Corrective and Preventive Action. A corrective and preventive action system will be managed and maintained by Seller as necessary to meet the requirements of the QSR and ISO 13485 or otherwise as a Seller of Products to Buyer in accordance with Section 5.1.
Corrective and Preventive Action. Supplier shall submit a corrective and preventive actions are submitted to Xxxxx quality team within 14 working days after receipt of complaint. Supplier can use 8D process approach to solve the problem or any other method approved by Xxxxx. Supplier shall take approval from Xxxxx quality team on the submitted corrective action report with the proof. Supplier shall provide traceability of improved lot once the corrective actions are implemented. If required supplier shall allow Xxxxx quality team to verify the implemented corrective actions. Xxxxx shall assist supplier in training on 8D process or any other as part of vendor development. For these supplier can contact Xxxxx sourcing team.
Corrective and Preventive Action. Actions taken in response to an incident or Deviation with intent to correct or eliminate the root cause for the occurrence and to prevent reoccurrence.
Corrective and Preventive Action. 5.13.1 KMC Systems Documents 5.13.1.1 781-03021: Request for Corrective and Preventive Action 5.13.1.2 781-03022: Customer Complaint Process
5.13.2 During production, formal requests for Corrective Action may be initiated in accordance with KMC procedure 781-03021: Request for Corrective and Preventive Action. A formal request may be generated when:
5.13.2.1 The Quality System or Manufacturing Process Audits reveal that previous corrective action plans were ineffective or not implemented as planned.
5.13.2.2 Trend analyses of MRC/MRB activities, customer complaints, or audits indicate a system-wide breakdown or failure in a Quality System requirement affecting quality of product.
5.13.2.3 In accordance with KMC procedure 781-03021, Supplier Quality Assurance may issue a Supplier Corrective Action (SCAR), following the disposition of non-conforming material, dispositioned on NCMRs, and after MRC/MRB, in order to address material problems with a particular supplier.
5.13.2.4 In the event that a complaint is received from NxStage, it will be processed through KMC Systems Quality Assurance in accordance with 781-03022: Customer Complaint Process.
Corrective and Preventive Action. 15 4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY . . . . . . . . . . . . . . . . . 16 4.16
Corrective and Preventive Action. CAPA System: A corrective and preventive action as defined in 21 CFR 210 and 211. Certificate of Analysis (COA): A listing of all results for tests conducted on samples of the lot of the Product compared to the specifications and listed in regulatory applications. Certificate of Compliance (COC): A statement that the lot of Product was manufactured, packaged and tested in accordance with cGMPs. Contractee: The facility/organization responsible for defining expectations of the contractor. Contractor: The facility/organization responsible for the manufactured Product and the associated services. Corrective Action: action taken to correct an immediate problem and prevent reoccurence of an undesirable event or deviation. Deviation: Unexpected, unplanned or unforeseeable event, departure from normal processing or operation, or departure from normal or expected values (i.e. out of limits). Investigational New Drug Application (IND): An application submitted to the FDA relative to Investigational New Drug clinical trials. Lot: A Batch, or a specific identified portion of a batch, having uniform composition and quality according to specified requirements.
Corrective and Preventive Action. 17.1. Insulet will establish and maintain a corrective and preventive action (CAPA) program in accordance and compliance with applicable requirements of Regulatory Authorities.
17.2. Trending and analysis of all non-conformances will be performed by Insulet to verify the effectiveness of corrective and/or preventive actions and such trending and analyses will be reviewed with Amgen during the quarterly Quality and Compliance Review.
17.3. After each Non-Conforming Lot and after completing the obligations set forth in Section 16.1 and 16.2 of the Quality Agreement, Insulet and Amgen (through its [*]) shall mutually agree on corrective action to resolve the cause of Non-Conformance, prior to conducting another production run.
Corrective and Preventive Action. Should any audit pursuant to Article 8.1 by CG reveal any deficiencies concerning the performance by the audited Party, the Parties shall without undue delay discuss and agree upon in good faith how to redress such deficiencies and appropriate corrective and preventive action to be taken, and the relevant Party shall undertake commercially reasonable efforts to redress such deficiencies and implement such corrective action. In case audit right is granted to CA, same provisions will apply vice versa.
Corrective and Preventive Action. 11.2.1 Aspect Medical Systems is committed to an operating philosophy that assures that all Aspect products are reliable, safe and effective. Meetings are held at all levels, including the Senior Management level, to assess product trends, problems, and the effectiveness of ATTACHMENT B QUALITY PLAN Page 17/21 corrective and preventive actions.
11.2.2 Customer feedback regarding the performance of our products is objectively reviewed and all reported deficiencies are investigated. Complaints are analyzed and reported to Management on at least a quarterly basis. Likewise, positive customer feedback is also reported. Complaints, as appropriate, are investigated, and, where possible, root cause of the complaint is identified.
11.2.3 When product problems are discovered, appropriate corrective action is undertaken according to established procedures to assure patient safety and compliance with all applicable regulations. In addition, some communications may be undertaken to provide important information or to update our customers, or to update software to a current revision.
11.2.4 The tracking of parameters that relate to manufacturing, such as yields and inspection results at incoming and final, is integral to the improvement of our products, as well as a useful tool in assisting with preventive and corrective action. This information, coupled with product improvements often based on customer feedback, also assists Aspect in achieving our goal of improved clinical outcomes.
Corrective and Preventive Action. The Company reviews incidents of product or process failure with an aim to repair the immediate problem and prevent similar instances of the problem in the future. Training and Development: Critical positions and functions within the quality program undergo regular training and evaluation to ensure that personnel are capable of program functions. General: Additional processes, functions, and systems are in place throughout our operations ensuring quality product, on-time delivery, and accurate order processing. In many cases the company’s internal business systems are catered to operational practices, ensuring process adherence and documentation. Copper State Bolt & Nut Co. supports the ongoing efforts towards environmentally conscious operations, facilities, and practices. The company attempts to utilize “green” materials or processes where practical within our operation and that we adopt practices within all of our facilities aimed at minimizing our impact on the environment. We recognize environmental sustainability as a responsibility we have as an organization to our employees, to our community, to future generations, and to our financial stability. We have structured our program along the criteria of LEED certification. This enables us to capture the LEED credits that may be applied to our own existing sites or new facilities, but also to assist our customers and suppliers that may also be seeking LEED oriented partners. The program is thus aimed at addressing opportunities in the following areas of our operation: Sustainable Sites & Transportation Solutions Water Efficiency Energy & Atmosphere Materials & Resources Indoor Environmental Quality Innovation in operations Our program is dynamic and ever-changing, adapting to new ideas, new solutions, and customer/supplier requirements. Throughout our entire organization we continue to search for ways to improve operational efficiency and environmental sustainability. We welcome customer and supplier contributions towards our program, and will continue to work within our entire community to ensure stable and sustainable operations. Copper State Bolt & Nut Co. has received many requests from customers requiring information and compliance to various regulatory and environmental standards. Copper State Bolt & Nut Co. products are manufactured or purchased according to applicable commercial or other customer specific standards, and our ability to meet the requirements of various directives is...