Good engineering practice of updating standards

02-Feb-2020 21:19 by 2 Comments

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Thus, if employers have identified these standards or documents as RAGAGEP and are following the requirements laid out in these documents, then they likely will be in compliance with the standard’s requirements.OSHA also recognizes that non-consensus engineering documents or peer-reviewed technical articles addressing specific hazards may serve as RAGAGEP when published standards are not available or are not adequate to address specific hazards.

The PDA also desires this compatibility for the document "Guidance on Process Validation" (CPMP/QWP/848/96/draft) issued by the CPMP (Committee for Proprietary Medicinal Products), the medicinal products specialty committee of the European regulatory authority EMEA (European Medicinal Evaluation Agency).

The new guidance clarifies OSHA’s positions with respect to enforcing the PSM standards that reference or imply the use of RAGAGEP. § 1910.119 should carefully review their compliance with the following standards in light of this new guidance and OSHA’s renewed focus on the proper application of RAGAGEP to covered processes and equipment: Issuance of this memorandum signals that inspectors will be looking more closely at these requirements during PSM-related inspections and that they will specifically be looking for information on whether employers have identified and documented the appropriate RAGAGEP that applies to each piece of equipment and are following the inspection and testing requirements including frequency of those inspections and tests.

The memorandum provides the most detailed information on how OSHA will handle PSM inspections with respect to the RAGAGEP requirements and it includes 16 detailed enforcement considerations that inspectors will evaluate when reviewing an employer’s compliance. In this enforcement memorandum, OSHA recognizes that while the PSM standard does not define RAGAGEP and employers may select the RAGAGEP that will apply to their covered processes, there are several consensus standards that are widely adopted by federal, state and municipal jurisdictions and are generally accepted by OSHA as RAGAGEP.

If the adopted RAGAGEP provision applies to the covered process and the employer has adopted that approach, OSHA will presume that the employer’s compliance with the “should” language is appropriate.

However, if an employer chooses to use an alternate approach than the one provided under the “should” language, OSHA states that more investigation must be done to determine if it is appropriate.

In order for internally developed standards to serve as RAGAGEP, OSHA makes clear that the internally developed standards must either meet or exceed the protective requirements of the published RAGAGEP when it exists.

Employers who rely upon such documents to serve as RAGAGEP are encouraged to think strategically on how they can explain to OSHA why such documents should be considered to be RAGAGEP by the agency and provide for more stringent requirements than other documents.

OSHA makes clear that if the employer deviates from the “shall” and “shall not” requirements in the adopted RAGAGEP, it will presume that a violation occurred and a citation will be issued.

Moreover, OSHA asserts that “should” or similar language in the RAGAGEP reflects an acceptable and preferred approach.

If the employer finds that it has not implemented the “should” language, it needs to consider whether its approach is at least as protective and be prepared to explain how that approach protects employees to OSHA.

The memorandum provides a list of 16 enforcement considerations that will be considered by the inspector when evaluating whether an employer is meeting the RAGAGEP requirements under the PSM standard.

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