Nonconformance  >  Non conformance Report Software

Non conformance Report Software

non conformance report software
non conformance report software

Businesses often face many challenges in balancing customer expectations and regulatory needs. To truly ensure that the products or services meet all quality standards, businesses must periodically check for nonconformances. This process helps eliminate issues that can affect the product’s quality.


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Understanding Non conformance Report Software

ComplianceQuest’s Non conformance Report Software is a flexible, scalable, next-generation solution that aims to ensure product quality, safety, and compliance. The non conformance software streamlines all the quality processes to manage defects and process deviations and reduce cycle time, focusing on continuous improvements while meeting product quality specifications. The Non conformance software aims to reduce operational costs by minimizing product rework and recalls.

  • Improves customer satisfaction and brand loyalty by addressing non conformances, identifying root causes, and determining corrective action to prevent a recurrence.
  • Standardizes reporting to communicate non conformances efficiently within the company and provide the necessary data at the right time.
  • Improves efficiency and productivity with user-friendly data-gathering tools.
  • A closed-loop centralized system helps capture, track and document non conformance data for better organizational visibility.
  • Reduces CoQ within the organization by improving non conformance rates and resolving non conformances to reduce the risk of warranty and recall costs.
understanding of nonconformance software

Features of Nonconformance Reporting Software

CQ Nonconformance Reporting Solution helps capture, triage, investigate and disposition all nonconformances in a timely and effective manner. The nonconformance software helps create an automated, data-driven process for identifying and managing the nonconformance of both products and processes. Some of the main features of the CQ Nonconformance Report Software include the following:

nonconformance report Software features

  • Streamline all nonconformance recordings from single or multiple sites in one centralized system.
  • A simple, easy-to-use user interface allows documenting instances of nonconformance from one or multiple sites.
  • Comprehensive triaging, risk assessment and documentation of non conformance results help take the required resolution.
  • Enforce containment activities to control or prevent improper usage of nonconforming material.
  • Collaborate with employees from one or multiple sites and divisions to propose different disposition types and hold virtual material review boards.
  • Perform root cause analysis and document its outcome in detail for CAPA evaluation.
  • Evaluate every nonconformance or event against the CAPA requirements of the organization and generate CAPA where required.
  • Reach others within the enterprise and in the supply chain without compromising ownership of the tasks.
  • Use pre-built best practice-based reports or create personalized reports and dashboards based on your requirements.

Six Uses of CQ’s Nonconformance Software

  • A collaborative approach to nonconformance management can help reduce the Cost of Quality (CoQ) that may arise due to internal failures.

  • ComplianceQuest’s Non conformance Management solution uses Einstein Predictive Analytics to capture nonconformance trends, spot key risks, and draw insights from data while focusing on continuous improvement (CI) of the entire quality management process.

  • Use CQ’s Non conformance software to prevent product recalls by catching nonconformances early in the cycle, thus preventing injuries and penalties while ultimately protecting the brand image.

  • Maintain the quality of the product with robust process control to reduce quality gaps and conform to product specifications.

  • Automate non conformance management workflows using CQ’s Non conformance software to identify, document and prevent non conformances, with a specific focus on high-risk nonconformances.

  • Ensure ISO 9001 and FDA 21 CFR 820.90 compliance at all organizational levels.

Automation of Nonconformance

Robust Quality Control: How Intelligent Automation of Nonconformance, Equipment and Inspection Management Processes will Save Time and Costs

Steps to Create an Effective Nonconformance Reporting

Writing a non conformance report is a seven-step process:

nonconformance report steps

  • Non conformance can happen at any stage in the production or operation process. Identify the event and write details of it for the investigation process. Once nonconformance is identified, it leads to CAPA or even product recalls.
  • Once the nonconformance issue has been raised, a nonconformance review team steps in to determine the next actional steps. This involves segregation of nonconformances, review, and addressing of violated quality or safety standards.
  • After the nonconformance review is complete, the next step is to determine the action plan that defines the corrective measures prepared to resolve the non-conformances.
  • Before launching corrective measures, the organization should focus on and document the probable causes that led to the occurrence of nonconformance.
  • Depending on the severity of the nonconformance, it can be closed. This can be as simple as employee training, change in process cycle, or CAPA for systematic or complex concerns.
  • Once the corrections have been implemented, it is imperative to monitor their effectiveness. This step ensures that actions are appropriate and effectively eliminate nonconformances once identified.
  • Documentation is the backbone of NCR. All NCRs must be reviewed and approved, finalizing the nonconformance closure. Every finding and insight must be documented along with actionable plans.
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How to write a non conformance report?

A non conformance report is a written document that is prepared to identify and report discrepancies between the current working condition of a product, service or process and the requirements defined by quality standards within the organization. While non conformance reports are applicable to any part of the organization, it is most prepared for manufacturing, production and operations. Simply put, non conformance reports pave the way to implement CAPA.

A typical Nonconformance Report consist of:

  • Date and time of the occurrence

  • Department of Non-Conformance

  • Identification number (reference)

  • Identifier of the Non-Conformance

  • Person responsible

  • E-signature of the person completing

  • Initial analysis of the nonconformance

  • Cause of the Nonconformance

  • Date of Nonconformance

  • Location of the Nonconformity

  • Description of the Nonconformity

  • Corrective and preventive actions

  • Significant

  • Classification of minor or major

  • Date and time of the occurrence

  • Department of Non-Conformance

  • Identification number (reference)

  • Identifier of the Non-Conformance

  • Person responsible

  • E-signature of the person completing

  • Initial analysis of the nonconformance

  • Cause of the Nonconformance

  • Date of Nonconformance

  • Location of the Nonconformity

  • Description of the Nonconformity

  • Corrective and preventive actions

  • Significant

  • Classification of minor or major



Great product, support, and people to work with!

We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.

Lia Budiman,
Solution Consultant, Continental Contitech

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continental contitech logo

Quality-centric Companies Rely on CQ QMS

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Ensure quality, safety, and compliance with CQ’s Nonconformance Report Software, which is a flexible, scalable, next-generation solution that aims to ensure product quality.

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Frequently Asked Questions

  • The responsibility of creating a non conformance report is with the Quality Management team. Anyone from the team, including the quality manager or the head of quality from the team, can create a non conformance report.

    • Management can use Non conformance software to gain better visibility across NCRs in real-time to quickly identify systemic issues, minimize cost, and prevent a recurrence.

    • Quality can have a better handle on process control to reduce quality gaps and lead time, improve production yield, and prevent nonconforming products from being pushed to the customer.

    • Manufacturing teams can capture nonconformances, triage quickly, find root causes, and take remedial steps to prevent waste, rework, and delays.

    • The engineering team can leverage the Non conformance software to quickly access all the necessary nonconformance data to perform a risk assessment and eliminate the root cause(s).

    • The operations team can easily retrieve information to reduce review cycle time and implement a data-driven decision-making process to authorize the disposition of nonconforming material.

    • Suppliers can use the Nonconformance software to gain visibility, improve collaboration with internal teams, and minimize lag times to perform supplier corrective actions.

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