Quality system components

A key aspect of this quality process component is to evaluate if the people doing the job have access to and are following the established procedures. There should be a system to manage the updating of procedures, communicating the changes, and training personnel on the procedures. 

QRA practitioners can use to satisfy some QRA objectives. Also, the American Institute of Chemical Engineers (AIChE) has sponsored a project to expand and improve the quality of component failure data for chemical industry use. And many process facilities have considerable equipment operating experience in maintenance files, operating logs, and the minds of operators and maintenance personnel. These data can be collected and combined with industrywide data to help achieve reasonable QRA objectives. However, care must be exercised to select data most representative of your specific system from the wide range available from various sources. Even data from your own plant may have to be modified (sometimes by a factor of 10 or more) to reflect your plant s current operating environment and maintenance practices. 

A Btu meter may be used in the fuel-quality system as an aid in determining turbine system efficiency. A water capacitance probe is used for detection of water in the fuel line. A water-detecting device can be incorporated into the corrosion monitoring system. This monitoring device is based on detection of changes in the dielectric constant of unknown fluid components... 

The elements of a PM plan include periodic inspection, cleaning, and service as warranted, adjustment and calibration of control system components, maintenance equipment and replacement parts that are of good quality and properly selected for the intended function. Critical HVAC system components that require PM in order to maintain comfort and deliver adequate ventilation air include a outdoor air intake opening, damper controls, air filters, drip pans, cooling and heating coils, fan belts, humidification equipment and controls, distribution systems, exhaust fans. 

Next is a questionnaire which only covers the specific requirements of the standard. This breaks down the requirements into their individual components where it is likely that the solutions for each part will be different. It can be used as a basic checklist for verifying that the quality system you have designed addresses all the requirements, or as a means of creating policy or of assessing conformity. 

The elements of the system can be construed to be the 20 elements of ISO 9001. The components of the system are different. ISO 8402 states that a quality system is the organizational structure, procedures, processes, and resources for implementing quality management. It therefore follows that in reviewing the quality system one needs to review each of these aspects. 

A system is an ordered set of ideas, principles, and theories or a chain of operations that produces specific results to be a chain of operations, the operations need to work together in a regular relationship. A quality system is not a random collection of procedures (which many quality systems are) and therefore quality systems, like air conditioning systems, need to be designed. All the components need to fit together, the inputs and outputs need to be connected, sensors need to feed information to processes which cause changes in performance and all parts need to work together to achieve a common purpose i.e. to ensure that products conform to specified requirements. You may in fact already have a kind of quality system in place. You may have rules and methods which your staff follow in order to ensure product conforms to customer requirements, but they may not be documented. Even if some are documented, unless they reflect a chain of operations that produces consistent results, they cannot be considered to be a system. 

The requirement may not apply to all product acceptance decisions. If your acceptance of the end product does not depend upon acceptance decisions being made on its component parts, any sampling carried out on receipt inspection or in-process is not important to the product acceptance decision and can therefore be ignored in your documented quality system. This is a wise course of action if you can be sure this will always be the case but if you can t, and more often than not you won t know, it is prudent to encompass a//sampling activities in your quality system. 

Procedures for assurance of quality in the design, fabrication, installation, maintenance, testing and inspection for critical equipment are ) red. Safety requires that critical safety devices must operate as i led and process system components must be maintained to be able to contain design pressures. 

Describe (where possible) the production system components (e.g. crop or livestock health management practices, soil fertilisation methods, crop rotation designs, livestock feeding and husbandry regimes, crop varieties/livestock breeds used) responsible for differences in food quality and safety between production systems ... 

Quality control examinations shall include the requirements of the construction organization s Quality System Program for materials, products, components, workmanship, quality documents, procedures and personnel qualifications, construction, and subcontract services. 

Water and particulates are the source of fuel quality problems such as filter plugging, corrosion, and system component fouling. Water can be removed through salt drying, coalescence, filtration, and good housekeeping. 

A key component in any quality system is appropriately responding to nonconformities (i.e., deviations from requirements established under the quality system for in-process material or final product quality attributes, process control parameters, records, procedures, etc.). Nonconformities may be detected during any stage of the... 

The evaluation component of a QMS is intended to provide objective information and data that allow the organization to assess the conformity of the product, evaluate the performance of its quality system, and maintain and improve its effectiveness [10]. The cGMP regulations similarly require evaluation activities as shown in Table 4. 

A corrective action is initiated to correct the cause of an identified nonconformity and to prevent it or similar problems from reoccurring. It may include initial and follow-up actions (e.g., conducted after root cause analysis). Current quality system models and the cGMP regulations emphasize corrective actions and require that actions be documented. Under current quality system models, preventive actions include actions taken in response to quality data to address the cause of potential nonconformities to prevent their occurrence. An effective CAPA system therefore includes both reactive and proactive components. The effectiveness of corrective and preventive actions should be evaluated using objective criteria when possible and the evaluation documented. 

Furthermore, the ISPE Baseline Guide, Commissioning and Qualification [5] emphasises the need to undertake qualification practices only for equipment and system component parts and functions that could directly impact quality attributes of a product or process. Other components and functions are to be dealt with under good engineering practice (GEP) [3,5] throughout the system life cycle, undergoing an appropriate level of documented commissioning. 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

Calibration of critical instruments and system components must be controlled by a calibration schedule in order for call-off dates to be determined. The calibration periodicity should be determined by the process owner, its quality representative, and the maintenance engineer, taking into account the manufac-... 

The primary FDA regulations apphcable to medical device product software are 21 CFR 820.70(i), 21 CFR 820.30 and all of the CPGs discussed in this chapter. Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer s quality system. According to 21 CFR 820.70(i) the automated system must be qualified for its intended use to ensure system... 

It is the practice of organizations performing operations in a regulated environment to work proactively with computer technology suppliers and contract developers, to ensure that the system components conform to the quality requirements defined by each organization. 

---