All organizations must have Safety SOP and/or instructions and many organizations conduct validations of new apparatus, processes and methods, including, in tenders. In practice however, not enough attention is given to the observance of safety rules during the validation and accordingly, these issues are not addressed properly during the preparation of a validation protocol. Unfortunately, it is very common to see the following phrase under the Safety section of the validation protocol: Execution of works should be conducted in accordance with applicable organization Safety SOP and/or instructions (which usually do not say anything about validation). This is a typical example of a formal and an unacceptable approach to safety issues.
There are 4 main reasons why there must be special attention to safety issues during validations of new apparatus, processes and methods:
- There is use of new, unfamiliar materials and methods.
- The validation work is regarded as a temporary, one-time job.
- A desire by the administration (and the employee) to complete the validation as soon as possible which is often conducted as additional (or even unpaid) work.
- No appropriate financial and engineering support for safety, especially when it requires significant costs.
The best way to mitigate these issues, it is necessary to include in the Safety SOP a section called “Safety validation of new equipment, processes and techniques“, where you can focus on the following provisions:
- In preparation for the validation, the safety protocol should be extensively elaborated, as it often deals with unfamiliar machines, materials and methods of work.
- The main sources of information about safety in the preparation of validation protocols are sections Safety, Warning and Precautions in manufacturer’s operating instructions, Material Safety Data Sheets (MSDS), and appropriate regulatory documents.
- During the preparation of the validation, take your time to identify the risks and provide safety measures with regard to the use of harmful chemicals, biological materials, mechanical injuries and danger of electric shock.
- The validation protocol should include a strategy for managing possible ecotoxical effects and waste treatment methods.
- If the MSDS states an emergency telephone number of the manufacturer for use in the event of a spill, fire or hazardous exposure, it should be noted in the validation protocol.
- Only trained and experienced individuals should be involved in carrying out the validation. All participants must pass safety training before the initiation of the validation.
- The commencement of the validation process should be approved by a safety officer.
- Based on the results of the validation, the report should identify the factors and actions that require special attention in terms of safety and these should be reflected in the relevant sections of future work instructions and SOPs.
Example: Temporary electrical connections that do not meet safety requirements, commonly used in the preparation of the new equipment for validation.