Quality Managament

1. Apa Itu Mutu? / What is Quality?

- Mutu adalah kemampuan sesuatu untuk memenuhi keinginan.

- Degree to which a set of inherent characteristics fulfills requirements* (ISO 9000:2005)

*Requirement: Need or expectation that is stated, generally implied or obligatory

2. Apa Itu Manajemen / What is Management?

- Manajemen adalah bagaimana cara kita mengerjakan sesuatu bersama-sama dengan

orang lain.

- Coordinated activities to direct and control an organization. ((ISO 9000:2005)

3. Apa Itu Manajemen Mutu / What is Quality Management?

- Kegiatan terkoordinasi untuk mengarahkan dan mengendalikan organisasi dalam hal

mutu

- Management with regard to quality.

Coverage

- Quality Management System

- Quality Assurance

- Coordinated activities, to direct and control an organization with regard to the degree
of inherent characteristics fulfill the requirements.

4. Apa Itu Sistem/ What is System?

- Satu kesatuan yang terdiri dari bagian-bagian yang saling terikat dan berinteraksi

- Set of interrelated and interacting elements (ISO 9000:2005)

- Set of interrelated and interacting elements of coordinated activities, to direct and control an
organization with regard to the degree of inherent characteristics fulfill the requirements.

5. Apa Itu Quality Management System/ What is Quality Management System?

- prosedur dan standar praktis yang terdokumentasi dan tertulis untuk memenuhi
keinginan.

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 - System with regard to Quality Management System (QMS)

Coverage of QMS:

- Organization Structure, Procedures,

- Processes and Resources.

6. Bagaimana proses dasar QMS/ QUALITY MANAGEMENT SYSTEM ISO 9000

The Process Based QMS?

7. What is Quality Assuranse?

The totality of systematic actions necessary to ensure adequate confidence that a

product (or service) will satisfy given requirement s for quality. Basic Principle: “Do it
right from the first time ,and every time.”

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8. what is Principles of Quality Assuranse?

• Make quality people before making quality product.

• Build quality into the product.

• Do it right from the first time.

• Do what was written and write what is done.

• The 5 NOs : Don’t make, deliver , accept, keep and use defect product.

• The next process is our customer

9. How to Apply Quality Management?

 Practice The 8th Principles of Quality Management

 Practice Management Principles (POAC or PDCA)

Management Level (POAC)

Plan: Plan The System (QMS)

Organizing : Organize the activities (QA)

Actuating : Actuate the Activities (QA)

Controling : Control the results and plan preventive and correction action (CAPA)

Operator Level (PDCA)

Plan: Plan the job and resources (5M)

Do: Do the Plan

Check: Check the resources, processs, and results

Act: solve the problem, propose preventive and/or corrective actions

 Practice Management Review : - CAPA

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 10. What is the Process?

Process is the activity to transform input into output using resources

Efficient Management
Input OUTPUT (Effective)
5M > PROCESS
Product

Customer Requirements Customer Satifaction

Feed back

: Value added flow

: Information flow

Effective: Achievement the goal

Efficient : Using a minimum resources and time

Productivity: Effectiveness/ efficiency

11. What is the Purpose of Quality Management ?

 To fulfill customer requirements

 To assure effectiveness and efficiency
 To assure quality
 To eliminate reprocesses
 To satisfy customer and other stake-holders
 To be able to compete
 To maintain sustainability

12. What is The 8th Principles of QMS ISO 9000?

• Customer focus

• Leadership

• Involvement of people

• Process approach

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 • System approach to management

• Factual approach to decision making

• Mutually beneficial supplier relationships

• Continual improvement

13. How to Product realization in GMP of Pharmaceutical Product?

14. Apa Itu CPOB?

CPOB: peraturan dari BPOM mengenai cara atau pedoman pembuatan obat yang baik
untuk menjamin atau memastikan mutu obat diproduksi dan diawasi mutunya secara
konsisten agar obat yang dibuat memenuhi spesifikasi atau persyaratan mutu sesuai
dengan tujuan penggunaan obat dan memenuhi persyaratan izin edar.

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15. What is GMP Resourses ?
 Personnel
 Premises
 Equipment
 Material
 Documentation

16. What is GMP PROCESSES?

 Qualification and Validation
 Sanitation and Hygiene
 Good Practices in Production
 Good Practices in Quality Control
 Contract Manufacture and Analysis
 Self-Inspection and Quality Audit
 Complaints
 Product Recall

17. ICH Q10 PQS

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