Statistical process control programs

Use a statistical process control (SPC) computer software monitoring and control program to improve the record keeping and results trend analysis. 

Testing is not just executing a program using a test data file or randomly selected test cases just prior to implementation. It is an on going process using techniques based on Statistical Process Control (SPC) principles and product quality concepts implemented as components of a Statistical Quality Control (SQC) program.f ... 

In general, there should be more use for SPC (statistical process control) in the laboratory. With the current commercial software programs it is easy to get the data directly from the equipment. SPC is a simple universal useful tool for monitoring data, enabling early recognition of errors and failures and observing trends. The point is that you get much more information, besides just statistical data such as relative standard deviations and mean values. 

Standard interfaces with analytical equipment Monitoring of out-of-specification results using user-programmed limits on a per sample basis Import/export of data to/from spreadsheets Statistical process control Status of materials Tracking of samples... 

These new challenges in statistical process control have motivated the laxmch of quality control-oriented topics within several international research funding programs. For example, within the European Community 7th Framework Program, the topic zero defect manufacturing has generated calls for proposals in recent years. 

Quality assurance (QA) program for analyzer and sample system This is closely related to the control chart concept. The capability of the analyzer (e.g., accmacy, reproducibiHty, etc.) and the sample system (e.g., temperatme, pressure, flow, etc.) should be estabHshed as soon as possible after installation. The control charts (mentioned above) of statistical process control technique should indicate the capabilities of the analyzer system. The analyzer should be checked against a calibration... 

Sample system training The technicians should be familiar with the entire sample transportation and conditioning system. Several key questions should be asked Where does the sample come from and return Under what specific operating parameters, such as temperature, pressure, flow rate, should the sample system be operated How to monitor the system performance and how to isolate the sample system from process for offline service How to safely take a representative sample for offline analysis With a QA program and use of the statistical process control, the technicians should be trained to determine when to service the sample system, such as water wash to clear the sample line and when to replace some parts, such as a dirty Alter. 

Control of the raw material constituents is critical to the reproducibility and ultimate performance of thick-film products. Traceability of each of the components and the intermediates is imperative for the quality control function in order to comply with the high standards of lSO-9000 and continuous improvement programs. Routing equipment calibration programs, vendor audits, and utilization of statistical process control techniques are also necessary to... 

Variation is the fluctuations that can occur based on inconsistent environmental, human actions, equipment, tools, etc. Fluctuations of injuries and behaviors occur due to these variations in actions and conditions in the workplace. The statistical process control (SPC) (used in quality management) can aid in the review of injuries and observations, the organization can show the variations in its system. The SPC show whether the system is out of control and needs specific issues addressed or if it is in control but requires major across the broad safety program improvements (Daniels and Daniels, 2004 Deming, 1986). 

Process validation will be seen as a QA tool because it fits into the functions that QA performs. Process validation also benefits from the QA efforts of the other technical units in the company, however. Gershon [34] discussed Denting s concept of TQM and indicated that it consists of three phases. First, a cultural environment must be developed within an organization. Second, SPC fundamentals must be put into place. Third, statistics must be used to develop process controls and to assist management in running complex processes in an optimal manner. Revalidation thus fits very well in the company s TQM program. 

The bottom line is that most process validation teams should include or have access to a statistics expert. Because SPC offers many opportunities to improve costs and quality through trend analyses and control, SPC is recommended as a measure to be considered in any process validation program. 

Blaivas (B4) described the use of an IBM-1710 process-control system, on-line to 20 AutoAnalyzers, in which the computer program included instructions for the acceptance or rejection of standard curves, and a series of checks for monitoring the acceptability of values obtained for control sera. Any results that failed to meet the requisite criteria were indicated within a few seconds of the charting of a peak by a message typed on an on-line typewriter. This system has the ability to include daily statistical assessments of the quality of results, but these possible additional control features were not listed in the description (B4). 

The functions now realized by microprocessors include the control of the optical system (lamp and analytical wavelength selection), selection of the kind of data collected (e.g., absorbance, concentration), zero-adjustment, autocalibration and control of measurement parameters [21]. The microprocessor determines the equation of the regression curve and provides statistical processing of the results. It can also be programmed to measure the absorbance, the % transmittance at a selected wavelength, or the concentration based on the relationship (linear or non-linear) established between the measured absorbance and the concentration. 

The laboratory should have a systematic quality control program for checking or monitoring the reliability or accuracy of its results for all methods and measurement processes. As the standard covers more than residue testing laboratories, the particular quality control schemes and statistical techniques will vary according to the... 

The main purpose of the process optimization program is to identify the reaction parameters that would provide the best possible yield and quality in each step. To achieve quality and yield repeatably and reproducibly, planned optimization process parameters and strict controls on critical operating parameters are a must in each step of the process. Process optimization is done by using either the traditional one-at-a-time approach or statistically designed experiments, depending on the nature of interactions between parameters. This is ensured by smdying each key parameter involved in any reaction and identilying the optimal conditions. The parameters that are always studied are ... 

Quality control consists of sustaining the level of performance or quality as assessed over a. selected time period. The explanation of the concepts of quality control is often based on an industrial production process in which the quality can be or has been assessed by independent evidence perhaps of a specialized and more costly nature than the control testing that is to be established. Thus the state of statistical control as defined below is guaranteed by this independent evidence. Once this is in place, the operations to set up a control operation are straightforward. However in a laboratory setting independent evidence for a state of control may or may not be available. When it is not available, the process of establishing a bona fide quality control program must proceed by an iteration process. 

---