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What is Non-Conformance Software?

Anmol Pandit on February 16, 2023

What is non conformance management system

What if a food processing plant finds that the packaging of one of its products was contaminated with bacteria during production? Or, the pharma company finds that the manufactured drug batches have the wrong dosage prescribed.

In situation like these, the possible consequences that might come across the manufacturers will be – re-work on the product, scrapping out the wrong ones, time & resource wastage and many a times wrong word of mouth for the brands which could also lead to unsatisfied customers and legal penalties.

Long story short, inability to determine non-conformance is the whole-sole reason manufacturers face situations like these. Keep on reading the blog to explore what it is and how manufacturers can prevent themselves from sliding into situations like these.

What is Non-Conformance?

Non-conformance is an indication that a service, process, product, or even the system has went wrong because it didn’t meet a specified set of requirements. A non-conformance indicates that a company’s standard operating procedures perhaps need to be modified or updated in some ways, or both. These deviations can be identified by conducting internal and external audits, analyzing customer complaints, material inspection or routine testing.

After that, a non-conformance report is created. A Non-Conformance Report provides structured documentation of the specifics of a Non-Conformance found. As a result, entities, initiatives, or individuals that fall short of the required standards in terms of quality and safety may be held liable.

This report’s objective is to record the specifics of a departure from expectations. This report assists management in providing a clear and logical definition of the issue so that appropriate steps can be taken to accomplish the desired improvements.

A non-conformance management software ensures that each non-conformance is accurately recorded and addressed with. It helps businesses in upholding quality standards and fostering growth. The module can function independently or in conjunction with our other quality control software.

What Are the Different Types of Non-Conformances?

Basically, there are two categories of non-conformance:

Minor Non-Conformance

Minor non-conformance arises on a small level and doesn’t affect the whole company. Therefore, this kind of nonconformance has small repercussions and is much simpler to resolve. For example, small fixes in product manuals. This can easily be fixed by updating the relevant documentation.

A minor non-conformance is typically not a big deal and is easy to fix. Minor non-conformances could, however, grow bigger if they are neglected. Businesses should have systems and processes in place for recognizing and resolving non-conformances in order to prevent minor issues from developing into serious ones. Some more examples of non-conformance are:

Multiple violations of requirements.
Multiple missing/unsigned documents
Improper machine calibration

Major Non-Conformance

The entire production or workflow of the company is significantly impacted by a major non-conformance. The end product could be significantly degraded by serious non-conformance issues. Things like untested items or making unauthorized, unapproved changes to the production without documenting, monitoring and communicating the impact of changes are examples of serious non-conformance.

A major non-conformance can have a significant negative impact on a company’s or organization’s reputation and brand. These are more challenging, expensive, and time-consuming to fix than a minor non-conformance. Therefore, tools and processes that are effective in identifying and resolving serious non-conformances before they have a negative impact on their operations are essential.

What consequences does non-conformance have?

If non-conformances are not identified and handled on time, they can create chaos and havoc. For example, failing to address a change to all the concerned departments may lead to incorrect functioning of your employees and thus processes going haphazard. The morale of your organization can suffer as a result of persistent personnel actions that violate ISO 9001 criteria.

Additionally, manufacturing goods that don’t meet criteria can invite rework, scraping, even product recalls, legal suits and what all follows this is obvious. But these consequences can be possibly reduced with the help of a Non-Conformance Management Software.

Non-conformance management as per ISO 9001 standard

The management of these events can be connected to any of the current ISO standards, with ISO 9001 being one of the most popular. In order to constantly enhance operations, improve the quality of output, foster efficiency and competitiveness, and increase customer satisfaction, numerous industrial enterprises have embraced the globally recognized ISO 9001:2015 quality management system.

Failure to adhere to the technical specifications of the products (characteristics, materials, operation, etc.) or of the processes results in the majority of non-conformances within an ISO 9001 management system (delays in delivery times, errors in quantities, human failure due to lack of training, inadequate use of equipment, etc.).

Tips for mitigating non-conformance

It is crucial to set up suitable procedures and vital measures intended to stop Non-Conformance before it occurs. To do this, there are a number of actions to followed:

Finding the non-conformance

A non-conformance can be found by any organization’s stakeholder, including customers, internal employees, suppliers, external auditors, and public administration. This must be disclosed as quickly as possible, whether it occurs via internal or external audits, quality controls, or analysis of consumer complaints or claims.

It is crucial to accurately describe the non-conformance during this initial stage of the process and to provide information, such as the proof that the non-conformance occurred, the document outlining what should have been done but wasn’t, the time and individual who discovered the non-conformance, etc.

Resolution of the non-conformance

Once the non-conformance has been identified and thoroughly documented, it must be fixed in order to quickly resolve the issues and the reason that caused it. The work is not finished yet; as it might not be a one-time issue and is can spring-up often; thus, it will be important to address the core cause.

Detection and investigation of the non-conformance’s root causes

In order to prevent future replication of the non-conformance, this is a crucial step. There are various effective approaches, such as the problem analysis and resolution tool, for identifying and treating the root cause (there may be one or more than one).

Planning and implementing corrective measures to eliminate the issue

Once the underlying reason of the non-conformance is identified, businesses can take one or more corrective measures to mitigate it, take charge of implementing those measures and decide a timeline for doing so.

Verification of the corrective action

The effectiveness of the corrective activities put in place will be determined in this final stage, which is one of the most crucial ones. Check that the deviation no longer occurs as soon as a circumstance identical to the one that caused the non-conformance surfaces.

Remember to solve the problem until you can confirm with absolute certainty that the remedial measure is working.

How to tackle Non-Conformance?

Implementing a Non-Conformance Software or a QMS system integrated with NC module can help you track non-conformances, identify the core issues and speed up the process of implementing the corrective actions in the business operations.

With QualityMaster NC/CAPA modules, businesses can obtain real-time data to detect non-conformances at the earliest and minimize their potential impact. In addition, they can have detailed information and tools for root cause analysis of the non-conformance and take corrective and preventive solution to eradicate it and never let the issue occur again.

With this solution, companies increase the agility with which they make decisions and execute corrective actions; experience improved competitiveness and customer service levels; reduce non-quality costs, and comply with the company’s continuous improvement strategy.

Want to make Non-Conformance Management easier, faster, and more structured?
Deploy QualityMaster now!! For more details, visit https://www.bmqualitymaster.com/contact-us/ or mail at: contact@bmqualitymaster.com

What is the Difference between a QMS, EQMS, and an EDMS?

Anmol Pandit on January 18, 2023

With Quality getting paramount importance everywhere, process manufacturing is no different. Terms like Quality Management System (QMS), Electronic Quality Management System (EQMS), and electronic Document Management System (EDMS) are gaining traction in board rooms, business meetings and on Google Search too. If you have been a part of such discussions, or have overheard or are wishing to know what these terms actually mean and function, then you are at the right place This blog elaborates their meanings, purpose and the distinguishing characteristics of them all for a better understanding. Continue reading-

What is a QMS?

A quality management system (QMS) is a formalized system that documents/describes the workflows, procedures, and responsibilities for achieving a company’s quality policies and objectives, the international standard specifying requirements for quality management systems is ISO 9001:2015 and it is one of the most widely used and prominent approach to quality management systems.

A QMS manages and coordinates an organization’s actions in order to conform to consumer and regulatory standards.

Also read: Different Types of Quality Management Systems

Who needs QMS Software?

In industries such as aviation, automotive, pharmaceuticals, food, and medical devices, where ensuring quality and safety is critical, the implementation of robust quality management systems (QMS) holds paramount importance.

For companies operating in these sectors, compliance with specific standards and regulations governing quality management is mandatory to legally sell their products.

Government agencies require these industries to adhere to stringent quality management system standards to ensure adherence to safety protocols and regulatory requirements.

Traditional Paper-based QMS Software –

Managing documents through traditional paper-based methods has become outdated. The process demands considerable effort, time, and resources to keep data updated, often requiring workers to meticulously handle data entry tasks. Yet, despite their best efforts, there’s always a chance of missing something or making errors.

Manual file management is integral to various operations such as onboarding, record-keeping, investigations, and both internal and external audits. Even minor errors in the data can lead to significant miscalculations. Hence, there’s an urgent need to transition to an electronic data storage system.

This transition aims to minimize errors, boost productivity, and allocate resources towards tasks that significantly contribute to the overall efficiency.

What is eQMS Software?

A modernized approach to quality management systems is the electronic quality management system (eQMS). It revolutionizes the management and documentation of organizational-wide business processes like product development, quality assurance, and compliance, eliminating the need for manual paperwork.

The cloud-based version of eQMS operates on cloud servers and is accessible only by authorized users from any location and at any time. Essentially, eQMS encompasses all the components present in QMS solutions but with the added advantage of centralized accessibility and enhanced security.

eQMS has demonstrated superior performance over traditional QMS software due to the ease, efficiency, and flexibility it provides compared to conventional quality management systems.

Difference between QMS system and eQMS system

What is EDMS Software?

An electronic document management system, or EDMS system, is a digital platform designed to manage various types of documents, whether they’re related to the Quality Management System, product development, HR, legal, or other categories. This system is versatile and can store different file formats like Microsoft Word, PDFs, 3D drawings, and more.

Traditionally, employees spent a considerable amount of time searching for and organizing documents manually, impacting their productivity in core tasks.

The transition from paper-based documentation to Electronic Document Management Systems has revolutionized accessibility, making documents available on smartphones or tablets.

EDMS solution isn’t limited to text documents; it accommodates various file types like images, videos, and audio files. It offers a unified view of all documents and incorporates features for printing, scanning, and storage.

A key advantage of an efficient EDMS software is its ability to automate document-related workflows, integrating seamlessly with other software such as ERP, QMS, or CRM systems. This connectivity streamlines processes and enhances overall operational efficiency.

This is how EDMS helps in building Quality Management –

To create a digital Quality management system, you can migrate all of your current quality documentation onto an EDMS, which is a cloud-based platform. It can benefit you with –

Controlled document lifecycle: An EDMS streamlines document classification, organization, and archiving from creation to archival, enhancing searchability and indexing accuracy.
Tailored workflows: Tailored for quality specialists, an EDMS offers pre-defined processes while allowing customization to suit unique operations, unlike an eQMS.
Change and design control: Flexible adjustments to quality processes with comprehensive record-keeping for all modifications.
Document review alerts: Ensures timely completion of review and approval cycles, maintaining the flow of documents within the system.
Version control and audit trails: Automatically generates audit trails, displaying version histories, changes, and approvals for document transparency.
Integration with e-signatures: Compliance-driven e-signature functionality (e.g., FDA 21 CFR part 11) to authorize documentations as per regulations.
Enhanced SOPs and compliance records: Robust search and navigation features in an EDMS facilitate compliance inquiries, offering flexibility in SOP management while serving as a unified data source.

Difference between QMS, EQMS, and EDMS

While QMS solutions aim to meet quality procedures, they have grown obsolete and traditional; in contrast, eQMS has all the features built in accordance with technological advancements and rapidly shifting compliance standards. The line of distinction between these two names is extremely thin.

However, we may conclude that eQMS is a more contemporary and effective version of QMS solutions. The eQMS seeks to automate quality management operations, maintain compliance, monitor product quality, identify non-conformance, and conduct audit activities while reducing costs & time to market by keeping all of the important company information in a centralized repository.

When it comes to EDMS, it differs slightly from eQMS and QMS. The area that this solution covers completely is the documentation and its lifecycle from creation to storage, however, EDMS is also a part of handling quality and eQMS.

QMS, EQMS, or EDMS, which one do you need?

Choosing the right solutions out of these three depends on the type of need your business operations have. The choice becomes clear only when you know what your business requirements are, what your strategy is, and which solution fits the best within your business ecosystem.

Venn diagram of QMS, EQMS and EDMS Systems

You can prefer an eQMS system as it is a complete solution serving the needs of a QMS and an EDMS. It outdoes the traditional paper-based quality management systems in ways uncountable and is quickly becoming the new standard for quality management across businesses operating in various industries and of different sizes.

If you’re also looking for an eQMS that can take your quality management process to the next level and instills a culture of Quality, QualityMaster is the right solution for you. Contact our experts for details.

What is Electronic Quality Management System (eQMS Software)?

Anmol Pandit on July 27, 2022

Overview
What is Electronic Quality Management System?
Difference between QMS and eQMS
Develop a Culture of Quality
What are the Features of an Electronic Quality Management System?
What are the Benefits of Electronic Quality Management Software?
Final Thoughts

Overview

Historically, paper-based and spreadsheet-centric quality systems were used to monitor and analyze quality-related data. Manual data entries and disconnected files made it difficult to track and manage quality-related information. Regarding challenges, while addressing top-quality management objectives for life sciences industry, respondent results were:

Quality management software (eQMS Software)

All thanks to the evolution of integrated IT-based systems like eQMS that made it easier to record and report quality variables across various access points. This blog discusses the definition, functions, benefits, and future of eQMS software with respect to total quality management.

What is Electronic Quality Management System?

An Electronic Quality Management System (eQMS) is a software solution designed to electronically handle, document, and manage quality-related processes within an organization. Its primary objective is to ensure that products meet required standards, are free from defects, and operate within defined tolerances.

This software encompasses a range of techniques, structures, processes, and resources necessary for efficient Total Quality Management (TQM) practices. By leveraging an eQMS, organizations aim to enhance process efficiency and minimize human error.

One of its key advantages lies in its ability to proactively identify potential quality issues before they manifest. It grants enhanced visibility into Quality Assurance (QA) and Quality Control (QC) processes within a manufacturing organization.

Core functionalities of an eQMS include compliance management, change management, investigation of adverse events, initiating corrective and preventive actions, managing risks, and integrating complaint management into the quality process.

The system operates as a closed-loop, ensuring accountability at every level of the quality management process.

eQMS software can be implemented through various deployment models such as on-premise, cloud-based, or hybrid setups. This flexibility allows organizations to choose based on their data access requirements.

Furthermore, these systems often offer integration capabilities with other business management software such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Product Lifecycle Management (PLM), and Manufacturing Execution Systems (MES) to streamline operations across different departments and processes within the organization.

Difference between QMS and eQMS

The difference between a Quality Management System (QMS) and an Electronic Quality Management System (eQMS) lies primarily in their operational modes, capabilities, and efficiency in managing quality-related processes:

Operational Approach:

QMS: Traditionally, QMS may rely on manual processes, spreadsheets, or paper-based documentation to manage quality-related operations. These methods can work independently, potentially leading to discrepancies and various versions of information.
eQMS: eQMS integrates all quality management functions into a single, unified software system. It stores and manages all quality-related data in a centralized location, offering a single source of truth and reducing the risk of version discrepancies.

Data Accessibility and Security:

QMS: Paper-based or spreadsheet-centric QMS can limit access to updated documents and lack a comprehensive record of changes.
eQMS: Ensures access to updated, authorized documents, and maintains an audit trail of all changes. Unauthorized or unsigned documents are flagged, enhancing data security and compliance.

Regulatory Compliance:

QMS: Managing regulatory compliance can be challenging with traditional QMS, potentially leading to compliance issues due to manual processes and inadequate documentation.
eQMS: Provides convenience and ease in handling regulatory compliance documentation by offering features specifically designed to manage compliance requirements effectively.

Develop a Culture of Quality…

“55% of respondents who don’t own enterprise quality management software (eQMS) say their quality metrics aren’t properly measured.”- LNS Report

The effective utilization of an Enterprise Quality Management Software (eQMS) is pivotal in fostering a pervasive culture of quality within an organization. When every individual within the company embraces a quality-centric approach and resources are aligned to deliver superior products, it reinforces a culture committed to excellence.

Specifically designed to optimize various quality-related aspects in manufacturing, eQMS software ensures streamlined maintenance of factory equipment, meticulous inspection of raw materials and finished goods, and proficient handling of quality audits.

Successful eQMS implementation yields numerous benefits, including heightened product quality, reduced product recalls, minimized wastage, and fewer warranty claims, all contributing to improved operational efficiency.

eQMS systems offer robust data integration capabilities, consolidating quality-related information into a unified database. This integration drives continual improvement across the entire product life cycle.

Additionally, eQMS solutions are conveniently scalable, adapting seamlessly to the growing needs of the manufacturing organization. By eliminating departmental silos and establishing automated alerts for immediate attention to quality issues, eQMS promotes accountability.

Addressing the culture of quality, ISO 9001:2015 serves as the primary regulatory guideline, ensuring the adherence to specified quality standards across the organization.

eQMS software aligns with ISO 9001:2015 requirements, ensuring that processes, individuals, systems, resources, and final products meet the stipulated standards. This guideline outlines key characteristics for a company’s culture, emphasizing quality in business processes, workforce efforts, and the end product.

What are the Features of an Electronic Quality Management System?

Specific facets of total quality management require specific features to be included in the eQMS system. Below listed are the most important functions of eQMS:

Non-Conformance – It is important to identify product issues by testing for quality and eQMS helps the organization identify events of non-conformance in following the SOPs. Valid issues are considered for further actions, while invalid issues are terminated on the spot. eQMS also records all the actions taken to correct the non-conformity.

CAPA – When a non-conformance issue is identified and found to be valid, eQMS initiates the process of improvement. It specifies the corrective actions that need to be taken in terms of change in process and the preventive action required to rework/scrap the product, so that the final product quality is maintained up to the standards.

Complaint Management – The eQMS software helps manufacturing organizations establish a complaint handling process. The entire complaint management life cycle from documenting the problem, performing root cause analysis, providing timely response to the customer, and triggering internal CAPA is integrated into the eQMS system.

Change Management – When a process change is required or a CAPA issue is raised, the eQMS system manages and documents the entire change control process. It helps businesses automate the entire change management process starting from initiating change requests, impact evaluation, actual implementation, and culminating with verification and closure.

Training Management – eQMS helps organizations keep their employees updated with the latest certifications on all controlled documents in the organization. It helps manager identify training needs and keeps track of employee performance throughout the process. The eQMS software can also issue certificates on completion of the training modules.

Document Management – eQMS manages all the critical documents of the organization from creation to approval & publishing to archival. Along with updating to the latest version of the documents, eQMS also facilitates the removal of obsolete files. It can also create a master list and document map to track document changes.

Compliance Management – eQMS can help manufacturers by maintaining a clear list of compliance requirements. It automates the tracking and control of compliance-related activities like documentation, planning, reporting, audit, etc. eQMS also simplifies the reporting of non-compliance events to save the company from legislative action.

Risk Management – eQMS takes a very structured approach to identify, assess, control, communicate and review all the quality risks in the organization. With eQMS, organizations can take actions to ensure that any anticipated problems don’t occur and if they do, have a control mechanism to rectify them.

Audit Management – eQMS helps organizations conduct internal and external audits to enhance product quality. It can schedule, structure, perform and assess periodic and ad-hoc audits within the specified time frame. The audit management functionality also helps organizations meet industry-specific compliance requirements.

What are the Benefits of Electronic Quality Management Software?

An eQMS can transform the manufacturing organization in terms of men, machines, materials and methods. Below are the major benefits of an eQMS:

Enhanced Effectiveness: Clearly defining and achieving quality objectives set by the organization.
Cultivating a Quality Culture: Instilling a values-based system focused on maintaining high-quality standards across the organization.
Streamlined Data Management: Establishing a centralized database for consistent and accurate data management, ensuring a single source of truth.
Enhanced Accessibility: Enabling access to the system from multiple devices such as laptops, smartphones, and tablets.
Improved Audit Functionality: Setting tolerance levels and creating audit trails to facilitate effective audit processes.
Increased Customer Satisfaction: Adhering to quality policies and implementing streamlined processes directly impacts customer satisfaction.
Enhanced Compliance: Maintaining updated compliance records and automating alerts to ensure adherence to regulations.
Improved Documentation: Defining and documenting critical processes and objectives systematically for better clarity and understanding.

Final thoughts

eQMS focuses on the consistency of the process. It ensures that every time a production cycle is performed, the same information, material, methods, skills & controls are applied in a constant manner. Along with heightened productivity, an electronic qms software helps prevent costly mistakes, enhance product management, improve risk forecasting and establish quality metrics. Therefore, it is important for organizations to implement an eQMS and QualityMaster can prove to be a perfect choice.

Get QualityMaster today and enjoy the benefits of end-to-end quality management. Feel free to write to us at contact@bmqualitymaster.com, or contact us to know more about it as well as our other products.

What is Document Management System (DMS)?

Anmol Pandit on June 1, 2022

Do you know what all companies have in common? It doesn’t matter if it’s the IT industry, healthcare, manufacturing, automobiles, cosmetics, finance, or any other industry, they all rely heavily on documentation.

Documents are the foundation of any company. Documents play a critical part in the smooth operations and ultimate success of it.

There isn’t a single business on the planet that can get through a day without reading and sharing papers. This comprises of, among other things, marketing brochures, project proposals, technical documentation, training materials, etc.

Yep. Documents in the workplace are essential!

The difficulty is that the more documents we create and rely on for work, the more important it is to have processes in place to manage them across the organization. And, a Document Management System can be a best bet for this.

But, first thing first-

What is actually a Document Management System or DMS?

As the name implies, a Document Management System (DMS) is a system or software that makes it easier to create, store, manage, index, protect, and retrieve digital documents. Although the majority of Document Management Solutions store all of your digital documents on the cloud, they are much more. In a true sense, it is a framework that allows vital information to flow freely throughout a company.

A competent Document Management System may help you organize all of your files and data in one place, maintain track of all of your key papers, increase accuracy, and enable 24/7 access to documents from anywhere in the globe. As a result, using it allows you to stay ahead of the competition by providing all of the information your staff requires to complete their tasks effectively.

What’s more? Document Management System is totally off the charts!

Apart from helping make all of the tasks associated with document management easier, faster, and more efficient, DMS offers numerous reasons why a company should use it right away. Here are a few examples:

1. Reduced Storage Space

Any business can benefit from a software-based DMS that eliminates the need for file cabinets, boxes, and storage bins, freeing up valuable office space.

2. Enhanced Security

To protect sensitive data, document security is crucial for enterprises of all sizes. Access to sensitive information can be regulated at the folder level for different groups or individuals. In addition, a DMS keeps a track of who has viewed a document, when it was accessed, and how it was altered. Documents that are managed are highly traceable and can be labelled to trigger automated alerts.

3. Improved Regulatory Compliance

Meeting certain compliance standards manually in document management can be rather complicated. At the same time, non-compliance can result in fines, license suspension, and, in some situations, criminal liability. Sarbanes Oxley and HIPAA, for example, are federal and state regulations that require tight security and privacy guidelines. However, non-compliance is less likely with a Document Management Solutions.

4. Easier Document Retrieval

Finding and recovering papers can take a long time, and we all know that is ultimately taking money out of our pockets. The average office worker spends 30 to 40% [Source: Forbes] of their day looking for printed documents, while businesses spend $20 on labor to file a document, $120 on labor to find a misfiled document, and $220 on labor to reproduce a lost document [Source: Konica Minolta]. These excessive document management expenditures chew into a company’s budget, hinder productivity, and limit its potential for growth.

A Document Management System can be a time-saving and powerful tool. A DMS can retrieve files based on a word or phrase in a document, depending on the solution used.  It also allows users to access documents from afar. Documents can be accessed from anywhere at any time as long as there is an internet connection.

5. Better Collaboration

Acting as a central repository, an advanced Document Management System Software substantially simplifies the ability to access documents and collaborate. It gives more visibility into business processes and allows for improved workflow monitoring. 

6. Better Disaster Recovery and Backup

A data backup and disaster recovery plan are included in a well-designed Document Management Solution. Documents are protected from fire, flood, and other disasters with digital archiving as a back-up. Documents are also easily traceable and may be tracked using a variety of criteria using a DMS. Thus, it lessens the possibility of papers being misfiled or lost after they have been seen.

7. Productivity Improvements

With all the data and documents just a click away, the team can put all its efforts in just working rendering higher productivity, every single day. Staff morale and client satisfaction can both benefit from faster and more efficient document retrieval.

So, what are you waiting for? Turn over a new leaf with QualityMaster’s DMS and stop putting your files into a closet no less than a well.

QualityMaster’s Enterprise Document Management System is a feature-rich desktop and DMS that allows you to save, create, track, retrieve, and manage all types of documents. It supports the complete document lifecycle for an organization, from content generation through distribution to archiving and, finally, secure content retention and deletion.

In a nutshell, it unifies your document management requirements into a single, cost-effective system. Furthermore, it is simple to use, has a simple interface, and provides a high level of flexibility, allowing businesses of all types and sizes to use it to suit their document management needs.

As a result, Cloud-based Document Management System is getting popular in businesses that want to become paperless. Want to be in same boat? If yes, ask for a demo now!

Benefits of a Functioning Nonconformance Management System

Anmol Pandit on May 5, 2022

“You are into a business of manufacturing glass studs of size 50 mm. But an inspection revealed that a particular lot of the studs measures 45 mm.”

“A product you recently delivered to a customer didn’t match their specification, and was of a different color. More so, it was delivered to a wrong address initially. You came to know this when a customer complaint was received in this regard.”

“Crucial details such as temperature information, and the supervisor’s signature, are missing from your batch records.”

“A reduction of quality at your plant floor has been experienced due to a certain manufacturing procedure.”

What do you make of these statements?

These are all examples of nonconformance, or nonconformity, which essentially means that something has went wrong somewhere; either in a product, a service, a process, material from a supplier, or in the management system itself. It basically is an activity or a process which doesn’t fulfil its intended purpose.

A nonconformance in quality management generally occurs when something some way does not meet the specifications or requirements that could be defined either by a customer, or a regulatory body, or by an organization. It is ubiquitous, can happen anywhere, and at any time in a business, and is usually identified externally by customers, or auditors, and internally by testers or staff from other departments.

Any nonconformity or nonconformance in quality management can result in bad customer experiences, rework, product recall, and may even impact the organizations in terms of cost, reputation, productivity, and efficiency. It is important for the businesses to identify and address them in a timely manner through corrective actions and preventive actions (CAPA).

Non-Conformance In Terms of ISO

The international standard that highlights the requirements for a quality management system (QMS), ISO 9001 ensures that a business organization consistently offers quality products and operates appropriately under its regulatory measures. And if it doesn’t operate up to the set standards, it’s called non-conformance.

ISO 9001 defines nonconformance in quality management as the failure to meet one or more of the existing requirements. When an organization goes outside the regulatory boundaries, it must control and fix the problem before continuing business. Failure to do so may lead to the company’s downfall, as these standards mean everyone needs to play by the same rules.

Satisfying their customer base is one of the biggest objectives of organizations, and the ISO 9001 standards have been put in place to ensure that this objective is met, along with the other objectives such as quality and safety for the employees as well as the customers, high employee morale, etc. If not for these standards, the organizations wouldn’t be held responsible for their business practices and actions.

Nonconformance Management System- The Secret to Efficiently Managing Non-conformances

No wonder, managing the nonconformances is of great significance for business organizations; especially the ones that put great value on quality of their products, services, and processes. For all such organizations, nonconformance management is a very handy quality tool which can quickly determine systemic issues within the business.

Nonconformance management is fundamentally the process whereby the business organizations manage nonconformances in a way that they are promptly identified, properly documented, thoroughly investigated, and appropriately segregated and dispositioned on the basis of applicable regulations and standards.

And for effective as well as efficient nonconformance management, organizations rely on a nonconformance management software. The investment made in a nonconformance management system is a massive decision, and can potentially make or break an organization. That’s why the businesses need to invest in the right software, which can offer a number of benefits.

Here’s What a Functioning Nonconformance Management System Can Offer

Nonconformance in quality management requires a robust tool that provides features and support to identify and manage product conformance. The features mentioned here include the steps required to recognize and resolve the nonconformance issues from all sources, including identification, remedial action, root cause determination, CAPA, etc.

A functioning nonconformance management system allows users to:

Identify and register any nonconforming materials, and keep a track of them.
Set processes, due dates, escalations, and even notifications to ensure the materials are managed quickly and in a timely way.
Link deviations to any nonconformance records, and initiate corrective actions.
Create a history of risk within a product, process, supplier, or production line.
Close the loop on nonconformances by initiating change management, so that improvements can be made organization-wide, and risk of recurrence could be mitigated.

Investing in the right nonconformance management system has immense benefits for the businesses. Check out the benefits of an effective, and functioning nonconformance management software:

It helps businesses streamline their conformance processes
It allows businesses Identify any materials that don’t conform, and also the areas that require action
It helps avoid the risks of escalated nonconformance costs, including the internal/external failure costs, regulatory fines, etc., and also in terms of reputation and resources
It improves quality processes by facilitating efficient use of resources
It allows businesses to easily see where their procedures aren’t working as planned, thus giving them an opportunity to address this and improve the effectiveness of their system
It provides the businesses with an opportunity to drive continual improvement by consistently addressing their nonconformity.
It brings down the quality costs substantially
It facilitates stronger collaboration and a better risk response

To sum up

Nonconformances, as we mentioned above, are ubiquitous. In addition, they are inevitable, and can adversely affect the businesses in more ways than one. It is essential for businesses to identify and address them in the most effective as well as timely manner. For the same, they turn to a nonconformance management software.

A functioning nonconformance management system could be a standalone solution, or a part of a QMS software. Regardless of how it comes into the system, it should address risks and allow the internal/external stakeholders to browse reminders, conformance notifications, and the escalated issues related to quality.

It makes sense for businesses to invest in a fit-for-purpose nonconformance management system that delivers these benefits. If your existing system is not good enough, it would be prudent to explore other options such as QualityMaster, a best-in-class QMS with a potent nonconformance management functionality, to quickly see these benefits. Write to us for more information, or to schedule a demo.

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