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Want to Learn More? Contact Us Today! Sign up. Already have an account? Log in. X ESHA Research uses cookies to improve the features of the site, analyze traffic, and to understand how users interact with our site. However, the same software may allow an operator to override the stop and reactivate the auger motor even at a weight that exceeds the set point limit. It is therefore important to know what overrides are allowed, if they conflict with the firm's operating instructions and how the system documents the override event s.
Software Development : During the inspection determine if the computer software used by the firm has been purchased as "off the shelf" from outside vendors, developed within the firm, prepared on a customized basis by a software producer, developed by a third party vendor or some combination of these sources.
Some software is highly specialized and may be licensed to food establishments. If the software used by the firm is purchased or developed by outside vendors, determine which firms prepared the software. Sometimes "off the shelf" or customized software may contain segments such as complex algorithms which are proprietary to their authors and which cannot normally be readily retrieved in program code without executing complex code breaking schemes.
In these cases the buyer should obtain validation documentation from the supplier to ensure that the software will perform as designed. If the food manufacturer is using such software to control or monitor a critical control point in the food process, determine what steps the firm has taken to verify that the software is performing as it was designed.
Where food firms develop their own application software, review the firm's documentation of the approval process. This approval process should be addressed in the firm's written development instructions. It may be useful to review the firm's development English documents that formed the basis of the computer software See Software Development Activities, July , U.
Software Security : Determine how the firm prevents unauthorized software changes and how data is secure from alteration, inadvertent erasures, or loss. The firm's security procedures should be in writing.
Security should also extend to devices used to store software, such as tapes and disks. Determine if accountability is maintained for these devices and if access to them is limited. An important part of software security is change control. The firm should have in place a written procedure by which changes are made to software.
This will include identification of a software error, how it was corrected, who performed the correction, did the changes influence any other portions of the software program, were the changes validated specifically and then as they related to other portions of the software program, and how the changes were documented. Software has a circular life-cycle that requires a defined maintenance procedure be followed See Computerized System Validation.
Personnel operating, maintaining and programming computerized control systems should have adequate training and experience for performance of their assigned duties. Determine the extent of operator, system managers, and computer system technical personnel training in the functions, requirements and operation of the computerized system.
Training should include not only system operation but cover the significance of system faults bugs , regulatory requirements, system changes, security procedures, manual operation of the system, and documentation of system errors.
Training of computerized system personnel should be documented by the manufacturing firm. The investigator should determine the key computerized system personnel during the inspection. This may include not only the firm's own employees but outside vendors or consultants. For each of the key employees, determine to the extent possible, that employee's responsibility for the computerized system.
It is important that technical personnel are available or can be reached during computerized system failures. Most computerized systems are capable of generating accurate and detailed documentation of the food process under computer control.
What is important is that the computer generated records contain all of the information required by the CGMPS. For example, if production records are generated by computer, determine if they contain all of the information required to be in each record s.
The firm should have security measures in place to insure that data captured by the computerized system cannot be altered. If provisions are made to allow correction of data entries, the entry should identify the person making the changes and the reason for the change should be identified.
For example an operator misreads a temperature indicator and enters the information into the system. The computer system then alarms the operator that the entry is out of the correct range. The operator then enters the correct temperature which is accepted by the system. All of the above should be captured on the firms records. For those firms storing records electronically, provisions should be made to store the records in a format which cannot be easily altered.
Electronic records must be maintained in a format that can be presented to the investigator in a readable form. This could be in the form of electronic data that can easily be accessed and read by common computer software or in the form of accurate hard copy documents produced from electronic records maintained by the firm.
Electronic Signatures if used should be controlled by the firm under written operating procedures, which insure that the electronic signature is a valid representation of the individual making the entry. Operator entry codes should be protected so that they can be used only by the person assigned that code. A computerized system includes: the computer hardware, computer software, peripheral devices, personnel, and computer system documentation including computer hardware and software manuals, specifications for peripheral devices and standard operating procedures.
The computerized system used to control critical functions in food processing should be validated in its entirety. The suitability of a computerized system for the tasks assigned to food production should be shown through appropriate tests and challenges.
The depth and scope of computerized system validation will depend upon the complexity of the system and its potential effect on food safety. The validation program need not be elaborate but should be sufficient to support a high degree of confidence that the computerized system software, hardware, personnel and operating procedures will consistently perform as it is supposed to See System Testing Reference "Software Development Activities Report.
Although various components of the computerized system may be tested separately qualification , the total computerized system should be validated. Validation requires the system, as it will be configured and used in production to be shown to behave as expected defined or specified not only for normal conditions and inputs, but importantly that it continues to provide control and useful, meaningful outputs when unusual, or unexpected conditions and events occur and when inputs occur at the specified ranges or boundaries.
That is, worst case conditions must be identified and tested. It is vital that a firm have assurance that software routines, especially those that control critical manufacturing functions, consistently perform as they are supposed to within pre-established operational limits.
Determine who conducted the computerized system validation and how key computerized system routines were tested. Computerized system vendors routinely perform an installation qualification to ascertain that the equipment is functioning within the hardware manufacturers specifications after being installed.
However, hardware qualification is only part of the verification process and the complete computerized system should be validated. The ultimate responsibility for suitability of the computerized system used in food processing rests with the food manufacturer.
Computerized system validation data and protocols should be kept at the food manufacturer's facility. When validation information is produced by an outside firm, such as the computer vendor or software developer, the records maintained by the food establishment need not be all inclusive of voluminous test data; however, such records should be reasonably complete including system specifications, protocols and general results to allow the food manufacturer to assess the adequacy of the system validation.
A mere certification of suitability from the vendor, for example, may be inadequate. The accuracy and performance of these devices are vital to the proper operation of the computer system.
Improper inputs from thermocouples, RTDs, pressure gauges, etc. These sensors should be systematically calibrated and checked for accurate signal outputs. Input to and output from the computer system should be checked by the processing firm for accuracy. While this does not mean that every bit of input and output needs to be checked, it does mean that checking must be sufficient to provide a high degree of assurance that input and output is accurate.
In this regard there needs to be some reasonable judgment as to the extent and frequency of checking based upon a variety of factors such as the complexity of the computer systems. The right kinds of input edits, for example, could mitigate the need for extensive checks. Determine the firm's error handling procedures including documentation, error verification, correction verification, and allowed error overrides. Failure of the firm to verify that the computer is providing an accurate reading of the correct temperature by independent observations of the Mercury-in-Glass thermometer during the thermal process would be a lack of adequate input checks.
Failure of the firm to respond in some way to differences between the recorded computer sensed temperature and the observed temperature would indicate inadequate error handling. Determine the degree to which the firm's personnel monitor computerized operations. Is such monitoring continuous or periodic, what functions are monitored?
For example, a firm's computer system may be used to maintain the pH in a mixing kettle, but if the firm does not sufficiently monitor the system they may fail to detect a hardware problem that allows the pH to go out of tolerance. During the inspection, where possible, spot-check computer operations such as:. Time keeping; where computers are reporting events and controlling a function in real time, spot-check the time accuracy against a separate time piece; accurate time keeping is especially important where time is a determinative or limiting factor in a food manufacturing process such as during pasteurization or sterilization.
It should be noted that some computer systems run on a hour clock whereas others run on a hour clock. When a host computer system is used, determine if the host or the process computer controls the time during process function control, record printing etc.
Time keeping conflicts can arise when more than one of the computers is responsible for keeping or indicating time. The firm should have a requirement for the computer clock to be reset at predetermined intervals to insure that the system is using the correct time of day. This may be important in continuously operating systems and in those systems documenting the production time of day. A typical computer system will have several built-in alarms to alert personnel to some out-of-limits situations or malfunctions.
Determine what functions are linked to alarms. For example, alarms may be linked to power supply devices, feedback signals to confirm execution of commands, and food process conditions such as empty or overflowing tanks.
Determine the alarm thresholds for control of critical functions and whether or not such thresholds can be changed by the operator. Determine how the firm responds when an alarm is activated.
This should be covered in the firm's written operating procedures. Determine the types of alarms lights, buzzers, whistles, etc. Are they tested periodically and equipped with in-line monitoring lights to show they are ready? Because an activated alarm may signal a significant out of control situation it is important that such alarm activations are documented.
Determine how alarms are documented in production records, in separate logs or automatic electronic recording, for instance.
Can all alarm conditions be displayed simultaneously or must they be displayed and responded to consecutively? If an employee is monitoring a CRT display covering one phase of the operation, will that display alert the employee to an alarm condition at a different phase? If so, how? The operation of the computerized systems alarms should be validated as part of the complete computerized system under actual operating conditions.
Functions controlled by computerized systems may sometimes also be controlled by parallel manual backup systems. During the inspection find out what functions can be manually controlled and identify manual backup devices. Critical process controls are particularly important. Determine the interaction of manual and computerized controls and the degree to which manual intervention can override or defeat the computerized function.
The firm's operating instructions should describe what manual overrides are allowed, who may execute them, how and under what circumstances. Determine if and how manual interventions are documented; a separate log may be kept of such interventions.
The computerized system may be such that it detects, reacts to and automatically records manual interventions and this should be addressed during the inspection. It is important that system operators are trained in manual backup systems. Determine the extent of the operator training and if the firm has any procedures for testing the manual backup system on a routine basis e.
How a computer controlled function is handled in the event of computer shutdown e. Shutdown recovery procedures are not uniform in the industry.
Some systems, for example, must be restarted from the initial step in the software routine sequence and memory of what has occurred is lost. Other systems have safeguards whereby memory is retained and the control function is resumed at the point where it was halted.
Determine the disposition of the computer's memory content program and data upon computer shutdown. Determine the firm's shutdown recovery procedure and if, in the event of computer failure, the food manufacturing process or control function is brought into a "safe" condition to protect the product. Determine such safeguards and how they are implemented. Where is the point of restart in the cycle - at the initial step, a random step or the point of shutdown? Look for the inappropriate duplication of steps in the resumption of the process.
The time it takes to resume a computerized process or switch to manual processing can be critical, especially where failure to maintain process conditions for a set time e. Therefore, note recovery time for delay-sensitive functions and investigate instances where excessive delays compromise product safety or where established time limits are exceeded. Many systems have the ability to be run manually in the event of computer shutdown.
It is important that such backup manual systems provide adequate function control and documentation. Determine if backup manual controls valves, gates, etc.
Records of manual operations may be less detailed, incomplete, and prone to error, compared to computerized documentation, especially when they are seldom exercised. Therefore, determine how manual operations are documented and if the information recorded manually conforms with CGMP requirements. The computerized systems shutdown and recovery process should be validated as part of the validation of the computerized system under actual operating conditions.
Software Development Activities Report, Feb. The guide should not be used without a through understanding of the information provided in the main text of the Guide To Inspection of Computerized Systems in the Food Processing Industry. Examples would be:. For those critical control points controlled by computerized systems determine if failure of the computerized system may cause food adulteration. Obtain or make a simplified drawing of the computerized system control loop including:.
Determine if the operator or management can override computerfunctions. Determine the validation steps used to insure that the computerized system is functioning as designed. Are system components located in a hostile environment which may effect their operation?
Does the firm have a documented system for making changes to the computerized system which explains:. Document computer functions which are causing or may cause food products to be adulterated or misbranded. Return to: Page Top Inspection Start. The proposed requirements include: Definitions of hardware, software, system, and validation. Requirements that systems be designed, installed, tested and maintained in a manner that will insure that they are capable of performing their intended functions.
Requirements for system validation and calibration. Requirements for revalidation when system changes are made. Requirements for making and retaining records concerning electronic systems.
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