Procedures control

Closely related to tliese experimental approaches are optimal control procedures, in which one simulates... 

Manufacturing, analytical, and quaUty control procedures are thus estabhshed. Specifications for taw and in-process materials, as well as for final products per USP/NF and in-house standards are also determined. Process and formula vaUdation assures that each technological procedure in manufacture accomplishes its purpose most efficiently, eg, blending times for powdered mixtures in tableting, and that each formula ingredient is present in optimal concentrations (12). Thus, it serves to ensure process control (qv), reproducibiUty, and content uniformity. 

Analytical methods iaclude thin-layer chromatography (69), gas chromatography (70), and specific methods for determining amine oxides ia detergeats (71) and foods (72). Nuclear magnetic resonance (73—75) and mass spectrometry (76) have also been used. A frequentiy used procedure for iadustrial amine oxides (77) iavolves titratioa with hydrochloric acid before and after conversion of the amine to the quaternary ammonium salt by reaction with methyl iodide. A simple, rapid quaHty control procedure has been developed for the deterrniaation of amine oxide and unreacted tertiary amine (78). 

The other analytical methods necessary to control the typical specification given in Table 5 are, for the most part, common quality-control procedures. When a chemical analysis for purity is desired, acetylation or phthalation procedures are commonly employed. In these cases, the alcohol reacts with a measured volume of either acetic or phthalic anhydride in pyridine solution. The loss in titratable acidity in the anhydride solution is a direct measure of the hydroxyl groups reacting in the sample. These procedures are generally free from interference by other functional groups, but both are affected adversely by the presence of excessive water, as this depletes the anhydride reagent strength to a level below that necessary to ensure complete reaction with the alcohol. Both procedures can be adapted to a semimicro- or even microscale deterrnination. 

Quality assurance programs are designed to serve two functions (1) assessment of collected air quality data and (2) improvement of the data collection process. These two functions form a loop as air quality data are collected, procedures are implemented to determine whether the data are of acceptable precision and accuracy. If they are not, increased quality control procedures are implemented to improve the data collection process. 

Identification of wastes analytical control procedures labelling of containers Segregation of wastes identification of hazards due to inadvertent mixing of wastes... 

As a general rule, contamination control procedures depend on... 

D. Task-specific hazard analyses must lead to the development of written standard operating procedures (SOPs) that specify the controls necessary to safely perform each task. Detailed hazard analyses conducted for each site task and operation provide the basis for developing SOPs to protect employees from safety and health hazards. Written SOPs provide a mechanism for informing employees of procedures that ensure their safety and for enabling management to enforce hazard control procedures. 

Forty-hour training was required for personnel entering the exclusion zone, and additional supervisory training was required for site supervisors. Site control procedures described in the Site C contractor s SSAHP included maintenance of site control logs at each access point, use of red tape or chainlink fencing to demarcate hot zones, and use of the buddy system in all exclusion and contamination reduction zone areas. Site communications relied almost exclusively on visual sighting of employees the plan did not describe the use of two-way radios. This suggested that all employees in hot zones can be observed continuously from the support zones. 

Signiflcant deficiencies in site control procedures existed at Site K. For example, the Site K subcontractor had not established a contamination reduction zone (CRZ), to physically separate the support zone from the exclusion zone, as required in the site plan. 

The primary contractor at Site A had identified clean zones, buffer zones, and related site control procedures in its written plan however, onsite implementation differed from those specified in the plan. For example, the exclusion zones identified in the plan at the upper pad of the wastewater treatment plant, the dredge area, and the solid waste storage area were marked with signs requiring PPE, but were not labeled with red banners as called for in the plan. In addition, the exclusion zones did not have controlled access through one point of entry as described in the plan, nor were the buffer zones established and demarcated with yellow banners. 

Does the SAHP contain a lockout/tagout program that includes energy control procedures and employee training practices [OSHA Reference. 147(c)(1)]... 

The standard does not require you to document how you maintain your quality policy but the requirements of clause 4.5.1 place the quality policy into the category of documents which need to be governed by documented control procedures and hence all changes must be reviewed and approved. 

Operational policies, structured to align with the sequence of key processes from receipt of customer inquiry through to delivery and after-sales support, referencing the implementing control procedures... 

Control procedures control work on product as it passes between departments or processes. These should contain the forms which convey information from department to department and reference the operating procedures that apply to each task. 

Work instructions define the work required in terms of who is to perform it, when it is to commence and to be completed, what standard it has to meet, and any other instructions which constrain the quality, quantity, delivery, and cost of the work required. Work instructions are the product of implementing a control procedure, an operating procedure or a document standard (see further explanation below). 

Identify the control procedures you need to control what you do now and prepare a document development plan. 

This general requirement for procedures introduces uncertainty into what particular procedures are actually required. The standard does not require the design control procedures to address each requirement of this clause but were they not to, you would need to demonstrate that the absence of such procedures had no adverse affect on the quality of design. 

Policies and practices (these include control procedures, guides, operating procedures, and internal standards)... 

The aspects you should cover in your document control procedures are as follows, some of which are addressed further in this chapter ... 

The production plan referred to previously is a work instruction, as it instructs those to whom it applies to carry out certain tasks. Control procedures may include assembly procedures, plating procedures, painting procedures, maintenance procedures, etc. and differ from process specifications (see later) in that the process specification defines the results to be achieved in operating a process rather than how to run the process. In addition to the list of contents provided in ISO/TS 16949 clause 4.9.2, the documentation should define ... 

The documents that define the calibration process themselves are derived documents and therefore will be governed by your control procedure. They do not need to be listed along with all your other control and operating procedures in the index of quality system documents. A separate index of calibration methods should be maintained. Calibration methods are like test and inspection procedures, they are product specific. 

In order to implement these requirements your nonconformity control procedures should include the following actions ... 

---