Which statement about hazard analysis documentation is accurate?

Which statement about hazard analysis documentation is accurate?

• A. A written hazard analysis is required for all products
• B. Digital hazard analyses are prohibited
• C. Documentation is optional
• D. A digital or written hazard analysis is required

Answer: (D)

Hazard analysis documentation must exist in some recorded form. The rule allows either a digital or a written format, as long as the analysis is documented, current, and maintained as part of the preventive controls plan. This flexibility helps different facilities capture the hazards, justify the chosen preventive controls, and show evidence during audits. Therefore, stating that a digital or written hazard analysis is required is accurate. The other statements are not correct because they imply only a written format, prohibition of digital, or that documentation is optional, which the rule does not permit.

Hazard analysis documentation must exist in some recorded form. The rule allows either a digital or a written format, as long as the analysis is documented, current, and maintained as part of the preventive controls plan. This flexibility helps different facilities capture the hazards, justify the chosen preventive controls, and show evidence during audits. Therefore, stating that a digital or written hazard analysis is required is accurate. The other statements are not correct because they imply only a written format, prohibition of digital, or that documentation is optional, which the rule does not permit.