Self‐inspection and classification of non‐compliances

Abstract

Background and ObjectivesSelf‐inspection is a key part of the blood establishment quality management system and the base of different types of assessments. Self‐inspection shall identify if there are problems, deficiencies or non‐compliances against the quality policy, standard operating procedures (SOPs), guidelines, standards and regulations.MethodsThe secret to a successful and efficient self‐inspection is to adopt different standards and requirements, develop a sufficient inspection plan and assess the result and corrective and preventive action. Self‐inspections shall verify compliance with the quality principles and policy of the blood establishment. Usually identify the contents of standards/legislation, quality manual, SOPs as self‐inspection criteria. Self‐inspection planning should include the objectives and scope of the inspection, the inspection team including the staff audited, the self‐inspection audit trail. After completion of the self‐inspection, the inspection report should include an action plan for non‐compliances, measurements for improvement.ResultsAccording to the severity, noncompliances should by classified into categories. Commonly used are as follows: critical, major, minor non‐compliance and observation. Following risk assessment and the implementation of new preventive measurements, a new inspection may be needed and scheduled.ConclusionIn conclusion, self‐inspection is part of a learning process, they should recognize the efforts given by the staff, will help to correct noncompliances effectively, and evaluate the facility's quality and operational systems to determine whether the service they provide is appropriate and in control.