Written procedures importance

Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

This question refers to situations where the toller himself is carrying out cleaning operations at his own premises. Cleaning is a very important element of toller s effort to maintain quality. The assessor should read and check all written procedures carefully. 

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. 

Company has not conducted periodic quality assurance audits in accordance with written procedures. These procedures call for semi-annual until compliance is achieved and annual audits thereafter. The last quality assurance audit was conducted in 1996. Similar to the FD-483 observation above, this observation rose to the level of a warning letter citation because of the importance and requirement of an FDA-regulated company to employ a formalized quality assessment program. 

The IB should be reviewed at least annually and revised as necessary in compliance with a sponsor s written procedures. The revised version should be included in the IND annual report. More frequent revision may be appropriate depending on the stage of development and the generation of relevant new information. However, in accordance with GCP, relevant new information may be so important that it should be communicated to the investigators, and possibly to the IRBs and the FDA, before it is included in a revised IB. 

Despite overwhelming evidence suggesting that poor machinery lubrication spells trouble for the plant, most organizations lack clearly defined written procedures for performing basic lubrication tasks. The following outlines reasons why lubrication procedures are important elements of a proper lubrication procedure. ... 

Training— Written procedures are inextricably linked to operations and maintenance training. Well-written procedures provide a sohd means of meeting the need to train workers on safe operations and maintenance. This book describes why procedures are important training tools. 

Chapter 3 describes the importance of written procedures and how to design a system for guiding procedure development and revisions. This procedure management system works with Management of Change to ensure procedures are selected, developed, and reviewed consistently using a planned framework that allows their easy use and maintenance. 

The guidelines and regulations cited so far have focused on process safety. However, certification and award programs such as the International Organization for Standardization (ISO) Standard 9002, "Quality Systems— Model for Quality Assurance in Production and Installation," place heavy emphasis on quality management. Written procedures and document control are important factors for ensuring and maintaining quality, reliability, and consistency. 

Written procedures are an important part of Process Safety Management because they... 

Chemical manufacturers, importers, or employers evaluating chemicals shall describe in writing the procedures they use to determine the hazards of the chemical they evaluate. The written procedures are to be made available, upon request, to employees, their designated representatives, the Assistant Secretary and the Director. The written description may be incorporated into the written hazard communication program required under paragraph (e) of this section. 

Companies must have a written procedure that specifies the maximum number of retests. The SOP must define how retesting will be performed. It is understood that the investigation procedure cannot be fully pre-defined and depends on the problem and product. Instead, each testing step must be approved and supervised by a responsible person in the Quality unit. It is important that the retesting be performed... 

Method 3810 recommends that a sample be heated to 90°C and 2 mL of headspace gas taken with a gas-tight syringe. The written procedure for this method was published in SW-846 and provided no data on method performance at that time. The publication of a method from a regulatory agency without even a minimum of quality assurance and quality control is inexcusable This method serves as one example of neglected GLP. The importance of GLP was introduced in Chapter 1 and this neglect attests to the fact that little to no interest in static HS techniques existed back in 1986. 

Where possible, the written procedures should be supplemented with graphics. Not only do graphics provide additional information and explanation, they also make the manual more attractive. This is important because a manual that is attractive and easy to read is more likely to be used. The following types of graphics can be used ... 

OSHA s standard requires that The employer shall establish written procedures to manage changes— The principle involved here is important and is having its impact far beyond chemical companies. What is required is that hazards be identified and evaluated when changes are made in design criteria, operations, procedures, and facilities. That s a good thing to do, and I recommend a broad application of the principle. It is a concept that can be applied in all businesses and industries, as the top performers have learned. 

Maintenance that could either affect the performance of items important to safety or potentially endanger the health and safety of personnel should be preplanned, and should be performed in accordance with properly approved written procedures or drawings appropriate to the circumstances. However, no maintenance procedure should necessitate the bypass or removal from service of systems or components if this would result in the loss of one or more safety functions (see Ref. [6]). 

Records of replacement, modifications and maintenance of reactor components are also an important source of information to understand the effects of ageing. The records should show the methods of problem identification, analysis and solution. Preparation of reports should be based on a written procedure. 

Worker safety issues are important when handling any organic solvent. Written procedures that follow the MSDS guidelines are recommended for all workers who handle any of the aldehydes. Workers must remember that all of the... 

Worker safety issues are important when handling any organic solvent. Written procedures that follow the MSDS guidelines are recommended for all workers who handle any of the ester solvents. Workers must remember that all of the esters have flash points as listed in the physical property tables. The vapors which are heavier than air can travel considerable distance to an ignition source and flashback. The esters also create a special fire hazard because the solvents float on water. The use of carbon dioxide or dry chemical is recommended for small fires and alcohol-aqueous film-forming foam or water fog for large fires. Water may be ineffective but can be used to cool fire-exposed structures and vessels. All of the solvents have a limited flammability range... 

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