- Cost of non-quality biaya rapat, investigasi, biaya complain konsumen - (HYSTORY) Key element: 1. Numerous system 2. company Principle & knowledge memiliki pengetahuan yang dalam&luas 3. GMP, Regulation & Requipments 4. cross category - (USE) 1. Manageable section of GMP 2. Defined standards 3. Category specific level & document 4. Focus improvement - (SCORING) 1. 0-10 rating scale perlu adanya scor untuk penilaian 2. No average tiak bisa dirata-ratakan dengan hasil yang lain. 3. Implementation & Evectiviness selama 3 bulan melakukan pekerjaan sesuai SOP atau tidak, dilihat dan dibandingkan dengn SOP yang ada dan dibandingkan dengan yang sebelumnya. 4. Easy Comparation - LEADERSHIP 1. Personal Leadership memiliki sifat pemimpin, bukan bos. 2. Define Requirements & Targets memiliki target disetiap pekerjaan 3. Standar setting memiliki standar sebagai pembanding hasil yang diperoleh sudah sesuai atau belum 4. Understanding of Quality Principles 5. Development of a Quality Culture ada standar IPC orang produksi 6. “Right first Time” operations mengambil kesempatan yang ada 7. Elimination of Rework & Scrap 8. Quality cannot be tested in - ROLES & RESPONSIBILYTIES OF LEADERSHIP Mission statement/Quality Policy Define concept of Qulity memiliki standar kualitas Establish Commitment to Quality memegang komitmen standar Empower all - GOAL STATEMENT 1. Definition of state goals 2. Describe quality performance dilihat misalnya dala satu bulan mendapat hasil berapa, bagaimana, sesuai standar atau tidak 3. Consistent with company quality goals - QUALITY POLICY COMMUNICATED & IN PLACE 1. Communication process berkomunikasi dengan baik 2. Performance & Behavior 3. Introducition Training Program memberikan simulasi kepada tenaga kerja baru - LEADERSHIP BEHAVIOR 1. Principles in mission statement 2. Set the example & standars (menjadi contoh para pegawai) 3. Leaders & coaches, not bosses (sikap yang kekeluargaan, tidak menjadi bos yang semena-mena) 4. Personality involved in quality 5. Active involvement in quality 6. Review of QI’s, defects, and QAC (QACapability) 7. Visible participation memberikan apresiasi - DESIGN STANDARS IN PLACE 1. Re-application of Benchmark system 2. Consistent quality standards 3. Standardiazion & simplification - ORGANIZING FOR QUALITY Product Development Role and Responsibilities Formula Cords & specification Production Roles & Responsibilities: Manufacture to Standards & Spec QA Roles & Responsibilities: Authority & Reporting Relationship - ORGANIZING FOR QUALITY Board Participant 1. Objective cool system and daily management system measure published 2. Personel clearly understand their role 3. Individuals empowered to improve quality 4. Regular review conducted 5. Recognition of employee participation 6. Performance review connection - ORGANIZING FOR QUALITY Design standars in place 1. Everyone’s respomsibility 2. Quality cannot be tested in 3. Roles & respomsibilities