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Ishikawa diagram and accountability4/16/2023 ![]() The following example DR is generated from a cold chain breach. Although simple, if not properly documented, it could lead to recurrence of the same event. The next step is to log the 'immediate corrective action' taken. Why did staff take on responsibilities belonging to another area?.Why weren't staff trained in specific procedures?.Are SOPs clear and accurate with defined lines of responsibility and accountability?.What information or evidence was used to justify the decision?.At this stage the Deviation Investigator should ask, for example: trend analysis, customer complaint.Ī Deviation Report (DR) is populated with evidence gathered during deviation handling. This 'evidence' is used to both log and trend an event (stop here) or raise a deviation for investigation from e.g. What is being reported? See Figure 1 for examples. The first step is to accurately detect the event. (2) Objectivity: Be open, truthful, concise, clear and accurate. SOPs, Airway Bill, Copies of shipping documents, temperature printouts. Proper deviation handling provides a framework for a decision making process based on: (1) Evidence: Document everything known, providing references where available e.g. And prior to commencing the investigation the definitions used in a CAPA system must be properly understood. Prior to an organisation identifying Corrective Action(s) and Preventive Action(s) it is important to work through a systematic investigative process at each link of the chain of events to identify actual or potential "failures" or deviations from the expected norm. Simply put, the solution mustn't cause another problem elsewhere in the system or organisation, either imminently or in the future. Secondly, understand the identified solution must be lasting and must not cause a ripple effect into other business areas. identify the 'problem' which requires a solution. To ensure a CAPA system is implemented and used correctly firstly identify all the steps leading to an event/risk/ issue/non-conformance i.e. Good Distribution Practice (GDP) Guidelines and Good Manufacturing Practice (GMP) Guidelines require organisations to implement effective Corrective Action and Preventive Action (CAPA) systems. ![]()
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