ISO 13485 from zero, episode six: production controls and process validation.

What does this episode cover?

This is episode six of ISO 13485 from zero. Design is done, suppliers are controlled, and now the device has to be made, the same way, every time. This episode covers production controls, traceability and the validation of processes that cannot be fully verified.

What are controlled conditions?

Production must be planned and carried out so that product conforms to specification. In practice that means documented procedures and work instructions where needed, qualified infrastructure, monitoring and measurement at the right points, defined release, and labelling and packaging operations under control.

How do you handle cleanliness and contamination?

Where it matters for the device, ISO 13485 expects documented requirements for product cleanliness, and control of the work environment and of contamination. That might mean cleanroom classifications and monitoring for some products, or simply defined cleaning and handling for others. Decide what your devices need, write it down, and keep the monitoring records.

What is a device history record?

For each batch or unit, a record that shows the quantity manufactured and approved for distribution, and allows traceability. It should identify the materials and component lots used, the equipment, the key process parameters, the inspection results, any nonconformances, and the release by an authorised person.

Template for this step: the batch record, DHR index and product release workbook are in the ISO 13485 Production & Traceability Kit ($99).

How far should traceability go?

Define the extent of traceability for each device, based on its risk and the regulations. For implantable devices, ISO 13485 expects traceability of components, materials and, where relevant, environmental conditions. Make sure you can follow a device forwards to the customer and backwards to its inputs.

When must a process be validated?

Any process whose output cannot be, or is not, verified by later monitoring or measurement must be validated. Typical examples are sterilisation, sealing of sterile barrier packaging, moulding, welding and bonding. Validation usually runs in three steps. Installation qualification confirms the equipment is installed correctly. Operational qualification establishes the process window that produces good product. Performance qualification shows the process consistently produces good product under normal conditions.

What about software in production?

Software used in production and service, such as automated test equipment, label printing software or machine control software, must be validated for its intended use before first use, and after changes, in proportion to the risk.

The ISO 13485 Production and Traceability Kit and the Process Validation IQ/OQ/PQ Pack cover these areas. Previously: purchasing and suppliers. Next episode: complaints, vigilance and post-market surveillance.