Quality assurance

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

ONLY COMPLIANT PRODUCTS

Compliance testing is often done on one or a small numbers of samples or even prototypes of the final product, so called type-testing. It is however required that compliance is maintained during mass production. Manufacturers and others involved in the supply chain shall take measures to verify that every produced product is compliant. Factories need a quality management system. Importers need to monitor the performance of such system.

Obligations

Manufacturers shall ensure that procedures are in place for (series) production to remain in conformity.
This obligation means manufacturers shall:

• Take into account all changes in product design, procurement of materials and components;
• Carry out sample testing of products to protect the health and safety of consumers;
• Register and investigate complaints, non-conformity records and product recalls.

Who is involved?

Actually everybody is involved because the compliance of a product can be at risk from the first design to the last item shipped. Quality management procedures shall be in place for design, engineering, purchasing, supply management, production, warehousing, packaging, transport, delivery, sales, customer service of course under governance of the quality department and management.

Quality system – What a factory should do
The quality system of a factory (supplier) shall include procedures on assurance of the compliance of the manufactured products. The factory shall document quality programmes, plans, manuals and records.
Typical quality management elements of product compliance monitoring are:

• IQC: Incoming Quality Control; also knows as incoming goods inspection. Records of tests and examinations carried out before production starts. Check the procured materials and components against the specifications.
• IPQC: In-Process Quality Control; all actions performed during production to verify that the products meet the requirements. In-production tests must be smart and quick to avoid expensive delays in manufacturing times.
• FQC: Final (or finished) Quality Control; all tests that are done directly after the production has been completed in the factory (post-production) to determine if any rework or revision is necessary;
• OQC :Outgoing quality control; a final check before the products leave the production warehouse.

Quality system – third party audits and certifications

Suppliers may have a certified quality system and that could reduce the need for inspections. ISO 9001 provides a good basis for quality assurance systems.
There are also specific standards for quality systems: ISO 13485 for medical devices, IATF (ISO/TS) 16949 for the automotive industry, ISO/IEC 25000 for quality of software and ISO 22000 for the Food Supply chain. In the case of Food Contact Materials a certified quality system – Good Manufacturing Practice – is even mandatory since 2006!
And for some products, typically with a higher risk, mandatory involvement of Notified Bodies may be required also for the conformity of production.

More obligations in the supply chain

Importers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of such monitoring.
This obligation is obviously more important when the risks presented by a product are high.

Quality system – What an importer (purchaser) should continuously monitor

Even with a quality minded or certified supplier you may want to monitor the compliance of the purchased products. As an importer you are placing products on the (EU) market and as such you need to regularly monitor the quality of your products from the promises of the factory to the satisfaction of your customers.

Audits and inspections, examinations of products before they are shipped are the instruments that you have, such as:

• IPC: Initial Production Check; performed before mass production starts, up to 20% of the order;
• PSI: Pre-shipment inspections; performed when 80% of the order is completed;
• DUPRO: During Production inspections performed when 20-80% of the order is completed;
• CLC: Container Loading Check: Last minute quick scan during container loading;
• PM: Production Monitoring: On site during every day of the production;
• RFI: Random Factory Inspections; unannounced on site inspections.

Other elements may be in-store testing, consumer panels, fitness-for-use and performance testing, etc.
Preventive and corrective actions. Customer complaints, including those on social media, must also be monitored. They could be an indication that despite all the efforts something still has gone wrong.