Open: 100% | Closed: 0%
Final Report Released On: July 06, 2023
2021-02-I-WV-5
Develop and implement a comprehensive process knowledge management program or evaluate and revise existing process safety management procedures to ensure consistency with industry guidance publications such as the Center for Chemical Process Safety’s Guidelines for Risk Based Process Safety. The program should:
a) assign specific responsibilities for compiling content and maintaining robust process technology and safety information packages that incorporate relevant knowledge for all hazardous processes and substances operated, manufactured, and/or handled by Clearon Corporation;
b) ensure that key process personnel are aware of critical reactive chemistry information, including thermal stability and calorimetry data, chemical compatibility information, and descriptions of any past reactive incidents and safety studies involving the materials; and
c) define procedures for the transmittal of such information to toll manufacturers.
Status:
Open - Unacceptable Response/No Response Received
Open - Unacceptable Response/No Response Received (O - UR) - Recipient responds by expressing disagreement with the need outlined in the recommendation. The Board believes, however, that there is enough supporting evidence to ask the recipient to reconsider.
Recommendation Status Change Summary
2021-02-I-WV-6
Update the sodium dichloroisocyanurate dihydrate (CDB-56®) safety data sheet. At a minimum, the document should:
a) provide the underlying reasoning for the storage temperature maximum and the consequences of exceeding that temperature;
b) provide the underlying reasoning for the decomposition temperature and the consequences of exceeding that temperature;
c) explain or make clear the reason(s) for and/or the circumstance(s) resulting in the differences between the decomposition temperature and the lowest temperature at which self-accelerating decomposition may occur; and
d) provide the exothermic decomposition energy in the Physical Properties section.
Status:
Open - Unacceptable Response/No Response Received
Open - Unacceptable Response/No Response Received (O - UR) - Recipient responds by expressing disagreement with the need outlined in the recommendation. The Board believes, however, that there is enough supporting evidence to ask the recipient to reconsider.
Recommendation Status Change Summary
2021-02-I-WV-7
Develop and implement a written program for tolling process design and equipment selection using resources such as the Center for Chemical Process Safety’s Guidelines for Process Safety in Outsourced Manufacturing Operations and Guidelines for Risk Based Process Safety to ensure that:
a) equipment design basis is adequate for any new tolling process or product; and
b) safeguards and ancillary equipment are considered and adequately designed, installed, and function as designed and required.
Status:
Open - Unacceptable Response/No Response Received
Open - Unacceptable Response/No Response Received (O - UR) - Recipient responds by expressing disagreement with the need outlined in the recommendation. The Board believes, however, that there is enough supporting evidence to ask the recipient to reconsider.
Recommendation Status Change Summary
2021-02-I-WV-8
Develop and implement a formalized program for the development of toll manufacturing agreements using resources such as the Center for Chemical Process Safety’s Guidelines for Process Safety in Outsourced Manufacturing Operations and Guidelines for Risk Based Process Safety. Ensure that the program provides for the following:
a) Identification of roles and responsibilities of all parties, including the client, toller, and any third-party technical service providers, for all phases of a proposed arrangement;
b) Evaluation of equipment requirements/specifications to ensure that they are adequate for the intended operation; and
c) Participation by all parties in tolling process development, including process hazards analysis and emergency planning, and appropriate stages of the pre-planning, pre-startup, and production phases.
Status:
Open - Unacceptable Response/No Response Received
Open - Unacceptable Response/No Response Received (O - UR) - Recipient responds by expressing disagreement with the need outlined in the recommendation. The Board believes, however, that there is enough supporting evidence to ask the recipient to reconsider.
Recommendation Status Change Summary
2021-02-I-WV-9
Develop and implement a process safety management system consistent with industry guidance publications such as is contained in the Center for Chemical Process Safety’s Guidelines for Risk Based Process Safety. At a minimum, the process safety management system should address hazard identification, risk analysis, and management of risk.
Status:
Open - Unacceptable Response/No Response Received
Open - Unacceptable Response/No Response Received (O - UR) - Recipient responds by expressing disagreement with the need outlined in the recommendation. The Board believes, however, that there is enough supporting evidence to ask the recipient to reconsider.
Recommendation Status Change Summary