Corrective actions: automatically trigger investigations and steps to correct identified problems and prevent reoccurrence.

CAPA - Corrective And Preventive Actions - for identifying and solving quality issues.

Product sampling - random checks against formal criteria that test for quality consistency.

Inspection - analysing processes and production lines to ensure quality is maintained.

Tests - formal, documented tests of products that take place at appropriate intervals.

Quality Control activities begin once a product has been manufactured - these requirements are specified in various quality standards and regulations.

Regular process audits - ensuring no quality gaps or risks have emerged in the way you work.

Change control - ensuring all engineering and quality changes are planned, approved and monitored effectively.

Training management - ensuring everyone understands and follow best practice and SOPs.

Managing supplier quality - ensuring consistency and quality of the raw materials/components/3rd party services you use.

Documenting SOPs (standard operating procedures) - making them clear, easy to follow and replicate exactly.

Required QA processes are specified in quality standards like ISO 9001 and ISO 13485. These processes should ensure your team always design and manufacture products in a uniform way, according to requirements and specifications. Throughout your product development cycle, you should create QA processes that will help you deliver products of consistent quality.

ISO describes QA as the 'part of quality management focused on providing confidence that quality requirements will be fulfilled'. Quality Assurance (QA) activities, on the other hand, are the actions you must take to ensure products are always manufactured to certain specifications and quality standards. Typical QC activities include batch testing and sampling to ensure consistency of output. Quality Control (QC) are the tests carried out to ensure products work as intended before they are distributed. But how do you make your response to these demands as Lean and efficient as possible? What is Quality Control (QC)? They’re both requirements of ISO quality standards and regulations like the FDA’s 21 CFR PART 820. QC is about detecting defects in your finished product, while QA is about preventing the defects from occurring in the first place.

Qms qa qc