Laatupoikkeamana

Laatupoikkeamana is a Finnish term used in quality management to designate an instance, data, or action that is treated as a deviation from the required quality. It functions as an adverbial form describing how something is handled or categorized within a quality system.

The term is common in manufacturing, pharmaceuticals, laboratories, and service industries that maintain formal quality management. It refers to situations where product specifications, process parameters, or documentation do not meet defined requirements. Laatupoikkeamana is used to label and communicate such situations so that appropriate actions can be taken.

Examples include a batch failing a quality checkpoint, a measurement outside specification, mislabeled packaging, incorrect batch coding, or supplier material that does not meet agreed criteria. In each case, the deviation is identified, investigated, and documented to prevent recurrence and to assess any impact on safety, performance, or compliance.

Typical handling follows standard quality procedures: detection and containment of the issue, recording in a nonconformity or deviation report, root cause analysis, and the implementation of corrective and preventive actions (CAPA). In many quality systems, a laatupoikkeama initiates investigations under frameworks such as ISO 9001, ISO 13485, or other industry-specific guidelines.

Linguistically, laatupoikkeamana is an inflected form that functions to indicate “as a quality deviation” and is used with related terms like laatupoikkeama or poikkeama. See also poikkeama, laatupoikkeama, and poikkeamaraportti for related concepts.