QC (Quality Control) refers to the activities and techniques used to ensure the product quality, including inspection, analysis, improvement, and control of non-conforming products. It generally includes:
- IQC (Incoming Quality Control)
- IPQC (In-Process Quality Control)
- FQC (Final Quality Control)
- OQC (Outgoing Quality Control)
QC focuses on the product, not the system (framework), which is the main difference between QC and QA. Both aim to “meet or exceed customer requirements.”
QA (Quality Assurance) refers to ensuring product quality by establishing and maintaining a quality management system.
QA generally includes roles such as system engineers, SQE (Supplier Quality Engineers), CTS (Customer Technical Service personnel), Six Sigma engineers, and those responsible for the calibration and management of measuring instruments.
QA not only needs to know where the problems lie but also needs to know how to formulate solutions and how to prevent these problems in the future. QC, on the other hand, focuses on controlling problems when they arise but may not need to understand why these controls are necessary.
To give an inappropriate analogy, QC is like the police, who arrest those who break the law, but cannot prevent others from committing crimes or pass judgment. QA, on the other hand, is like the judge, who creates laws to prevent crimes and delivers judgments based on the law.
Summary:
- QC focuses primarily on post-production inspection activities, where errors are assumed to be allowed, and the goal is to identify and correct them.
- QA focuses on proactive quality assurance activities, aimed at preventing errors and reducing the likelihood of defects.
QC is the set of activities and techniques used to meet product quality standards, which includes inspection, correction, and feedback. For example, if QC inspects and finds defective products, they are removed, and the issue is communicated to the relevant departments for corrective actions.
Thus, the scope of QC control is primarily within the factory, with the goal of preventing non-conforming products from being introduced, transferred, or shipped out, ensuring that only conforming products are delivered to customers.
QA, on the other hand, provides confidence to the customer that the products will meet their requirements. This involves managing the entire process, starting from market research and customer requirements review to product development, order processing, material procurement, incoming inspections, production process control, shipment, and after-sales service. QA aims to leave evidence that each step of the factory activities adheres to customer requirements.
QA’s purpose is not to guarantee product quality, as that is the responsibility of QC.
QA’s role is to provide confidence, so it must manage the entire process, from understanding customer requirements to after-sales service. This requires the company to establish a quality management system, develop relevant documentation to regulate activities, and leave evidence of implementation to provide trust.
This trust can be divided into two types: external trust (ensuring customers are confident that the factory produces and delivers products according to their requirements) and internal trust (ensuring the factory owner is confident).
Since the factory owner is the primary responsible party for product quality, and must bear full responsibility if quality issues arise, the laws and regulations in various countries require companies to take product quality seriously. To avoid bearing responsibility, the factory owner must standardize activities through documentation and leave evidence.
However, the factory owner cannot personally monitor whether internal personnel follow the documentation requirements. This is why QA is responsible for audits to ensure that activities follow the documentation, so the owner can trust that operations are being conducted as required.
Therefore, the main difference between QC and QA is that QC ensures the product quality meets specifications, while QA establishes and ensures the system is operating as required to provide internal and external confidence.
At the same time, QC and QA have similarities: both require verification. For example, QC verifies the product by testing it against standards to check if it meets the requirements. QA verifies system operations through internal audits, and also verifies product quality through audits and reliability tests to ensure that the factory delivers products that meet the relevant standards.
QC’s most important responsibility is to monitor finished products (including raw materials, in-process goods, finished goods, and in-process audits), focusing on detecting defects through sample inspection.
QC has IPQC and IQC divisions:
- IPQC: In-Process Quality Control
- IQC: Incoming Quality Control
The responsibilities are as follows:
IPQC Responsibilities:
- Inspect products during the production process and keep records.
- Fill in inspection reports based on inspection records.
- Propose corrective actions for identified issues.
IQC Responsibilities:
- Strictly inspect raw materials according to inspection standards.
- Accurately fill in inspection records.
- Maintain and care for inspection equipment.
- Report any abnormalities in raw materials.
- Label raw materials.
- Responsible for signing off on inspection reports from warehouse personnel.
- Recheck materials in warehouse stock if there are quality complaints from the production line.
QA is responsible for quality supervision/monitoring:
- Oversee the department’s work, implement relevant GMP regulations, and provide quality improvement suggestions to management as needed.
- Ensure that products are produced in compliance with GMP.
- Supervise all quality-related activities within the company, ensuring corrective actions are implemented and issues are prevented.
- Approve instructions beneficial to production after review by designated personnel.
- Review and approve inspection results.
- Review plans and conclusions for new product development and process improvements.
- Review written materials submitted to regulatory agencies.
- Review batch records and determine whether the finished product can be shipped.
- Organize and set quality standards for raw materials, packaging materials, and other documents.
- Review procedures for handling non-conforming products.
- Organize discussions or revisions of technical standards as needed for quality management.
- Review production procedures, batch records, and packaging records to determine product release.
- Handle product quality complaints, assign personnel or personally visit customers, and report findings and actions taken to management.
- Conduct comprehensive GMP audits regularly (at least once a year) with the engineering and production departments, and report the findings to management.