Ensuring ongoing conformity of production

SATRA’s quality, testing and inspection services can help to prevent sale of unsatisfactory products.

Supplying sub-standard products can have many unfortunate consequences – ranging from loss of business, financial and reputation damage, through to fines or even imprisonment if a serious safety offence has been committed.

Manufacturers generally have in place formal procedures for assessing initial designs and prototypes prior to full-scale production. These may also include some form of ‘risk assessment’ to ensure the product suits the market, satisfies any specific performance requirements and standards as well as more generally appropriate legislative requirements such as ‘restricted substances’, labelling and instructions for use.

However, after establishing the suitability of prototypes or limited initial production, it is also important to ensure consistency of all subsequent manufacture, to maintain ‘ongoing conformity’. Established and effective procedures will help with a due diligence defence if a problem does occur, and may satisfy a court that the supplier ‘took all reasonable steps’ to prevent an inappropriate product from being placed on the market.

So how can manufacturers implement ongoing conformity procedures? Typically, quality assurance systems, quality control inspection and testing are the key considerations, although the best way to minimise defects is to build good quality into the product in the first place rather than trying to inspect poor quality prior to despatch.

A typical quality assurance system will incorporate an independent quality function within the organisation. It will have documented procedures and established goods inwards control coupled with in-process testing, inspection and a final product check. This does not need to be a full ISO 9001 system, but many organisations recognise the benefit of using a recognised certification body – such as SATRA – to accredit the system and issue a formal ISO 9001 certificate. As well as providing customer confidence, it is often quoted in support of due diligence.

Inspection of products is a key quality control process for many manufacturing organisations. Even those with quality management systems such as ISO 9001 often have some form of raw material, in process or final inspection. For some companies without a formal quality management system, inspection and testing may be the only means of confirming product quality and is often a contractual obligation.

Periodic testing is often associated with quality control and quality assurance systems. To ensure that products continue to comply they should be tested regularly, perhaps for limited key properties and backed up by a periodic full test.

Using some form of sampling programme can help determine the amount of inspection and test required such as ISO 2859-1. Although this has the disadvantage that not all products are inspected, the risks involved can be calculated and a plan chosen that satisfies both manufacturer and customer. Based on an agreed acceptable quality level (AQL), the customer accepts batches of product, provided that the number of production non conformities does not exceed a defined amount (after a percentage of products have been inspected from a batch). As the sampling plan is based on mathematical probability, it is assumed that the remainder of the batch will exhibit similar characteristics.

---