Objectives

The primary objective is to appoint a qualified training provider to deliver specialized Root Cause Analysis (RCA) training to fifty-five employees of Onderstepoort Biological Products Ltd. The initiative aims to strengthen internal quality assurance capabilities, improve incident resolution processes, and ensure consistent compliance with pharmaceutical manufacturing standards.

Scope

The supplier must conduct a three-day, face-to-face classroom training program focused on pharmaceutical manufacturing incidents and non-conformances. The curriculum must cover root cause identification, structured problem-solving steps, multiple RCA methodologies, preventive action planning, and root cause assessment. Deliverables include formal participant assessments, comprehensive study materials, digital copies of training presentations, and competency certificates upon successful completion. Instruction must incorporate practical, industry-specific case studies to ensure real-world applicability.

Technical Requirements

• The training provider must be officially registered and accredited by the Services Sector Education and Training Authority (SETA).
• Bidders must submit a fully completed and signed SBD4 declaration, certifying compliance with ethical procurement standards and disclosing any state employment ties or related business interests.
• All quotation submissions must be in PDF format; Word or Excel files will be automatically rejected.
• Evaluation utilizes an 80/20 weighted scoring model, allocating 80% to price competitiveness and 20% to preferential procurement goals per national legislation.
• Submission of all mandatory documentation is compulsory; failure to include required forms results in immediate disqualification.
• The awarded contract will be governed by the Government Procurement General Conditions of Contract (July 2010).

Skills Requirements

• The lead facilitator must demonstrate a proven professional background in pharmaceutical manufacturing operations.
• Mandatory experience working within environments compliant with ISO 9001:2015 (Quality Management Systems), ISO/IEC 17025 (Testing and Calibration Laboratories), and/or current Good Manufacturing Practices (cGMP).
• A detailed curriculum vitae highlighting relevant qualifications, sector experience, and previous training delivery must accompany the bid.

Key Terms & Definitions

Services SETA: A South African regulatory body responsible for accrediting training providers and ensuring educational programs align with industry workforce development standards.

SBD4: A standardized government bidding form requiring suppliers to declare independence from state influence, disclose related business interests, and certify adherence to anti-collusion and anti-corruption regulations.

cGMP: Current Good Manufacturing Practice, a regulatory framework ensuring pharmaceutical products are consistently produced and controlled according to stringent quality and safety standards.

ISO 9001:2015 & ISO 17025: Internationally recognized standards for quality management systems and laboratory competence, respectively, critical for maintaining operational excellence in regulated industries.

80/20 Preference System: A public procurement scoring model that prioritizes cost efficiency (80%) while reserving 20% for socio-economic advancement goals, including historically disadvantaged ownership, women-owned enterprises, and disability inclusion.