Deviation Management

Define temporary exceptions for parts, products, processes, and engineering documents. Gather expert input, approve their use, and retain traceability through expiration.

Control Temporary Deviations from Request to Expiration

Trackmedium's eQMS Deviation Management module gives temporary departures from requirements a defined owner and a documented decision. Record the original specification and actual result, identify the affected material or document, and gather contributor input before approval. Manage the active period, record consuming products, and finish traceability after the deviation expires.

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Define the Deviation and Its Scope

Describe the original specification and the actual result. Identify affected parts or products, quantity and defect category, or the process and engineering documents involved. Add locations, notes, attachments, and related-record links.

Gather Contributor Input

Create linked Contributor Input Activities for engineering, production, quality, or other subject-matter experts. Assign a contributor, describe the input needed, and retain their response and supporting files with the deviation.

Approve with Clear Ownership

Route the deviation to its owner for approval. All contributor input activities must be completed or cancelled before approval can send the record to Active. The owner can return the record to Initiated for changes with a recorded reason.

Manage the Active Period

Set start and expiration dates and notify the electronic distribution list when approval moves the record to Active. Extend the expiration date using the Extend Deviation action, or end the active period early when the deviation is no longer needed.

Trace the Consuming Products

Record serial numbers and sales models of products that used the deviated parts, together with supporting attachments. Preserve the connection between the temporary exception and the products affected by its use.

Finish Traceability After Expiration

Move the record to Expired - Pending Product Data Entry so the owner can finish consuming-product information. Then route it to Expired to end the workflow. Configured escalations support expiration routing and assignment reminders.

From Binder-Based Deviations to Digital Control

LioChem moved Deviation and Nonconformance records from manual binders into digital workflows with tracking, approvals, and clearer status visibility.

"... previously, all our deviation and nonconformance records were kept in a binder with no updates, approvals, or visibility."

Larry Tyler, LioChem, artience Group

See the full case study

Connected Platform

Connect the deviation to its originating nonconformance, affected controlled documents, and related quality records. Module lookups and record links keep the exception in context; availability depends on the modules enabled in your system.

Nonconformance Management

Create a deviation from a nonconformance when a temporary exception is needed. Keep the parent record linked so the nonconforming condition and the decision remain connected.

Document Control

Select affected controlled documents and retain their number, revision, effective date, title, originator, and owner. The document lookup is available when Document Control is enabled.

Corrective Action Management

Use document links to reference related corrective action records when further quality work is needed. Keep the temporary exception connected to the wider investigation without losing its original context.

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Deviation Lifecycle at a Glance

Follow the deviation from Initiated through Approval and Active to Expired - Pending Product Data Entry and Expired. Gather contributor input before activation, then retain the consuming-product details needed to finish traceability.

Define the Deviation Initiated: describe the exception, scope, owner, and applicable dates.

Gather Expert Input Create contributor activities and retain the responses needed for a decision.

Approve & Activate Approval: complete or cancel contributor activities, then approve to Active.

Track Consuming Products Active: record affected serial numbers, sales models, and supporting files.

End the Active Period Move to Expired - Pending Product Data Entry to finish traceability.

Finish Data & Expire Complete product information and route to Expired to end the workflow.

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Built for Quality-Driven Industries

Trackmedium's eQMS Deviation Management module helps teams make temporary exceptions explicit across product, manufacturing, and engineering work. Retain the affected requirement, the approval decision, and the consuming-product information needed to understand how the exception was used.

Regulated Industries

Retain specifications, controlled-document revisions, contributor input, and approval records to support your organization's established quality processes.

Life Sciences
Medical Devices
Aerospace & Defense

Oil & Energy
Automotive & Industrial Manufacturing

Non-Regulated & Growth-Focused Sectors

Give temporary product and process exceptions an owner, an expiration date, and a traceable outcome so they do not become undocumented working practices.

Consumer Goods
General Manufacturing
Logistics & Supply Chain

Hardware Technology
Construction & Engineering

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Why Trackmedium eQMS?

Make Exceptions Explicit

Record what should have happened, what actually happened, and the material or documents affected. Give the approver the information needed to make a documented decision.

Give Input a Clear Owner

Assign contributor activities, retain responses, and require them to be completed or cancelled before approval. Use assignment views and reminders to follow up on outstanding work.

Retain Product Traceability

Connect the approved exception to consuming-product serial numbers and sales models. Finish traceability after the active period ends and retain the record of the deviation.

What Our Customers Are Saying

Trackmedium eQMS is proud to provide simple, globally accessible quality management solutions across all industries.

"Trackmedium team are very knowledgeable and professional, helpful and supportive with the set up and technicalities. Product easy to use, easy to navigate, prompts adequate and useful. Product makes compliance easy to achieve, especially with the e-signature capabilities and audit trail functions."

Kike I
Quality Assurance Manager

*Source: ^footnote1

"Good value for money, peace of mind, excellent customer support and professional staff members. Ease of use with Nonconformance and CAPA module linkage and Audit module linkage with unique action reference numbers."

Kike I
Quality Assurance Manager

*Source: ^{footnote

1}

"We have greatly enjoyed working with the Trackmedium team and the system has brought great advances in efficiency and compliance within our organisation. Having used and evaluated a number of other systems, Trackmedium was easily the best value. That along with the collaborative nature of Trackmedium's team means that we have learned and adapted a lot together during our implementation."

Catherine B
Head of Quality and ESG

*Source: ^{footnote

1}

"The team at TRACKMEDIUM has vast experience in Quality, Environmental, Health, Safety and more. Their expertise made it very easy for us to implement exactly what we wanted. Anytime I had a question they were very quick with a response or solution. Our organization loves this system and so do our customers and external auditors. It has allowed us to gain new business with how impressed the customers have been."

Larry T
Quality Systems Manager

*Source: ^{footnote

1}

"Great, and we would like to use Trackmedium for customer tracking as well to streamline our process."

Sherriann A
APAR Specialist

*Source: ^{footnote

1}

"Very helpful, very friendly, very responsive, fairly priced for what is provided."

Jane W
QHSE Coordinator

*Source: ^{footnote

1}

"Overall experience is great. I would recommend this software to any quality professional."

Thomas R
Quality Systems Manager

*Source: ^{footnote

1}

"Trackmedium has taken extra steps as solution consultants, with design proposed to customize our business requirements. Trackmedium also extended their service on providing supports to integrate Escatec in-house reports, giving us full advantage to migrate the system without impact to customers and suppliers."

Khai Meng L
Corporate Domain Manager

*Source: ^{footnote

1}

"The overall experience is very good. It brings a lot of quality and security to our company's management system."

Irene M
QA/RA

*Source: ^{footnote

1}

"I generally like the integration amongst the document control model and the training model. I super-duper really like the integration from the nonconformance module that leads to the CAPA module and can get linked up to the audit module as well. This helps in generating actions and assessing risks for each module with unique traceable numbers. The setup was fantastic, and the technical team was very knowledgeable, professional, and supportive. We got lots of support and training, which made it quite easy for us to have a switchover. The trackability provided by linking CAPAs to non-conformances and audits is a key feature. It's definitely a 10 out of 10 for me, based on the support I've received and the functionality and ease of the EQMS itself."

Kike I
Quality Assurance Manager

*Source: ^footnote1

"Finally I have found a system that is both highly functional, fully linked between modules and flexible. I have tried many systems over very many years, but never found one that actually meets all my requirements - until Trackmedium. I thoroughly enjoy using this system."

Jane W
QHSE Coordinator

*Source: ^footnote1

Kike I
Quality Assurance Manager

*Source: ^footnote1

Catherine B
Head of Quality and ESG

*Source: ^footnote1

Larry T
Quality Systems Manager

*Source: ^footnote1

"Great, and we would like to use Trackmedium for customer tracking as well to streamline our process."

Sherriann A
APAR Specialist

*Source: ^footnote1

"Very helpful, very friendly, very responsive, fairly priced for what is provided."

Jane W
QHSE Coordinator

*Source: ^footnote1

"Overall experience is great. I would recommend this software to any quality professional."

Thomas R
Quality Systems Manager

*Source: ^footnote1

Khai Meng L
Corporate Domain Manager

*Source: ^footnote1

"The overall experience is very good. It brings a lot of quality and security to our company's management system."

Irene M
QA/RA

*Source: ^footnote1

"We've had a fantastic experience with Trackmedium. The platform itself is excellent - simple to use, powerful, and able to handle every process we've thrown at it. It has replaced timeconsuming manual work with automation that has saved our QA team countless hours. Document control, CAPAs, audits, inspections - everything is smoother and more efficient now."

Denielle Long

*Source: ^footnote1

"The system is purchased with access to all available applications making it flexible to your needs. It is also customisable meaning that where an application doesn't quite fit your needs you can work with the Trackmedium team to easily customise to your requirements. This has made it a valuable and flexible tool in our company."

Catherine Bennett
Head of Quality and ESG

*Source: ^footnote1

Jane W
QHSE Coordinator

*Source: ^footnote1

Frequently Asked Questions

What kinds of deviations can we manage?

Manage temporary deviations involving nonconforming parts and products, as well as processes and engineering documents. Record the original requirement, the actual result, the affected scope, and supporting information.

How does the approval workflow work?

The deviation starts in Initiated and is sent to its owner in Approval. The owner can approve it to Active, send it back to Initiated with a reason, or cancel it. Any contributor input activities must be completed or cancelled before approval to Active.

Can we request input from other teams?

Yes. Create Contributor Input Activities linked to the deviation. Describe the requested input and assign a contributor, who records a response and supporting files. Each activity follows Initiated, In Progress, and Completed, with cancellation and return-for-clarification options.

What happens when the deviation expires?

The record moves from Active to Expired - Pending Product Data Entry, where the owner can finish consuming-product traceability. It then moves to Expired to end the workflow. Manual routing and configured escalations support these transitions.

Can we extend or end an active deviation early?

Yes. The assigned user can extend the expiration date using Extend Deviation. The active record can also be routed manually to Expired - Pending Product Data Entry to end the deviation early.

How do we identify products that used deviated parts?

Use the Consuming Products tab to record serial numbers and sales models, with supporting attachments. Serial numbers can be entered as comma-separated values or ranges; sales models use comma-separated values.

Can we connect a deviation to other quality records?

Yes. Deviations can be created from Nonconformance Management, retaining a parent link. Select affected controlled documents when Document Control is enabled, and use document links to reference other related quality records.

How do users see active and outstanding deviations?

Use views for Pending, Active, Distributed to me, Expired - Pending Product Data Entry, and contributor input activities. My Deviations shows open, non-expired assignments and excludes Active deviations; use Active to review approved exceptions.

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Ready to Bring Temporary Deviations Under Control?
Define the exception, gather the right input, and retain product traceability from approval through expiration.

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Deviation Management

Define temporary exceptions for parts, products, processes, and engineering documents. Gather expert input, approve their use, and retain traceability through expiration.

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