overview of NC-trending.
Frequently Asked Questions About Non-Conformances
A non-conformance report documents non-conformances in an organization. Non-conformances result when something goes wrong with a process, service, or product, and the result does not match the initial specifications.
The purpose of a non-conformance report is to define the problem (i.e., the non-conformance) in clear, concise, and logical terms. This will help the organization to rectify the problem and implement appropriate changes.
The non-conformance process has 5 important components. They are containment of the problem, immediate corrective action, root cause analysis, long-term corrective action, and validation of the effectiveness of the entire process.
When a non-conformance occurs, you deal with it by first reviewing it with the management and then the employees concerned, conducting an internal audit, documenting, and implementing the non-conformance process, followed by feedback. The focus is to constantly improve the organization’s standards.
When a process, service, or product does not match initial specifications, it results in non-compliance. Non-compliances can endanger the health and safety of patients. The life sciences industry (medical technology/pharmaceutical/medical devices/biotechnology) has a huge responsibility in this regard. Additionally, a failure to detect and rectify such problems will lead to remediation costs, monetary damages, and loss of reputation. Such non-compliances need to be detected, analyzed, and set right at the earliest.
Non-conformance management software help assist everyone in the life sciences industry in the common goal of greater quality that complies with ISO 9001:2015, FDA 21 CFR Part 820, and ISO 13485:2016 QMS standards. Such software will allow seamless tracking of the non-conformance and the traceability of components, equipment, suppliers, and CAPAs.