Non-Conformance Investigation

We have got expertise in Quality Non-Conformance Investigation. We work on your behalf with your manufacturer to dig out the root cause of issues and offer preventive action solutions.

What is Non-Conformance?

A manufacturer, seller, packager, labeller or distributor ensures that they continue to offer quality products and operate correctly under existing regulations of Health Canada or FDA. If they fail to operate up to standard regulations, it’s called non-conformance. Nonconformity can be detected at any level of an organization’s operations from manufacturing and quality control to personnel procedures. Any company that fails to adhere to regulatory compliance must get the problem detected and resolved before continuing business.

Why the Need for Non-Conformance Investigation?

If you manufacture or sell goods, you should work out to deal with nonconforming product. Your priority must be to stop nonconforming products from reaching consumers. Non-conformance investigation solutions will empower you to identify issues, determine what actions need to be taken immediately to fix those issues, stop any further processing of defective products, and prevent further non-confirmation.

Here from Some of Our Amazing Clients

Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada

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Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

    What Is a Non-Conformance Report?

    A non-conformance report is a document that identifies any aspect of a product or service that does not meet the required standards. It includes details such as the description of the issue, cause of failure, proposed corrective action, and responsible person. Non-conformance reports are a way for businesses to ensure the quality of their products and services and allow for enhanced decision-making for future process improvement efforts.

    The real benefits of well-written SOPs are crucial to the quality of the work functions performed. Detailed instructions can be read by any and every employee in the corporation. Thus, employees will be capable of easily performing the SOP function. 

    Identifying and Analyzing the Issue
    Develop Intended Corrective Actions
    Implement Action Plan to Resolve Issues
    Continuous Improvement with Non-Conformance Reporting
    Non conformance reporting

    Identifying/Analyzing the Issue & Developing Corrections:

    A non-conformance report should be thorough in identifying and analyzing the issue. This can include research in to what exactly caused the issue, who is involved and responsibilities that need to be taken, as well as ways of preventing it from happening again. Taking proactive steps such as root cause analysis will help ensure the issue does not persist or come up again down the line.

    Once the issue has been recorded and analyzed, it’s time to determine what corrective actions will be taken to ensure a similar matter does not arise in the future. It is recommended that these corrective actions are detailed, measurable, and actionable – meaning the person tasked with carrying out the steps needed to restore the non-conformance’s can quite clearly see what needs to be done and engage full-on confidence to make it happen. After all, if you cannot precisely measure a task you’re are given then how do you know of its successful completion? Create clear steps necessary for correcting any irregularities found upon further testing or investigation.

    Implement your Action Plan & Constantly Improve with Non-Conformance Reporting:

    After the corrective action plan is created, it is time to execute on it. This involves assembling the necessary personnel and resources needed to complete the given task while also clearly outlining timeline expectations and goals in terms that can be tested or definitively measured. Make sure to assign someone specific responsibility for each corrective action and track progress along the way. Doing so allows companies to demonstrate compliance with regulatory requirements, standards, and commitments, thus ensuring that non-conformance does not reoccur down the road.

    Good non-conformance reports provide management with key information into system failures to identify, measure and improve any process weaknesses. Incorporating a non-conformance report can help generate greater customer satisfaction and improved regulatory compliance. Identifying, documenting, and measuring root causes allow your team to use the data collected to implement corrective action plans that lead to long-term continuous improvement.

    Why Us for your Non-Conformance Investigation

    Partnering with us will let you get assistance from experienced non-conformance investigation specialists. We will work with you to find the reason for any issue; and provide a corrective and preventative action summary, if applicable. We will then send the non-conformance report back to you, and you can choose to report those findings back to your customer.

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    Internal Non-Conformance Investigators

    We have a team of skilled and talented internal non-conformance teams to work with you.

    Capture Customer’s Concerns

    We capture your customer’s concerns in a complaint document form, investigate, and prepare a non-conformance report for you.

    Privacy Protection

    Without disclosing your customer’s information, we’ll investigate on your behalf; work with your manufacturer to find the reason for the issue.

    Customer Complaint Center

    We will act as your trusted customer complaint handler, Customer Complaint Center, or your Investigator of non-compliance or quality issues.

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