07 - Production Management & Manufacturing Conditions
A manufacturing defect exists if the product deviates from its intended design. There can be intended defects and unintended defects. Intended defects are where the manufacturing processes and procedures have been established incorrectly and the product(s) that is being manufactured is defected. Unintended defects are where the manufacturing processes and procedures have been established correctly, but due to a fault within the process (i.e. Faulty equipment) the products being manufactured are defected. It is imperative that manufacturing processes are controlled to reduce risk of both intended and unintended manufacturing defects.
What do we look for?
- Limited manufacturing experience
- A past record of recalls and product replacement due to manufacturing defects
- Poor production equipment maintenance and high rates of unplanned equipment downtime
- Complex products or products from emerging markets
- Unskilled workforce or rapidly changing workforce.
- Extensive manufacturing experience
- KPIs surrounding manufacturing non-conformances are tracked and monitored
- Stable and experience workforce with ongoing training programs to enhance skills
- Well documented work / task instructions
- Production equipment is regularly maintained and high levels of uptime.
Risk improvement ideas
- Irrespective of the title, ensure that the person responsible for the product manufacturing activities is experienced in various manufacturing quality controls and tools. This person should clearly understand the importance of product safety as well as and ramifications of product liability.
- Establish a rigorous Quality Assurance system across all operations of your business (including product liability) with regular internal / external audits and external certification.