Deviation Control Sample Clauses

Deviation Control. KBI Biopharma will notify the Client of any out of specification (OOS) results or other Critical/Major Deviation(s) within one (1) business day of confirming an OOS or identifying a Critical/Major deviation. OOS results will be investigated using the KBI Biopharma Laboratory Investigation Procedure, and if any retesting is conducted, the re-test plan must be approved by KBI Biopharma quality and the Client Quality Contact. For assays where there is a limited storage hold time for the Quality Control sample, the Client will provide timely (same business day may be required) approval on the retest plan. Critical and Major Deviations will be investigated for root cause, product/process impact and fully documented by KBI Biopharma, targeting thirty (30) days after the date of discovery for completion. Investigations will include appropriate justification, scientific rationale and supporting data. The Client will review the completed Deviation report and communicate to KBI Biopharma the result of its review, within five (5) business days. Copies of all batch related deviation reports will be provided to the Client as part of the batch disposition documentation.
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Deviation Control. KBI BioPharma will notify Client of any out of specification (OOS) results or other Critical Deviations within three (3) working days of confirming the OOS or observing the deviation. OOS results will be investigated using the KBI BioPharma Laboratory Investigation Procedure, and if any retesting is conducted, the re-test plan must be approved by KBI BioPharma quality and the Client Quality Contact. Critical Deviations outside of OOS investigations will be investigated for root cause and fully documented by KBI BioPharma, targeting thirty (30) days after the date of discovery for completion. Investigations will include appropriate justification, scientific rationale and supporting data. The Client will review the completed Critical Deviation report and communicate to KBI BioPharma the result of its review, within five (5) business days.

Related to Deviation Control

  • Erosion Control a. The Purchaser shall construct slash and debris erosion barriers, dips, water bars or ditches in skid trails and landings as directed by the Forest Officer. b. The kinds and frequency of erosion control structures shall be adjusted to soil types, topography and climatic conditions as directed by the Forest Officer. c. The Purchaser is required to recontour any excavated skid trails, and provide for effective erosion control in the trail location as directed by the Forest Officer. d. Erosion control work shall commence as soon as skidding is completed on each skid trail or landing, and must be kept current with unit operations. e. Erosion control work shall be completed and approved by the Forest Officer in unfinished units before operations cease for inactive periods including heavy winter snowfall, spring breakup and restricted dates. f. All erosion control work in each unit shall be completed prior to notification pursuant to Section VII.M.7.

  • Construction Management Plan Contractor shall prepare and furnish to the Owner a thorough and complete plan for the management of the Project from issuance of the Proceed Order through the issuance of the Design Professional's Certificate of Material Completion. Such plan shall include, without limitation, an estimate of the manpower requirements for each trade and the anticipated availability of such manpower, a schedule prepared using the critical path method that will amplify and support the schedule required in Article 2.1.5 below, and the Submittal Schedule as required in Article 2.2.3. The Contractor shall include in his plan the names and resumés of the Project Superintendent, Project Manager and the person in charge of Safety.

  • Operational Control Directing the operation of the Transmission Facilities Under ISO Operational Control to maintain these facilities in a reliable state, as defined by the Reliability Rules. The ISO shall approve operational decisions concerning these facilities, made by each Transmission Owner before the Transmission Owner implements those decisions. In accordance with ISO Procedures, the ISO shall direct each Transmission Owner to take certain actions to restore the system to the Normal State. Operational Control includes security monitoring, adjustment of generation and transmission resources, coordination and approval of changes in transmission status for maintenance, determination of changes in transmission status for reliability, coordination with other Control Areas, voltage reductions and Load Shedding, except that each Transmission Owner continues to physically operate and maintain its facilities.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Job Control Personal Data being processed on commission (i.e., Personal Data processed on a customer’s behalf) is processed solely in accordance with the Agreement and related instructions of the customer.

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time. B. Controlled Affiliate agrees to comply with all applicable federal, state and local laws. C. Controlled Affiliate agrees that it will provide on an annual basis (or more often if reasonably required by Plan or by BCBSA) a report or reports to Plan and BCBSA demonstrating Controlled Affiliate’s compliance with the requirements of this Agreement including but not limited to the quality control provisions of this paragraph and the attached Exhibit A. D. Controlled Affiliate agrees that Plan and/or BCBSA may, from time-to-time, upon reasonable notice, review and inspect the manner and method of Controlled Affiliate’s rendering of service and use of the Licensed Marks and Name. E. As used herein, a Controlled Affiliate is defined as an entity organized and operated in such a manner, that it meets the following requirements: (1) A Plan or Plans authorized to use the Licensed Marks in the Service Area of the Controlled Affiliate pursuant to separate License Agreement(s) with BCBSA, other than such Controlled Affiliate’s License Agreement(s), (the “Controlling Plan(s)”), must have the legal authority directly or indirectly through wholly-owned subsidiaries to select members of the Controlled Affiliate’s governing body having not less than 50% voting control thereof and to: (a) prevent any change in the articles of incorporation, bylaws or other establishing or governing documents of the Controlled Affiliate with which the Controlling Plan(s) do(es) not concur; (b) exercise control over the policy and operations of the Controlled Affiliate at least equal to that exercised by persons or entities (jointly or individually) other than the Controlling Plan(s); and Notwithstanding anything to the contrary in (a) through (b) hereof, the Controlled Affiliate’s establishing or governing documents must also require written approval by the Controlling Plan(s) before the Controlled Affiliate can: (i) change its legal and/or trade names; (ii) change the geographic area in which it operates; (iii) change any of the type(s) of businesses in which it engages; (iv) create, or become liable for by way of guarantee, any indebtedness, other than indebtedness arising in the ordinary course of business; (v) sell any assets, except for sales in the ordinary course of business or sales of equipment no longer useful or being replaced; (vi) make any loans or advances except in the ordinary course of business; (vii) enter into any arrangement or agreement with any party directly or indirectly affiliated with any of the owners or persons or entities with the authority to select or appoint members or board members of the Controlled Affiliate, other than the Plan or Plans (excluding owners of stock holdings of under 5% in a publicly traded Controlled Affiliate); (viii) conduct any business other than under the Licensed Marks and Name; (ix) take any action that any Controlling Plan or BCBSA reasonably believes will adversely affect the Licensed Marks and Name. In addition, a Plan or Plans directly or indirectly through wholly owned subsidiaries shall own at least 50% of any for-profit Controlled Affiliate. (2) A Plan or Plans authorized to use the Licensed Marks in the Service Area of the Controlled Affiliate pursuant to separate License Agreement(s) with BCBSA, other than such Controlled Affiliate’s License Agreement(s), (the “Controlling Plan(s)”), have the legal authority directly or indirectly through wholly-owned subsidiaries to select members of the Controlled Affiliate’s governing body having more than 50% voting control thereof and to: (a) prevent any change in the articles of incorporation, bylaws or other establishing or governing documents of the Controlled Affiliate with which the Controlling Plan(s) do(es) not concur; (b) exercise control over the policy and operations of the Controlled Affiliate. In addition, a Plan or Plans directly or indirectly through wholly-owned subsidiaries shall own more than 50% of any for-profit Controlled Affiliate.

  • Management Plan The Management Plan is the description and definition of the phasing, sequencing and timing of the major Individual Project activities for design, construction procurement, construction and occupancy as described in the IPPA.

  • Site Control In the total loss of building use scenario, what likely exists will be a smoking pile of rubble. This rubble will contain many components that could be dangerous. It could also contain any personnel on the premises at the time of the disaster. For these reasons, the local fire marshal with the assistance of the police will control the site until the building is no longer a threat to surrounding properties and the companies have secured the site from the general public. During this time, the majority owner of the building should be arranging for a demolition contractor to mobilize to the site with the primary objective of reaching the cable entrance facility for a damage assessment. The results of this assessment would then dictate immediate plans for restoration, both short term and permanent. In a less catastrophic event, i.e., the building is still standing and the cable entrance facility is usable, the situation is more complex. The site will initially be controlled by local authorities until the threat to adjacent property has diminished. Once the site is returned to the control of the companies, the following events should occur. An initial assessment of the main building infrastructure systems (mechanical, electrical, fire and life safety, elevators, and others) will establish building needs. Once these needs are determined, the majority owner should lead the building restoration efforts. There may be situations where the site will not be totally restored within the confines of the building. The companies must individually determine their needs and jointly assess the cost of permanent restoration to determine the overall plan of action. Multiple restoration trailers from each company will result in the need for designated space and installation order. This layout and control is required to maximize the amount of restoration equipment that can be placed at the site, and the priority of placements. Care must be taken in this planning to ensure other restoration efforts have logistical access to the building. Major components of telephone and building equipment will need to be removed and replaced. A priority for this equipment must also be jointly established to facilitate overall site restoration. (Example: If the AC switchgear has sustained damage, this would be of the highest priority in order to regain power, lighting, and HVAC throughout the building.) If the site will not accommodate the required restoration equipment, the companies would then need to quickly arrange with local authorities for street closures, rights of way or other possible options available.

  • Quality Control Program Engineer shall have a quality control program in place that ensures that all deliverable work is of high quality. Engineer shall submit a plan detailing its program to the Inspection Branch of the TxDOT Bridge Division for review and approval prior to beginning work. State may review or audit the programs.

  • Project Management Plan 3.2.1 Developer is responsible for all quality assurance and quality control activities necessary to manage the Work, including the Utility Adjustment Work. Developer shall undertake all aspects of quality assurance and quality control for the Project and Work in accordance with the approved Project Management Plan, Good Industry Practice and applicable Law. 3.2.2 Developer shall develop the Project Management Plan and its component parts, plans and other documentation in accordance with the requirements set forth in Section 1.5.2.5

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