Product specifications (specs for short) are a record AsureQuality creates and stores in our laboratory information management system (LIMS) to ensure consistency of testing parameters and service delivered. Specs are a list of tests, or a testing programme, for a specific product, often linked to quality, compliance and export requirements. Laboratory testing can be very complex, and we have thousands of different tests with numerous variations in the way they are run depending on factors such as the reason for testing, the customer's needs and the specific sample type/composition.
There are two categories of product specifications:
AsureQuality specifications: AsureQuality has a number of specifications that we maintain for common sample types and testing situations. These are available to everyone via LabConnect so that in the absences of customer restricted specifications they can be applied to your samples when registering for testing.
Customer restricted specifications: Many customers require their own product specifications to be available only to themselves for their unique requirements. These are only available to the specific customer organisation and can be referenced on manual submission forms, interface registrations and on LabConnect so that they can be applied to your samples when registering for testing.
Both categories are generally organised by specific sample types (e.g. low-fat liquid cow milk, corn flour, etc.) or products (e.g. Mammy’s Fabulous Infant Formula). However, some customers have such little variation between their products they may have specs to suit specific testing needs, such as China Overseas Market Access (OMAR), Canada OMAR, China Nutritional Information Panel (NIP), or Thailand NIP. And in some cases, customers will make specs into specific combinations of all of these, Honey to China for example.
What information can a spec contain?
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A detailed sample type/matrix description such as "Vitamin A, E & C fortified premix powder" or "Dried Fish Maw"
- The specific analyte(s) to be tested for
- The acceptable limits for test results (customer restricted specs only)
- The required unit of measurement to be reported
- The purpose of testing, whether a specific accreditation need to be provided such as IANZ.
What if I'm reluctant to provide you that level of detail?
We understand and respect that the compositional makeup of your products is your intellectual property, and it can be daunting to share this information externally. However, as your chosen testing partner our primary concern is ensuring the services we deliver to you are as accurate and timely as possible.
What are the benefits of using specifications?
When you submit your samples using customer restricted or AsureQuality specs, it ensures that AsureQuality are testing to your specific requirements such as:
- the correct method and accreditation for sample specific market access requirements
- the correct units of measure required, for consistency and comparison against other results
- the correct reporting name for your needs - important where analytes have multiple names
- the correct dilutions are used to obtain the right result first time, reducing delays and waste.
Using specs:
- significantly reduces errors that cause delays and unexpected results
- speeds up sample submission on both LabConnect and interface pre-registration
- simplifies the completion of manual submission forms
- allows you absolute control over what specific testing criteria is applied to your samples
- allows you to select limits for your tests, so you can be notified as soon as the test is reported if it is outside of those limits (out-of-spec notification).
- customers that are part of the MedSafe cGMP programme are required to have the spec details including test limits shown on every Certificate of Analysis (CoA)
Using specs also helps AsureQuality to perform your testing to a high standard.
- it makes our registration and testing process significantly more efficient.
- it prevents our laboratory team having to make assumptions about your requirements in the absence of information.
- it prevents delays in sample registration (receipt) due to having to gather additional information.
- it ensures we are selecting the correct test for the sample type and testing need.
- if there is an out-of-spec notification, it highlights to our laboratory team to investigate and discuss with you.
How can I get my specs set up?
To set up your specs with us we need the following:
- Prior to sending any new samples to us for testing (ideally two weeks prior) provide a spec for the sample(s) so that we can have it setup and ready to use before you need it.
- If preferable a copy of your current internal specs document can be used.
- If you do not have your specs documented internally feel free to use our template (available for download at the bottom of this article)
- If you need guidance on the options available please see this article.
- Whenever there is a spec change, please notify us so we can update to your latest version and archive the previous version.
- Think about including this as early as possible in your Change Management process.
Contact our dedicated Specifications Team directly for any of the following:
- Request an extract of all your current product specifications for review
- Setup of new product specifications for your testing needs
- Update individual existing product specifications
- Request archival of a disused product specification
- Any other query directly related to product specifications.
See our video tutorial on How to register a sample using specifications in LabConnect.
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