Rules and Regulations Governing the Creation, Establishment, Operation and Maintenance of the Food and Drug Action Center (FDAC)

May 12, 2017

FDA ORDER NO. 010-17

I. BACKGROUND/RATIONALE

Rule VI Section 5 of Republic Act No. 9485 known as the "Anti-Red Tape Act of 2007" states in part that "Each office or agency shall establish a Public Assistance Complaints Desk in all their offices, where an officer or employee knowledgeable on frontline services shall at all times be available for consultation and advice. The desk shall be attended to even during break time." HTcADC

Furthermore, Rule VI Section 1 of the same Act on Accessing Frontline Services cites that "All offices and agencies are enjoined to undertake on continuing basic programs to promote customer satisfaction and improve service delivery and other similar activities for officers and employees in frontline services."

In keeping with the 3 marching orders of the Director General namely 1) 72-hour rule, 2) zero backlogs and 3) strengthened enforcement, the FDA made regulatory reform initiatives in streamlining and harmonizing its licensing and registration requirements.

It is in this light that FDA is committed and dedicated to level up not only its frontline services but all of its systems and processes to address the needs of our clients in the spirit of transparency, accountability and integrity guided by the principles and core values which FDA pledged to uphold.

II. OBJECTIVE

This Order aims to:

1. Establish, operate and maintain a customer service/call center in an effective and efficient manner.

2. Establish and implement a customer service program with standards of excellence for the delivery of quality customer service.

III. SCOPE OF APPLICATION

This Order covers/applies to all Centers/Offices/Units in the FDA Central, Regional and Satellite Offices. FDA regulated entities, private and other stakeholders.

IV. DEFINITION OF TERMS

1. Food and Drug Administration (FDA) — (formerly Bureau of Food and Drugs) was created under the Department of Health to license, monitor, and regulate the flow of food, drugs, cosmetics, medical devices, household urban hazardous substances, and other health products in the Philippines.

2. Food and Drug Action Center (FDAC) — stands for Food and Drug Action Center representing the Director General and the institution he/she represents. aScITE

3. High Priority — communications needing immediate attention of the Director General.

4. Head — the Director General of FDA.

5. Supervisor — the manager of FDAC designated by the Director General of FDA.

V. GENERAL GUIDELINES

A. The FDAC shall be directly under the Office of the Director General who will designate his/her duly authorized representative who will manage and supervise the FDAC facility. He/she will be assisted by the Director of the Administration and Finance Service.

B. The FDA Document Tracking Information System (DocTRAK) shall be used to register all incoming and outgoing communications for proper monitoring, transparency and accountability of the concerned FDA offices.

C. The FDAC shall serve as a referral center for all customer complaints whether verbal and/or written in nature.

D. It shall be used to receive all applications for registration, permits, certifications and other FDA authorizations.

E. It shall receive and encode written communications, request, follow-ups from walk-in clients as well as documents arriving via courier from all over the Philippines.

F. All high priority urgent communications shall be sorted out and routed to the Office of the Director General immediately.

G. The FDAC shall implement policies and guidelines for the delivery of prompt, responsive, effective and efficient support services of all Centers and Offices.

VI. SPECIFIC GUIDELINES

A. Personnel

1. The staff complement shall consist of at least the following:

a. Technical staff from each Center (Drug, Food, Cosmetics, Devices);

b. Administrative staff (Supervisor and Administrative Aide);

c. Data controller from Information, Communication Technology and Management Division (ICTMD);

d. Computer operator/technician;

e. Information Officers;

g. Cashier officer(s);

h. Records officer(s).

2. The Director of each Centre (Drug, Food, Cosmetics, Devices) is required to submit the names of the Officer of the Day to complement the staff at FDAC. HEITAD

3. All staff in frontline services at FDAC shall undergo trainings on customer satisfaction based on the training program and module developed by the FDA.

B. Equipment

 Appropriate equipment shall be provided with at least the following:

1. Internet Access

2. Telephones, headsets

3. Desktop computer terminals with the following software:

• FDA Document Tracking System

• FDA Inventory System (FIS)

• Internet Browser

• Microsoft Office (latest version)

• Adobe Acrobat Reader (latest version)

4. Printers

5. LAN (computers and printers)

6. Queuing System Device

C. FACILITIES AND ENVIRONMENT

1. The FDAC shall have an area of at least 250 square meters with provision for air-conditioning.

2. There shall be adequate lighting, ventilation and a comfortable environment.

3. The "No Smoking Policy" shall be strictly enforced.

D. Service Delivery

1. The operating hours shall be divided into two (2) shifts, from Monday to Friday except holidays. The first shift from 8 o'clock in the morning up to 5 o'clock in the afternoon, and the second shift from 9 o'clock to 6 o'clock.

2. The "No Noon Break Policy" shall be strictly observed. (Lunch break should be done on a rotation basis.)

3. The supervisor of the FDAC shall ensure the provision for uninterrupted logistical support from concerned officer, particularly the Administration and Finance Service (AFS), different Centers and Offices to effectively and efficiently deliver quality service.

4. There shall be a comprehensive plan of management of data and research for the improvement of the operating systems and procedures of the facility.

E. Submission of Reports

1. The preparation of accurate and timely submission of reports (as may be required by FDA) shall be strictly observed. ATICcS

2. The supervisor of the FDAC notifies the office and/or person concerned as deemed necessary on any decision, problems noted, action taken that would impact on customer care.

VII. QUALITY WORK PROCEDURES (QWP)

PROCEDURE	PERSON RESPONSIBLE
• Oversees the overall operations of FDAC during the entire working hours
• Reports in writing and/or verbally to the head of the FDAC on issues and concerns needing immediate decisions	Supervisor at FDAC
1. Incoming and outgoing records
• Receive and records incoming documents	• Staff from FDAC
• Sorts and forwards to the concerned office/supervisor	• Staff from FDAC
• Records and releases outgoing documents	• Staff from FDAC
2. Receiving of applications for FDA authorizations, complaints and other concerns:
• Receive applications for registration, permits, certifications and other FDA authorizations	• Technical staff from each Center Office
• Address complaints and other concerns of clients related to applications for FDA authorizations
3. Network Operations
• Ensures and maintains smooth IT operation and software troubleshooting as needed	• Designated staff from Information Communication Technology and Management Division (ICTMD)
• Submits reports to the system administrator any noted glitch on the system/program	• Staff from FDAC

VIII. REPEALING CLAUSE

Provisions from previous issuances that are inconsistent or contrary to the provisions of this Order shall be deemed impliedly or expressly amended or revoked.

IX. SEPARABILITY CLAUSE

In the event that any provision or part of this Order is declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected by such declaration shall remain valid and in force.

X. EFFECTIVITY

This Order shall take effect immediately.

(SGD.) NELA CHARADE G. PUNO, RPhDirector GeneralFood and Drug Administration