Nonconformance Management

Reduce Cost of Quality (CoQ) and prevent product recalls with an automated, data-driven nonconformance process.

Ensure your teams get to the root cause of every nonconformance or unplanned deviation whether on the shop floor, the laboratory or in the office.

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Whatever the source, the CQ Nonconformance Management Solution ensures your teams are capturing, triaging, investigating and closing nonconformances quickly and effectively so you can reduce the cost of poor quality.

Identifying and managing product and process nonconformance and eliminating its cause is critical to an organization’s quality system. This is especially pertinent in the stringent FDA and ISO compliant environments, where a non-conforming product, material, or component could lead to costly rework, or worse, a product recall. Our primary goal, in addition to reducing CoQ, is to capture and act on a nonconformance before it leaves the organization and reaches a customer.

- Poor quality can happen at any stage of the product lifecycle, from engineering to production, and this will have direct impact on the cost of quality. Additional costs can be incurred from any of the following: loss of time and costs associated with analyzing nonconforming goods or services to determine the root causes; retesting products after reworking on them; scrapping defective products and incurring additional costs to replace them; and even escalation to a CAPA. With a collaborative approach to nonconformance management, you can prevent any variance to process, parts, or equipment and ensure an adaptable workflow for shop floor workers to align to the ever-changing quality parameters.
- ComplianceQuest’s Nonconformance Management Solution uses Einstein Predictive Analytics to capture nonconformance trends and draw insights from data. It helps with spotting key risks, escalate to a CAPA ahead of time and also drive continuous improvement (CI) of the entire quality management process. Insights drawn from data help with identifying recurring errors, patterns of issues, the stage of production at which the error originates frequently, the process variation that is causing the error and so on. CQ’s Nonconformance Management Solution automates the process of finding a permanent and effective solution, with agility and nimbleness.
- An unwanted recall can erode brand image and lead to revenue losses. By identifying a nonconformance before it leaves the proverbial four walls of the company, you can reduce the overall cost of quality, prevent a potential injury for the end user, avoid unnecessary penalties/fines and protect brand image. Having an end-to-end automated EQMS can ensure that any quality issues are identified before dispatch and addressed in a timely manner before it reaches a customer.
- Improve customer delight by ensuring the quality of your products, with robust process control to reduce quality gaps and conform to product specifications. Even minor variations can cause customer dissatisfaction and allow the customer to start looking for alternatives. Minimize variability of materials, waste, and rework to reduce lead times and increase production yield. With an integrated, enterprise-wide quality management system, gain visibility into quality processes across the entire lifecycle to increase customer satisfaction.
- FDA’s 21 CFR 820.90(a) defines nonconformity as any nonfulfillment of specifications that applies to both products and processes and provides specific guidelines to different industries. It requires manufacturers to establish and maintain procedures to control product that does not meet the specified requirements by identifying, documenting, evaluating, segregating, and dispositioning the nonconforming product. According to ISO 9001, nonconformity can occur at any level in an organization, quality control and manufacturing to personnel procedures and categorizes them as minor and major issues. CQ’s EQMS automates ISO and FDA compliance, using a risk-based approach to prioritize nonconformances and initiate corrections to meet the specifications. This can improve customer satisfaction, boost employee morale as well as reduce cost of quality. Most importantly, CQ’s EQMS has a pre-built environment to make it efficient for quality leaders to design quality workflows for ISO and FDA compliance.
- Nonconformance due to internal failures can lead to delay in product delivery, rejection of product, rework, spiraling operational costs and regulatory noncompliance. With CQ’s NC Solution you can catch NCs on time and identify the failure mode with the help of AI to prevent recurrence as well as continuously improve your processes. CQ’s Nonconformance Management Solution, with an integrated risk assessment, automates nonconformance management workflows to identify, document and prevent nonconformances, with a specific focus on high-risk nonconformances. It also enables periodic training of employees to reduce human errors and initiate root cause analysis with advanced investigation tools such as the 5-Why collaborative whiteboard for the critical issues.

Support Your Entire Organization

Management

Get visibility across NCRs in real-time to quickly identify systemic issues, reduce cost, and prevent recurrence.
Quality

Improve process control to reduce quality gaps, lead time, increase production yield and prevent a nonconforming product reaching the marketplace.
Manufacturing

Enable teams to quickly capture, triage, find root cause, and take any remedial steps to effectively prevent waste, rework, and delays.
Engineering

Quickly access necessary nonconformance data to perform investigation and risk assessment to eliminate root cause(s).
Operations

Easy retrieval of information to reduce review cycle time and for data-driven decisions to authorize disposition of nonconforming material.
Supplier

Gain visibility, improve collaboration and minimize lag times for supplier corrective actions.

What They Say About Us

“We have rolled-out ComplianceQuest 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. CQ configuration team and support have worked hard to ensure that our needs continue to be met. They consistently go above and beyond. We cannot be more pleased with our use of CQ QMS capabilities and would definitely recommend to anyone who is looking for a modern cloud based EQMS solution especially if you want a scalable EQMS solution. ”

Solution Consultant,

Leading Auto Components Company
We have been working closely with ComplianceQuest for over a year now, and what impresses me the most, is their professionalism and patience and how much they really care that we are successful. I would have given 10 stars but there were only five. We have developed some out of the box functionality with our incoming inspection process, and the ComplianceQuest team listened very carefully to our requirements, and provided insightful recommendations. We were easily able to customize the look and feel of the interface which made it user friendly for our inspectors. The support team always make themselves available and I certainly appreciated all the quick 10 minute online meetings ‘just to make sure’ everything was okay. Thank you to ComplianceQuest for making this a fun project and I look forward to working closely with Gova and Nikki and their team as we introduce non-conformance, SCAR, Production Part Approval Process, Deviations, Audit, and Supplier Portal into our system.

Alastair Henderson,

Project Manager

Key Features of CQ Nonconformance Management Solution

CAPA Escalation

Escalate to CAPA if required based on failure mode and have key data automatically carried over to the CAPA record.
Failure Modes and Risk Conclusions

Determine Failure modes for NCs and establish risk conclusions to guide investigations and decision making.
Collaboration

Reach out to others across the enterprise and in the supply chain to solicit feedback without having to give up ownership of the tasks.
Mobile Access

Complete access to the QHSE solution including reports, approvals, record views, reviews, alerts etc., on your mobile for business continuity.
Reporting and Analytics

Utilize pre-developed best practice-based reports and create additional reports and dashboards to suit your requirements.
Social Like & Follow

Like and follow relevant records in the system and be notified via email, dashboard, and mobile to stay abreast of developments.
Identification

Streamline recording and management of all types of events from single or multiple sites in one centralized system.
Documentation

Simple, easy-to-use user interface to document allows instances of nonconformance from one or multiple sites.
Evaluation

Comprehensive triaging, risk assessment and documentation of results to provide direction for the required resolution.
Containment

Enforce containment activities to control and prevent improper usage of nonconforming material.
Disposition

Employees from one or multiple sites and divisions can collaborate to propose different disposition types and hold virtual material review boards.
5 WHY Root Cause Analysis

Perform root cause analysis, document the outcome in detail and submit for CAPA evaluation. 5 WHY Root Cause Analysis provides functionality to document numerous root causes, attach evidence and capture decisions as needed for the investigation.

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