Tasks requiring written procedures

To determine which procedures must be written for a given job, you must first determine the tasks performed in that job. Although there are many different ways to identify tasks (refer to Appendix C, How to Determim Tasks That Require Written Procedures), most of these methods have six common steps ... 

HOW TO DETERMINE THE TASKS THAT REQUIRE WRITTEN PROCEDURES... 

There are different resources for identif5dng and selecting tasks that will require written procedures. Training Needs Assessments, Process Hazards Analyses, and Job Safety Analyses can assist you in analyzing the specific requirements of your plant. 

Anyone involved in writing analytical procedures and methods for the first time generally underestimates the difficulty of the task until faced with the results of an unsuccessful transfer process. Why is it then that we have a dearth of guidelines for such a task The major texts on analytical chemistry and analytical science do not contain such advice. Even recent books on the validation of analytical methods, The Approved Text to the FECS Curriculum of Analytical Chemistry and Quality Assurance in Analytical Chemistry, excellent though they are in other areas, make cursory reference, if any, to the requirements for good detailed written procedures. 

The CGMPs require that production procedures be written for any support activity that is repeated within a CGMP environment (21 CFR Subpart F-Production and Process Controls, Written procedures deviations ). Why is this true Simply because validation is about proving that something performs the same task in a consistent manner. Validation requires consistency. Likewise, procedures that are followed assure consistency. It should therefore be no surprise that operational procedures are written and executed repeatedly. The ultimate test for the validity of written procedures is the acceptability of the final, validated product. 

Evaluate each task to determine if the task will require a written procedure. Factors that determine if a task requires a written procedure can be the frequency, criticality, and complexity of performing the task. Other factors can include regulatory requirements such as the OSHA 1910.119 Process Safety Management Rule procedure requirements. For example, starting a simple pump may not require a written procedure because it is a very simple task that people are trained to do from memory. However, starting a compUcated pump with many auxiliary systems or a pump that is critical to safety may require a written procedme to ensure the pump is always started correctly. 

The organization s practices, which may or may not have been changed, have to be documented to meet the requirements of ISO 9000. The emphasis should be on simplicity, and the resultant system of procedures, instructions, forms, specifications, and so on should be designed with the user in mind. The user is the person doing the individual task or job. Excessive bureaucracy should be firmly eliminated. In many cases, the flow chart may be used to analyze work flows and map processes as well as replace complex written procedures. For a very detail explanation about documentation, see Ref. 5. 

As in all preventive maintenance programs, we must write procedures required for each PM task. Steps or procedures must be written for each task, and they must be accurate and understandable by aU maintenance personnel from entry level to master. 

The contractors SSAHPs at Sites B, F, and K had general confined space provisions but lacked site-specific confined space procedures. For example, SSAHPs for the Site K contractor and subcontractor had written confined space entry programs, but the programs did not establish site-specific rescue procedures or identify the confined space hazards present on the site. The job hazard analyses for both programs failed to address site maintenance tasks that could involve confined space entry and hot work hazards. The programs also failed to identify the specific person or position responsible for supervising confined space entry procedures and the location of permit-required confined spaces on site. Interviews with both contractors indicated confusion about rescue procedures. 

Together, the defined/written series of tasks, test methods, requirements and docnmentation required to carry out the validation procedure for a system can be described as the validation protocol. The instrnc-tion mannal for all of this is the validation plan, developed by the validation team. 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

Standard operating procedures will be required as written instruction to operating personnel on how to operate the manufacturing process. These will cover operation in conjunction with the computer system and also any tasks that are independent of the computer system. Where there is a requirement for quality-critical data to be manually entered on the computer system, there should be an additional check on the accuracy of the entry. If the computer system is not designed to carry out and record this check, then the relevant SOP must include this check by a second operative. 

Safety— Written operating and maintenance procedures provide information on hazards and the actions required to mitigate them. Lessons learned from incidents can also be included in the procedures when apphcable. This book describes how to alert users of hazards before performing a task. 

Generally, written operating and maintenance procedures are required by sound business practices or government mandate. Effective procedures provide written, dear instmction to the employee concerning how a task is safely and correctly performed. This helps to ensure that a task is performed with consistency regardless of the e q>erience level of the employee. 

You often identify critical, difficult, or hazardous tasks as part of a Process Hazards Analysis (PHA). PHA information is another resource used to indicate which procedures need to be written. The PHA also directs you to tasks that may require much more detailed procedures or training because of criticahty or safety issues. 

Since every laboratory operation differs in detail, safety personnel cannot be expected to prepare a written plan for each facility. For example, a research university is likely to have a thousand or more different laboratories. Attempting to draft a separate plan for each laboratory is far too big a task for most safety departments. It is reasonable, however, to expect a safety professional to design a standardized template and help the laboratory manager develophis own plan and written operational procedures. Even this effort will require a major effort for both the... 

HCF procedure development maintains consistency by follow/ing the TA-V Nuclear Facilities Conduct of Operations Manual (SNL 1998a) and the SNL ES H Manual (SNL 1998b). These documents describe procedure format and content, including Purpose, Scope, Ownership, Responsibilities, Definitions and Acronyms, Hazard Identification, Equipment and Materials, Format, Review and Approval Authority, and Document Control. Use of this format complies with DOE Order 5480.19, Conduct of Operations, Chapter 16 (DOE 1990). TA-V Standard Operating Procedures are written for tasks specifically identified in the Technical Safely Requirements (TSR) or as required by other directives or the SNL ES H manual to address special hazards. TA-V document types and hierarchy is described in TA-V Nuclear Facilities Conduct of Operations Manual (SNL 1998a) Chapter 16. 

Employers having employees who are at risk of bloodborne pathogens exposure are required to prepare a written exposure control program. The plan must evaluate routine tasks and procedures in the workplace that involve exposure to blood or other potentially infectious materials (OPIM) identify workers performing such tasks and use a variety of methods to reduce the risks. 

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