Deviation Reports Sample Clauses

The Deviation Reports clause requires parties to formally document and communicate any departures from agreed-upon specifications, procedures, or standards during a project or contractual engagement. Typically, this involves submitting a written report detailing the nature of the deviation, its cause, and any proposed corrective actions, which may then be reviewed and approved by relevant stakeholders. By establishing a clear process for identifying and addressing deviations, this clause helps maintain quality control, ensures transparency, and minimizes the risk of misunderstandings or disputes related to non-conformance.
POPULAR SAMPLE Copied 1 times
Deviation Reports. TVA shall report all deviations from the requirements of the Compliance Agreement that occur during the calendar year covered by the annual report, identifying the date and time that the deviation occurred, the date and time the deviation was corrected, the cause of any corrective actions taken for each deviation, if necessary, and the date that the deviation was initially reported under Paragraph 156.
View SourceView Similar (4)
Deviation Reports. If during the manufacture or other handling of a Product by Supplier (i) the process or tested Product limits and quality measurements vary from typical or established report ranges, release guidelines or release limits, (ii) Specifications were not followed in production of the Products, or (iii) the Products fail to conform to Specifications, then Supplier shall prepare as soon as practicable following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send such Deviation Report, along with all supporting documentation, to NCR and to all Designated Purchasers.
View SourceView Similar (2)
Deviation Reports. If during the manufacture or other handling of Product by Adolor (a) the process or analytical limits vary from typical or established report ranges, release guidelines or release limits, (b) there is reasonable evidence that Specifications or cGMPs were not followed in production of the Products, (c) there is reasonable evidence that the Products fail to conform to Specifications, (d) other events or conditions occur (including, without limitation, events first identified as affecting non-GSK products) which could reasonably be expected to adversely affect the quality of the Products or otherwise are unusual or not expected, or (e) any physical characteristic or attribute of the Products is recognizable at any time during the manufacturing process to be unusual, atypical or irregular by a person with appropriate technical knowledge and experience exercising his best professional judgment, then Adolor shall prepare as soon as practicable following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send such Deviation Report, along with all supporting documentation, to GSK. Adolor shall include in its Deviation Report its analysis and recommendation for Product disposition. The Deviation Report shall be attached to, and shall accompany, copies of all relevant batch records.
View SourceView Similar (2)
Deviation Reports. If during the manufacture or other handling of a Final Product by GLAXO, (i) the process or analytical limits vary from the typical or established report ranges, release guidelines, or release limits, (ii) Specifications or cGMPs were not followed in the production of the Products, or (iii) the Products fail to conform to Specifications, then LGLS shall provide to GS, or cause GLAXO to provide to GS, the written report detailing such deviation (“Deviation Report”) prepared by GLAXO, along with all supporting documentation. The Deviation Report shall be attached to, and shall accompany, copies of all relevant batch records. Any batch or shipment of Final Product that is the subject of a nonconformity or a Deviation Report shall not be shipped to GS, unless otherwise directed by GS, or, if such Final Product was shipped and is held in stock by GS, then it shall be given a “Hold” or “Unpassed” status and shall not be released into the passed inventory of GS until GS has completed any investigations related to such Products and approved the disposition of the Final Product. GS shall provide written instructions to LGLS regarding the destruction of any nonconforming Final Products. The cost of destruction and the replacement cost of Final Product *****.
View SourceView Similar (2)
Deviation Reports. If, during the manufacture or other handling of a Product by Patheon, (i) the process or analytical limits vary from typical or established report ranges, release guidelines or release limits, (ii) there is [ * ] evidence that Specifications, the Quality Agreement, cGMPs or Laws were not followed in production of the Products, (iii) there is [ * ] evidence that the Products fail to conform to Specifications, (iv) other events or conditions occur (including, without limitation, events first identified as affecting non-XenoPort products) that could [ * ] adversely affect the quality of the Products or otherwise are [ * ], or (v) any physical characteristic or attribute of the Products is recognizable at any time during the manufacturing process to be [ * ] by an individual with appropriate technical knowledge and experience [ * ], then Patheon will prepare [ * ] following the discovery of the deviation a written report detailing the deviation (a “Deviation Report”) and promptly send the Deviation Report, along with all supporting documentation, to XenoPort. Patheon will include in its Deviation Report its analysis and recommendation for Product disposition. The Deviation Report will be attached to, and will accompany, copies of all relevant batch records.
View Source
Deviation Reports. If, during the Manufacture or other handling of a Product by Impax, (i) the process or analytical parameters vary from typical or established report ranges, release guidelines or release limits, (ii) there is reasonable evidence that Specifications, the Quality Agreement, cGMPs or Laws were not followed in production of the Products, (iii) there is reasonable evidence that the Products fail to conform to Specifications, (iv) other events or conditions occur (including, without limitation, events first identified as affecting non-GSK products) that could reasonably be expected to adversely affect the strength, safety, identity, purity and quality of the Products or otherwise are unusual or not expected, or (v) any physical characteristic or attribute of the Products is recognizable at any time during the manufacturing process to be unusual, atypical or irregular by an individual with appropriate technical knowledge and experience exercising his or her best professional judgment, then Impax shall investigate the matter pursuant to provisions of the Quality Agreement and this Supply Agreement and, only if such matter is a Critical Deviation or Major Deviation (as such terms are defined in the Quality Agreement), prepare as soon as practicable following the discovery of such Critical Deviation or Major Deviation a written report detailing such Critical Deviation or Major Deviation (a “Deviation Report”) and send such Deviation Report, along with all supporting documentation, to GSK prior to the shipment of the Product. Impax shall include in its Deviation Report its analysis and recommendation for the disposition of the Product in the Deviation Report.
View Source

Related to Deviation Reports

  • Construction Reports Each Constructing Entity shall issue reports to each other Construction Party on a monthly basis, and at such other times as reasonably requested, regarding the status of the construction and installation of the Interconnection Facilities. Each Construction Party shall promptly identify, and shall notify each other Construction Party of, any event that the Construction Party reasonably expects may delay completion, or may significantly increase the cost, of the Interconnection Facilities. Should a Construction Party report such an event, Transmission Provider shall, within fifteen days of such notification, convene a technical meeting of the Construction Parties to evaluate schedule alternatives.

  • Evaluation Reports Where a formal evaluation of an employee's performance is carried out, the employee shall be provided with a copy to read and review. Provision shall be made on the evaluation form for an employee to sign it. The form shall provide for the employee's signature in two (2) places, one indicating that the employee has read and accepts the evaluation, and the other indicating that the employee disagrees with the evaluation. The employee shall sign in one of the places provided within seven (7) calendar days. No employee may initiate a grievance regarding the contents of an evaluation report unless the signature indicates disagreement with the evaluation. The employee shall receive a copy of the evaluation report at the time of signing. An evaluation report shall not be changed after an employee has signed it, without the knowledge of the employee, and any such changes shall be subject to the grievance procedure.

  • Inspection Reports A "full inspection report" comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A "detailed report" responds to specific queries about a firm by the other Party.

  • Evaluation Report The state must provide a narrative summary of the evaluation design, status (including evaluation activities and findings to date), and plans for evaluation activities during the extension period. The narrative is to include, but not be limited to, describing the hypotheses being tested and any results available.

  • Implementation Report Within 150 days after the Effective Date, Ensign Group shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, address, phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names and positions of the members of the Board of Directors who are responsible for satisfying the Board of Directors compliance obligations described in Section III.A.3; 4. a copy of Ensign Group’s Code of Conduct required by Section III.B.1; 5. the number of individuals required to complete the Code of Conduct certification required by Section III.B.1, the percentage of individuals who have completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG upon request); 6. a summary of all Policies and Procedures required by Section III.B (copies of the Policies and Procedures shall be made available to OIG upon request); 7. the following information regarding each type of training required by Section III.C: a. a description of such training, including a summary of the topics covered, the length of sessions, and a schedule of training sessions; b. the number of individuals required to be trained, percentage of individuals actually trained, and an explanation of any exceptions. A copy of all training materials and the documentation supporting this information shall be made available to OIG upon request. 8. a description of the Disclosure Program required by Section III.E; 9. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between Ensign Group and the IRO; and (e) a certification from the IRO regarding its professional independence and objectivity with respect to Ensign Group; 10. a description of the process by which Ensign Group fulfills the requirements of Section III.F regarding Ineligible Persons; 11. a list of all of Ensign Group’s locations (including locations and mailing addresses); the corresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; each location’s Medicare and state Medicaid program provider number and/or supplier number(s); and the name and address of each Medicare and state Medicaid program contractor to which Ensign Group currently submits claims; 12. a description of Ensign Group’s corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and