Quality Assurance (QA)
Divisi Quality Assurance memiliki peran dalam menjaga manajemen mutu produk Biofarma, melakukan audit manajemen lingkungan, audit sistem manajemen kesehatan dan keselamatan kerja (K3), audit praktik produksi yang baik (GMP), melakukan audit vendor serta mengaudit aduan pelanggan.
The duties of Head of Quality Assurance Division are performing following aspects :
1. Quality Management System
2. Environment Management
3. Health and Work Safety Management System
4. Good Management of Production (GMP)
6. Customers’ Complaints.
The authorities of Head of Quality Assurance (QA) Division
The Head of Quality Assurance and/ or Management Representative (MR) has the authority to approve the audit program and appoint the competent and independent audit team who shall perform the audit of every related Division/ Department and to request for unscheduled audits that have been determined with or without prior announcement to the auditee.
The responsibility of Head of Quality Assurance Division covers on the following points:
1. Integration Implementation of ISO 9001;
2. Integration Implementation of ISO 14001;
3. Integration Implementation of OHSAS 18001.
Head of the QA Service Department is responsible for preparing the schedules, audit programs, audit scope, and evaluation including the safekeeping of internal audit records and reporting of the audit implementation to the QA Division Head and/or MR. The internal audit schedule is prepared based on proper risk analysis.
The Position of Quality Assurance in Organizational Structure
According to the Directorial Decree No. 05586/DIR/VIII/2015 dated 21st August 2015 on the Organizational Structure of PT Bio Farma (Persero), the Quality Assurance (QA) Division is structurally under the purview of the President Director and headed by a Head of Division, who supervises QA System, QA Operation, and QA Service. The Organizational Structure of the QA Division of Bio Farma is as follows:
Corporate Secretary (Corsec)
The Corporate Secretary plays an important role in facilitating communication between the company and all stakeholders. the corporate secretary is also responsible for ensuring adherence to laws and regulations, as well as the disclosure of the company.
The Position of Corporate Secretary in Organizational Structure (Corsec)
The Corporate Secretary is a Board of Directors organ who plays a vital role to ensure the Company has complied with disclosures requirement aligned with GCG principles, to regularly and/ or at any time provide required information by Board of Directors and Board of Commissioners/ Supervisory Board to be a liaison officer, to arrange and to file the Company documents, Board of Directors, Board of Commissioners, and GSM minutes of meeting.
The Internal audit is an activity to provide assurance and independent and objective consultation to improve value and to fix Company’s operational by systematical approach by evaluating and improving the internal control system, risk management and good corporate governance.
Audit Internal Organizational Structure
Bio Farma established an Internal Audit led by the Head of the Internal Audit, appointed and dismissed by the President Director upon the approval of the Board of Commissioners. The IA is an objective and independent supervisory body established to provide added value in the Company’s performance by abiding to the principles of good corporate governance (GCG).
Compliance & Risk Management (CRM)
Corporate risk management is an effort to effectively identify, to analysis/ evaluate, to manage and to review the Company risks so the determined Company’s objective could be achieved with minimum risks. The Company’s obligation to implement Risk Management was referred to The SOE Ministerial Decree No: PER-01/MBU/2011 dated 1 August 2011 Concerning the Implementation of Good Corporate Governance in SOE and renewed with the SOE Minestrial Decree No: PER-09/MBU/2012 dated 6 July 2012. The Corporate Risk Management in Bio Farma was stated in Bio Farma Manual (MBF-01 and MBF-02.
Risk managing is a responsibility for everyone, therefore every employee should understand everyrisk related to their works and how to proactively manage them.Bio Farma is fully aware that the operational risks were integrated with various risks both controllable and uncontrolable.Therefore, suchs risks should not be ignored and should be integrally, optimally, continuously managed as an integral part of good corporate governance practices.
Since 2009, The Risk Management System implemented in Bio Farma is referred to COSO Enterprise Risk Management – Integrated Framework. In parallel with the design of Integrated Management System of Bio Farma, Bio Farma Risk Management System has been changed by bridging the COSO Enterprise Risk Management – Integrated Framework to ISO 31000 (2009).