Engineering Change Control

Change Control will be written to ensure that systems and processes remain in a state of validation. The procedure outlines steps to follow when a change is proposed. The change control program ensures that proposed changes are reviewed and approved by appropriate departmental representatives prior to initiating changes. The review also defines the required tests and documentation to be performed to verify that the system, equipment, and process remain in a validated state. 

The calibration program will ensure that all critical instruments used are maintained in a calibrated state. Specific acceptance criteria limits will be established based on system and processing requirements. 

Periodic calibration orders generated by the calibration program will contain information such as department, location, accuracy, data sheet number, SOP number, etc. needed by the calibration technician. Instrumentation in this program will include, but is not limited to, timers, monitoring probes (temperature, relative humidity, etc.), pressure gauges, balances, etc. 

Each instrument will be placed in one of three categories Critical, Non-critical, and Convenience. A critical instrument is one whose failure or precision directly affects the quality, purity, and/or integrity of the product. A non-critical instrument does not fall into the Critical category, but can be used in troubleshooting, mainting, controlling, or monitoring 

Instrument calibrations are required at intervals based on the criticality of the instruments, instrument capability, and instrument calibration history. An instmment will also be calibrated following the repair of the instrument, following the repair of the system that the instrument is monitoring/controlling, if the repair could have affected the instrument accuracy, and/or after installing the instmment into a system. All equipment used to perform calibrations will be calibrated to standards traceable to the National Institute of Standards and Technology (NIST) or other approved standards and maintain the following  

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To make any changes in existing equipment configuration, parts, or software or in utilities (HVAC), facility systems, etc., the engineering change control form will be raised. 

Craven, P.J. (1999) Intelligent Control Strategies for an Autonomous Underwater Vehicle, PhD Thesis, Department of Mechanical and Marine Engineering, University of Plymouth, UK. Craven, P.J., Sutton, R. and Burns, R.S. (1997) Intelligent Course Changing Control of an Autonomous Underwater Vehicle. In Twelfth International Conference on Systems Engineering, Coventry, UK, September, 1, pp. 159-164. 

Traditional Safety Engineering approach (control of error by motivational, behavioral, and attitude change) Occupational safety Manual operations Selection Behavior change via motivational campaigns Rewards/punishment Very common... 

Thus, it is highly desirable that key buyers and sales channels have already been locked up by the time of product launch. Inevitably, customers, process engineers, financial officers, and other stakeholders request various design changes. Proper change control is essential to avoid unacceptable delays and cost overruns. 

Production engineer Process observations and geology Manufacturing scheduling Coordinates development within production Validation and change control management Operations... 

Currently, there are closure Resource Conservation Recovery Act (RCRA) permit modifications awaiting ERA approval. To date, there have been no delays due to approval of permit modifications, but they could occur in the future. Permit modifications need to be identified sufficiently early to allow time for regulatory reviews, public comment, resolution of comments, and incorporation of changes into the applicable engineering change proposals (ECPs), work orders, or other management control documents. 

Recommendation 9. The Army should develop an earned value system to maintain a comprehensive multiyear cost and schedule for the construction, operation, and closure of each chemical agent disposal facility. The system should be used to control and report the effect on cost and schedule from changes such as permit modifications, proposals for engineering changes, and the phaseout of security for surety material. 

In addition to inspection and calibration of instrumentation carried out as part of an SAT, the need for recalibration of critical instruments prior to IQ, OQ, and PQ should be reviewed and the decision documented in the respective qualification report. All site calibration activity should be conducted in accordance with quality standards and the respective engineering procedures. Any remedial work should be undertaken under document control, and where necessary, evaluated under change control. 

Abnormal operation—A failure occurs with the computer system or with the measurement and control instrumentation and an emergency repair is carried out either by site engineering or by the system supplier under the terms of the support agreement. In emergencies, immediate action may be authorized by the production department in conjunction with quality assurance, the problem, the action taken, and the updating of all affected documentation recorded retrospectively for change control assessment. 

Most firms today use a validation change control system, by which such documents as engineering work orders, revisions to standard operating procedures (SOPs), and proposed formulation order changes are reviewed by a committee of the same disciplines as those responsible for validation approvals. The objectives are to determine the potential impact on validation status before formally approving the change. This mechanism enables a firm to take immediate prospective action, obviating the need to revalidate the entire system. 

Chapter 17 deals briefly with the engineering process control, which primarily involves measurement of a product property and comparison to a desired value. The process operation can be thus immediately adjusted to reduce deviation from the specifications. This feedback procedure can be used to adjust the process whenever the product deviates from the set point and can be used to change operating points and to reject the effect of outside disturbances. 

Once the supplier is selected, collaboration with the pharmaceutical manufacturer s technical and validation groups is essential to the delivery of a well-engineered, validated system. Close cooperation is required to ensure the IPC functions match the URS and the demands of validation are accommodated within the project process. Following cutover, the validated status of the IPC system must be maintained through change control by the technical, FT, and validation groups. 

Associated project documentation used by other engineering disciplines is also essential, and it is important that an effective change control system is in place to communicate changes made to Engineering Lines Diagrams (ELDs/P IDs), I/O Schedules, and Process Descriptions. 

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