ASME BPE-2009 pdf download

ASME BPE-2009 pdf download.Bioprocessing Equipment.
GR-4.1 Inspector’s Delegate Inspector’s Delegate qualifications shall be in accor- dance with the requirements listed herein. The employer ofthe Inspector’s Delegate shall have documented train- ing and qualification programs to ensure the qualifica- tions and capabilities of personnel are met. The capabilities requirements are listed in Table GR-1. It is required that a capability listed for a lower level of qualification is also required for subsequent higher lev- els of qualification. GR-4.1.1 Levels ofQualification. There are four lev- els ofqualificationfor Inspector’s Delegate. Examination personnel qualifications are not covered in this section but shall be in accordance with ASME B31.3, para. 342. (a) Trainee. An individual who is not yet certified to any level shall be considered a trainee. Trainees shall work under the direction of a certified Quality Inspector Delegate and shall not independently conduct any tests or write a report of test results. (b) Quality Inspector Delegate 1 (QID-1). This individ- ual shall be qualified to properly perform specific cali- brations, specific inspections, and specific evaluations for acceptance or rejection according to written instruc- tions. A QID-1 may perform tests and inspections according to the capabilities’ requirements under the supervision of, at a minimum, a QID-2. (c) Quality Inspector Delegate 2 (QID-2). This individ- ual shall be qualified to set up and calibrate equipment and to interpret and evaluate results with respect to applicable codes, standards, and specifications. The QID-2 shall be thoroughly familiar with the scope and limitations of the inspection they are performing and shall exercise assigned responsibility for on-the-job training and guidance of trainees and QID-1 personnel. A QID-2 may perform tests and inspections according to the capabilities requirements.GR-2 SCOPE This Standard deals with the requirements of the bio- processing, pharmaceutical, and personal care product industries as well as other applications with relatively highlevels ofhygienic requirements, coveringdirectlyor indirectly the subjects of materials, design, fabrication, pressure systems (vessels and piping), examinations, inspections, testing, and certifications. Items or require- ments thatare notspecificallyaddressed in this Standard cannot be considered prohibited. Engineering judg- ments must be consistent with the fundamental princi- ples of this Standard. Such judgments shall not be used to overrride mandatory regulations or specific prohibi- tions of this Standard. GR-3 INSPECTION The inspection requirements are specified in each Part of this Standard. If an inspection or examination plan is required, it shall be developed and agreed to by the owner/user, contractor, inspection contractor, and/or engineer ensuring that the systems and components meet this Standard. GR-4 INSPECTOR/EXAMINER Inspector and examiner in this Standard shall be defined for the following: (a) Pressure Vessels. Authorized Inspector, as defined in ASME BPVC, Section VIII, Division 1, para. UG-91. (b) Piping, Tubing, and Non-Code Vessels. Owner’s inspector, as defined in ASME B31.3, paras. 340.4(a) and (b). Inspector’s Delegate, as defined in GR-10, meets the additional requirements listed in GR-4.1.
GR-4.1.2 Qualification Requirements. The qualifica- tion requirements listed herein shall be met prior to consideration for examination/certification. (a) Trainee (1) be a high school graduate or hold a state or military approved high school equivalency diploma (2) receive a minimum of 8 hr of relevant docu- mented training (total: 8 hr), including as a minimum the requirements shown in Table GR-1 (b) QID-1. To be considered as a QID-1, personnel shall meet the following: (1) be a trainee for a minimum of 6 mo of docu- mented relevantindustryexperience. Alternate methods for meeting the work experience requirement are at least one of the following: (a) prior or current certification as a QID-1 (b) completion with a passing grade of at least 2 yr of engineering or science study in a university, college, or technical school (c) possess an AWS-CWI certificate 1 or ACCP Level II VT certificate 2 or international equivalent (d) 2 yr of documented relevant experience in inspection, examination, or testing activities (2) receive a minimum of 16 additional hours of relevant documented training (minimum total p 24 hr), including as a minimum the requirements shown in Table GR-1 (3) pass a written test and practical performance examination, including as a minimum the requirements shown in Table GR-1 for this level