Purpose The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities for initiating, requesting, implementing, and verifying the effectiveness of corrective and preventative actions.
Scope/Application This procedure applies to preventing and correcting nonconformities related to resources, components, subassemblies, completed services, operational processes, and the quality system.
Roles and Responsibilities List the titles of individuals responsible for specific tasks and describe their roles and responsibilities.
Responsibilities
Roles – Title of Responsible Personnel Chief Operating Officer (COO)
Approving and allocating company resources to ensure all preventative and corrective actions, when necessary, are carried out throughout [COMPANY NAME].
Compliance Coordinator (CC)
Authorization of CAR form s. Review and approval of corrective and preventative actions and implementation timelines. Ensures action implementation and conducts necessary follow-up reviews.
Director/Manager
Completing CAR forms when necessary. Implementing corrective actions and communicating changes to necessary external bodies.
Procedure 1. Corrective actions 1.1. Corrective actions are implemented to address actual nonconformities. 1.1.1. Corrective action requests (CAR) may be proposed by any [COMPANY NAME] staff member, but all CARs must be authorized by the Quality Department. 1.1.2. This is to prioritize and direct resources where corrective actions are most urgent.
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[COMPANY NAME] Standard Operating Procedures
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1.2. CARs can be directed to [COMPANY NAME]’s internal departments as well as to its subcontractors. 1.3. Corrective actions may be requested in the following cases:
Identification of a nonconforming process or work operation;
A nonconformity identified during a regulatory or third-party audit, or internal audit;
Customer or regulatory complaint;
Nonconforming operation delivery from a subcontractor;
Identification of any other component, device, process or condition that does not conform to specifications, documented quality system, or requirements of the ISO 17024 or ANSI Essential Elements or applicable regulations.
2. Preventative Actions 2.1. Preventative actions are implemented when there is an increased risk for a potential nonconformity. 2.1.1. The need is identified on the basis of information regarding capability and performance of processes and business operations, service and user feedback, customer complaints, and effectiveness of the quality system. 2.2. Compliance coordinator is responsible for collecting, compiling and reviewing the pertinent information, to include:
Service nonconformity reports;
Customer complaints; and
Quality system audit record.
2.3. Preventive actions are initiated when quality performance data indicates that there are trends of decreasing quality capability and/or effectiveness of the quality system. For example: increasing incidence of service nonconformities traceable to the same common cause or increasing number of audit findings against the same quality system process or department.
2.4. When a problem requiring preventive action is identified, the process of dealing with the problem follows the same steps that apply to corrective actions, as described in this procedure in Section 3, Requesting and Processing CARs. 2.4.1. In subsequent processing stages both types of actions are referred to as corrective actions.
3. Requesting and processing CARs (applies also to preventative actions) 3.1. Corrective and preventive actions are requested using the CAR form.
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[COMPANY NAME] Standard Operating Procedures
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3.1.1. The requests include descr iption of the unsatisf actory condition that needs to be corrected and are addressed to the director/manager responsible for the condition. 3.1.2. The same CAR form is also used t o request corrective actions from [COMPANY NAME]’s subcontractors. 3.2. Upon receiving a request for corrective action, the responsible director/manager investigates the cause of the problem that initiated the request. 3.2.1. Responsible director/manager t hen proposes a correct ive action to be taken, and indicates the date by which the corrective action will be fully implemented. 3.2.1.1. Corrective CAR forms that result from a nonconformance found during an audit shall take priority and be resolved within 45 days of issuance. 3.2.1.2. Preventative CAR forms that result from an audit will be resolved as soon as possible with progress monitored every quarter during Quality Meetings (CC and COO). 3.3. The causes of the nonconformity and the proposed corrective action are documented in the CAR form. 3.4. The CAR form is then forwarded to CC for review and approval of the proposed action and implementation timeline. 3.5. Any implemented changes are reviewed with respect to their impact on current documentation, and the documentation is updated as appropriate. Documentation changes, if any, are recorded in the CAR form and follow all Document Control Policies and Procedures. 3.6. On, or immediately after the due date for the implementation of the corrective action, the auditor follows up with an inquiry or an audit to determine if the CAR has been implemented and sufficiently effective. 3.6.1. Nonconformity reports ar e closed out by the auditor, only when there is objective evidence that the corrective action is effective. 3.6.2. If more work/time is needed to fully implement the cor rective action, then a new follow -up date is agreed upon.
Documentation 1.
The CAR form documents:
Request for corrective or preventative action;
Implementation of corrective/preventative actions; and
Any necessary follow-up actions.
1.1. CAR forms will be stored as a [COMPANY NAME] record; and be held for review and maintenance.
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[COMPANY NAME] Standard Operating Procedures
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1.2. Data will be posted for staff to view, and be used during [COMPANY NAME]’s Internal Audit, Management Review process and Quality Meeting reviews. 2.
Documentation revisions will be logged into the Document’s History; and be subjected to all other Document Control Policies and Procedures.
References [COMPANY NAME]Quality Management Plan
Definitions Nonconformity – is a deviation from a specification, a standard, or an expectation; or the nonfulfilment of a requirement.
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