Manufacturing Control Procedure ISO 9001 2015 | QP1140

Manufacturing Control Procedure

The Manufacturing Control Procedure delineates processes followed in the manufacture, inspection, and packaging of product for the customer’s use in conformance with ISO 9001:2015.

This procedure applies to all personnel involved in the production and handling of your company products and their components. (10 pages, 1841 words)

Manufacturing Control Responsibilities

The Production Manager is responsible for managing the company’s production processes, ensuring that all personnel, materials, and equipment needed to create and maintain the production schedule are available and able to function as expected. The Production Manager is also responsible for ensuring that Production personnel receive adequate training to perform their assigned duties and that they have complete, accurate, and up-to-date production documentation.

The Manufacturing Manager is responsible for producing the company’s end product(s) in a manner that ensures quality and meets statutory/regulatory and customer requirements.

Warehouse Personnel are responsible for picking product components and sending them to Production.

The Quality Assurance Manager is responsible for monitoring and measuring all manufacturing (i.e., product realization) processes, to ensure company products conform to requirements.

Manufacturing Control Definitions

Benchmarking – Performance measurement tool used in conjunction with improvement initiatives, it measures comparative operating performance of companies and identifies best practices.

Enterprise Resource Planning (ERP) – Information system or process that integrates manufacturing and related applications for the entire enterprise (e.g., product planning, parts purchasing, maintaining inventories, interacting with suppliers, providing customer service, and tracking orders).

Flow diagram – Paths of movement of workers or materials, superimposed on a graphical representation of the work area; also called a “process map”.

Key characteristic – Special feature of a material, part, or process, variation of which will significantly influence a product’s fit, performance, service life, or manufacturability. Key characteristics are essential to meeting product goals are identified so that the Company’s resources can be focused on those items.

Kanban – Japanese term for a Lean signal method for balancing workflow with the goal of single piece flow.

Product realization – Act of bringing a product or service into existence (aka, “manufacturing the product”). “Realization” is a broader term than “manufacturing” or “production”, so its use is increasing as services make up a larger share of the economy.

Statistical process control – (SPC) calculations that derive the process variability from the mean to detect special cause variation.

Manufacturing Control Activities

• Production Control
• Product Realization
• Inspection and Testing
• Packaging and Labeling
• Final Verification & Release
• Production Change Control

Manufacturing Control References

• ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
• Quality Procedures
  • QP1000 Documented Information Control
  • QP1030 Nonconforming Output Control
  • QP1040 Nonconformity Corrective Action
  • QP1150 Identification Traceability
  • QP1160 External Property
  • QP1170 Monitoring-Measuring Resources Control
  • QP1180 Monitoring-Measurement

Manufacturing Control Forms

• Inspection/Testing Checklist
• Product Release Authorization