Quality Organization

Pharmacist Profession ProgramFaculty of Pharmacy-Pancasila University

2016

ISO 9001:2015

Personnel

The establishment and maintenance of a satisfactory system of quality assurance and medicinal products relies upon people. For the reason there must be sufficient qualified personnel to carry out all task which are the responsibility of the manufacturer.

(Chapter 2-CPOB, 2012)

Quality Organization

The conditions that underlie the achievement of

high performance within quality organizations are:

1. Creating recognition,

2. Generating confidence,

3. Developing fit,

4. Providing direction,

5. Building commitment.James A. Belohlav, DePaul University

Quality Organization

Creating Recognition• For any organization to exist, there must be people who are

willing to perform activities for that organization-in other words, there must be employees.

• For a company to achieve high levels of performance, the employees must not only become a part of but also believe that they belong to the organization.

• A quality organization differs from most other organizations because one of its primary activities involves instilling a sense of belonging in all employees.

Generating Confidence• The magnitude of confidence prevailing within any

organization is directly proportionate to the amount of credibility and integrity that is present in employees' actions.

• Implementing an atmosphere of confidence requires that support and feedback be present in daily activities.

• Within quality organizations, support means helping employees produce a better product or service for the customer and removing obstacles that can interfere with getting work done effectively.

• Support and feedback create openness in the organization. Openness enables employees to understand how each other's activities fit into the big picture, take action when things are unclear, recognize opportunities for improvement, and be receptive to change.

Developing Fit

• Productivity can only be increased when the employees and the organization fit together.

• To make a person fit, he or she must understand what the organization is about, how it operates, and what is important to its success.

• Until the company can visualize what it wants to achieve, every action has the same meaning. Employees assume their roles as actors and actresses in the corporate play to get their paychecks so that they can do what they really want to do.

Providing Directions

• A company needs to send its charged-up people in the right direction.

• Setting people in the right direction is accomplished through organizational focus.

• Setting people in the right direction is usually an easy endeavor since there is already a point of reference from which to start.

• Only employees who' are developed to their full potential can see change as an opportunity and take advantage of it.

Building Commitment

The final activity is, developing commitment in the company.

An important distinction must be made about this stage:

Commitment and loyalty are related but not synonymous. Loyalty is

almost always present when there is commitment, but the converse

is not necessarily true. With loyalty, a company does not necessarily

get high performance. Only when there is commitment can the

highest levels of quality, productivity, and innovation be achieved.

Building Commitment

A high level of commitment is evident in three ways:

1. Typical organizational problems, such as employee discipline or absenteeism, no longer require major time and effort to resolve.

2. The organization is more creative. With commitment, individual ownership is generated.

Building Commitment

3. Employees use their discretionary time-time that they could be

spending on other activities-working for the organization because

they are motivated to do so and because they receive satisfaction

from doing their jobs and from being associated with the

organization itself.

4. The secret of the quality organization is that it creates not only

high-performance processes or systems but also values that

underlie those processes and systems.

Sumber : Priyambodo, 2007

Pendahuluan

a) Organisasi mutu melekat pada struktur organisasi perusahaan.

b) Fungsi manajemen mutu, penekanan kepada level Top

Management. Terutama berkaitan dengan Kebijakan Mutu.

c) Fungsi jaminan mutu, penekanan kepada bagian Quality Assurance / Penjaminan Mutu (QA).

d) Fungsi pengawasan mutu, penekanan kepada bagian Quality Control / Pengawasan Mutu (QC).

Top Management

₪ Pengambilan kebijakan strategis dalam perusahaan.

₪ Fungsi perencanaan secara luas₪ Mengelola seluruh sumber daya₪ Presdir (CEO) dan Plant Mgr

Sumber : Priyambodo, 2007

Penjaminan Mutu (QA) Semua aspek yang secara kolektif maupun

individual mempengaruhi mutu produk, dari konsep desain hingga produk itu ditangan konsumen (WHO, 2004).

Tujuan : o Produk memenuhi persyaratan mutu.o Fokus kepada konsumen

Tugas Penjaminan Mutu

Compliance

• Inspeksi Diri, Audit Mutu dan Audit Pemasok• Sistem Dokumentasi• Pelatihan• Pengelolan Pengolahan Ulang

PPQM

• Pelulusan Produk Jadi• Keluhan, Penarikan Produk dan Produk

kembalian• Pengelolaan Penyimpangan dan Perubahan

Validation

• Validasi• Kualifikasi & Kalibrasi• Studi Stabilitas

Pengawasan Mutu (QC)Quality control is the part of GMP concerned with :a) Samplingb) Specifications & testingc) Documentationd) Release ProcedureQuality control is not confined to laboratory operations, but must be involved in all decisions concerning the quality of the product.The independence of quality from production is considered fundamental.

Pengawasan Mutu

• Pengawasan selama proses produksi

In Process Control (IPC)

• Pelulusan Bahan Baku• Pelulusan Produk• Monitoring Lingkungan

Microbiology

• Pemeriksaan Bahan Baku dan Bahan Kemas• Pemeriksaan Produk Jadi• Pengelolaan Sampel Terpisah

Chemical Laboratory