Man inspecting batch of pills for an Out of Specification (OOS) investigation in a factory

OOS – OUT OF SPECIFICATION

Investigate OOS and document results and initiate actions with integrated workflows

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Out-of-Specification (OOS) refers to results or conditions that do not meet the established specifications or acceptance criteria for a product, process or system. It is an important aspect of quality management because it helps organizations identify and address issues that could impact the quality of their products or services. TrackWise Digital can be leveraged to document the different investigational steps needed for compliant OOS management and how the different components interconnect to facilitate CAPA and follow up.

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Why is Managing OOS important?

Effectively managing OOS instances is crucial in quality management, involving the handling of results or conditions deviating from established specifications or acceptance criteria for a product, process, or system. This process is integral to the commitment to quality, serving as a mechanism for promptly detecting and addressing deviations that could compromise the integrity and reliability of products or services.

SUPPORTS EFFECTIVE QUALITY MANAGEMENT

SATISFIES REGULATORY COMPLIANCE

BUILDS TRUST WITH CUSTOMERS

CULTIVATES CONTINUOUS IMPROVEMENT

A woman in personal protective gear inspecting a batch of pills on a conveyer belt for an Out of Specification (OOS) investigation

Identifying OOS instances acts as an early warning system, enabling organizations to pinpoint anomalies and irregularities impacting overall quality standards.

By actively monitoring and managing OOS occurrences, companies can engage in root cause analysis, understanding the factors contributing to the deviations. This understanding facilitates the implementation of targeted corrective and preventive actions, preventing the recurrence of similar issues.

Two people in business suits shaking hands

Systematic OOS management is imperative for adhering to regulatory standards and industry requirements. Compliance with established specifications ensures not only product quality but also meets legal and regulatory obligations. Timely and accurate documentation of OOS instances is essential for regulatory reporting and demonstrating a commitment to maintaining high standards. Failure to manage OOS instances effectively can result in regulatory sanctions, product recalls, and damage to the organization’s reputation.

A woman in a pharmacy holding a tablet facing the camera

Beyond regulatory compliance, managing OOS instances extends to customer satisfaction and brand reputation. Consumers expect consistency and reliability in the products and services they purchase. Instances of OOS can erode customer trust and satisfaction, leading to negative repercussions for the brand.

A proactive and transparent approach to managing OOS safeguards against potential quality issues and reinforces the organization’s dedication to delivering products or services of consistent quality.

A man next to production machinery using a tablet to investigate OOS tracking while on site

Efficient management of out-of-specification instances is crucial in quality management, serving as a tool for maintaining high standards, ensuring regulatory compliance, and safeguarding brand integrity.

A proactive stance towards OOS instances positions organizations to rectify immediate concerns and cultivate a culture of continuous improvement, contributing to sustained success in the competitive marketplace.

What are the Risks of Poor OOS Management?

The risks associated with poor OOS management can include:

RELEASE OF PRODUCTS OR SERVICES THAT ARE SUBPAR OR NOT UP TO COMPANY STANDARDS

INCREASED COSTS DUE TO THE NEED TO REWORK OR REPLACE DEFECTIVE MATERIALS OR PRODUCTS

POTENTIAL FOR NONCOMPLIANCE WITH INDUSTRY REGULATIONS AND STANDARDS

Worker in personal protective equipment using a microscope to investigate a batch out of specification

OOS Complexities

As a quality manager in a regulated industry, managing out of specification results is a critical aspect of maintaining regulatory compliance and ensuring product quality and safety. An out of specification (OOS) result is any analytical result that falls outside of predefined specifications or acceptance criteria.

Managing OOS results effectively can be a complex and challenging process, particularly if OOS results are frequent or complex. As a quality manager, you may face various business problems that make it difficult to manage OOS results effectively. For example, you may struggle with identifying and investigating OOS results, determining the root cause, and implementing corrective and preventive actions.

Implementing OOS management software can help you address these challenges. By centralizing and automating the OOS management process, software solutions can improve efficiency, reduce errors, and streamline workflows. OOS management software can also provide real-time visibility into OOS status, progress, and results, making it easier for quality managers to track progress and ensure compliance.

For example, a quality manager in the pharmaceutical industry may be struggling to manage OOS results related to drug potency or impurity levels. OOS management software could help them streamline the process, ensure that all OOS results are adequately documented, investigated, and resolved, and track the implementation of corrective and preventive actions to reduce the likelihood of similar OOS results occurring in the future.

Similarly, a quality manager in the environmental industry may use OOS management software to manage OOS results related to water or air quality testing, ensuring that all OOS results are appropriately documented, investigated, and resolved, and that the implementation of corrective and preventive actions is adequately tracked and verified. By implementing OOS management software, quality managers can improve compliance, reduce the risk of errors, and demonstrate their organization’s commitment to quality and safety.

Benefits of Using OOS Technology

Quality management systems (QMSs) can help organizations manage OOS by providing tools and functionality to identify and report OOS results or conditions, investigate root causes, implement corrective and preventive actions and monitor the effectiveness of those actions. A QMS can also provide visibility into the status of OOS activities, enabling organizations to make informed, data-driven decisions to reduce risk and improve quality.

Man walking through a hall of large tanks checking OOS tracking records while on site using a tablet

Enhanced Efficiency and Productivity

OOS management software can help automate many of the time-consuming tasks associated with OOS investigations, such as data collection, trending, and reporting. This can help reduce the time and effort required for these tasks.

A man in a lab coat digitally tracking an OOS investigation on a tablet while next to a batch of tubes

Improved Accuracy and Consistency

By automating the OOS investigation process, the risk of human error can be significantly reduced. This can help ensure that investigations are thorough and accurate, and that findings and conclusions are consistent across different investigations.

Three workers in lab coats collaborating on an Out of Specification (OOS) investigation on a table.

Better Collaboration and Communication

OOS management software can help improve collaboration and communication between different departments and stakeholders involved in the OOS investigation process. This can help ensure that everyone is on the same page, and that any issues or concerns are addressed in a timely and effective manner.

Two man smiling sharing OOS tracking on a laptop at a desk

Regulatory Compliance

OOS investigations are a critical component of quality control and are subject to regulatory requirements. OOS management software can help ensure that investigations are conducted in compliance with these regulations, and that all required documentation and reporting is completed accurately and on time.

Hands with rubber gloves using a tablet in a pharmaceutical production facility

Data-Driven Decision Making

OOS management software can help facilitate data-driven decision making by providing real-time data and analytics on OOS events. This can help quality managers identify trends and patterns as well as make informed decisions to improve quality control processes and prevent future OOS events.

Three people in business suits meeting to discuss audits in a lobby

Improved Auditability

OOS management software can help ensure that all investigations are documented and auditable, providing a complete and transparent record of the investigation process. This can help demonstrate compliance with regulatory requirements, as well as provide a valuable resource for future reference and analysis.

A man siting at a desk testing a pharmaceutical batch for specifications

Overall, using OOS management software can bring significant benefits to quality managers and their organizations, including enhanced efficiency, accuracy, and compliance, as well as better decision making and collaboration. While the initial investment and disruption may be significant, the long-term benefits are well worth it.