System safety program guidelines

Step 11 Seek management approval of system safety program guidelines... 

A system safety program documents the SMS. Table 4.6 is a sample SMS SSPP and is a best practice and practical compilation of the 29 SMS Elements OSHA Mil-Std-882C Consumer Product Safety Commission OSHA Voluntary Protection Programs nnmerous UK, European, and Anstralian national SMS guidelines and varions industry SMS SSPPs. Use all sections listed in the following. 

In 1985, the American Institute of Chemical Engineers (AIChE) initiated a project to produce the Guidelines for Hazard Evaluation Procedures. This document, prepared by Battelle, includes many system safety analysis tools. Even though frequently identified as hazard and operability (HazOp) programs, the methods being developed by the petrochemical industry to use preliminary hazard analyses, fault trees, failure modes, effects, and criticality analyses, as well as similar techniques to identify, analyze, and control risks systematically, look very much like system safety efforts tailored for the petrochemical industry (Goldwaite 1985). 

Other internationally recognized system guidelines to comprehensive safety programs, such as OHSAS 18001 and the ISO series, have already been mentioned in this book. 

The CCPS book Guidelines for Auditing Process Safety Management Systems provides guidance on developing PSM audit programs and conducting... 

With the support and direction of its advisory and management boards, CCPS established a multifaceted program to address the need for process safety technology and management systems to reduce potential exposures to the public, the environment, personnel and facilities. Over the past several years, CCPS has extended its publication program to include a "Concept Series" of books. These books are focused on more specific topics than the longer, more comprehensive Guidelines series and are intended to complement them. With the issuance of this title, CCPS has published 80 books. 

The Government of India has established the National GLP Compliance Monitoring Authority (India GLP), adopting the OECD quality system of the principles of GLP, for inspection, monitoring, and accreditation of test facilities in India for conducting nonclinical and environmental safety studies. Currently, India enjoys the full member status of OECD for GLP. India is a member of the OECD Test Guidelines program. 

The second component of a successful clinical manufacturing program is appropriate quality assurance systems for the production of cell or viral banks, raw materials, in-process materials, and final product. Much has been written about the production and testing of cell and viral banks for use in manufacturing. Both FDA guidelines and other reference information are available (http // www.fda.gov.cber/guidelines.htm http //www.ich.org, http //www. emea.eu.int). The production of AAV vector batches for use in clinical trials should use qualified cell, viral, and/or plasmid banks as appropriate. Documentation on the source materials for these banks is also crucial in assuring the quality and safety of the clinical trial materials. 

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