Quality Control Management Procedure

Company Policy Statement – Suspect Products

If a Customer notifies ANPROS Pty Ltd that a product purchased from the company was found to be defective (i.e. the analysis reagent did not perform satisfactorily) or did not meet the clients required specifications (i.e. the degree of accuracy was not sufficient for the application), then the following steps are to be implemented in order to fully satisfy the needs of the customer.

  1. Attend to the customers complaint or concern with the product as a matter of urgency.
  2. Establish whether a replacement laboratory reagent is required ASAP. The cost of a replacement product & freight to be charged to ANPROS Pty Ltd, depending on the findings of the investigation involving the returned suspect sample. Since the laboratory reagent, in many cases, is being used in a production process, then the hold-up may cause “down- time” to occur and cost money. Consequently, a replacement reagent may be required to be sent to the client ASAP.
  3. Request the customer return the suspect product to ANPROS Pty Ltd for analysis ASAP. Freight to be charged to ANPROS Pty Ltd or credited to the customers account, with the charges, once again dependant on the results of the investigation.
    It is important to request of the customer that the suspect product;
    (a) Be maintained under suitable storage conditions prior to despatch by Post or Courier, etc. This requirement is necessary in order to maintain the product in the best possible condition so that effective analysis of the product can be undertaken.
    (b) Be packaged in a satisfactory manner to ensure that deterioration of the product does not occur during return of the product.
  4. Each manufactured product is provided with: A Product Label containing essential information such as; Product Code, Batch No. and Best by Date, etc, together with:
  5. Having access to the above information together with the suspect product, the cause of the problem can now be undertaken via a detailed analysis.
  6. Each analysis is undertaken three (3) times with each reagent in order to obtain three (3) concordant results. This level of accuracy is equivalent to a statistical significance of > 99.0%.
  7. The results of these tests must be relayed to the client ASAP (i.e. within 5 working days). The most effective means of providing documented results concerning the problem with the laboratory reagent is usually via either email or fax, depending on the preference of the customer.
  8. Once the results of the investigation are conveyed electronically to the client, then a representative from ANPROS Pty Ltd will phone the client in order to make sure that they are fully satisfied with the response undertaken by the company in regard to their complaint and whether there is any thing else that you could do to assist them.