PROSEDUR VS PROSES

Dalam ISO 9001:2008 ditegaskan di sana bahwa pendekatan yang digunakan adalah pendekatan proses (process approach) yang juga merupakan salah satu dari Prinsip Manajemen Mutu.

Ini merupakan sesuatu yang positif di mana dalam pendekatan ini "kerja nyata" (pinjam istilahnya Hatta Rajasa) sangat ditekankan daripada uprek dengan dokumentasi. Artinya, orang yang "gedebak-gedebug" bekerja, sepanjang outputnya adalah nyata/terukur sesuai objective, maka dia telah melakukan sesuatu yang "benar" meskipun barangkali dia "menyalahi" prosedur. Tinggal diakurkan saja mana yang sebaiknya, apakah prosedurnya yang direvisi mengikuti "praktek" gedebak-gedebug tadi, ataukah aktivitasnya yang diluruskan agar efektif (atau malah efisien).

Kita selama ini dirancukan dengan istilah "prosedur" dan "proses", bagaimana sebenarnya kejelasannya. PAS 99:2012 pada klausul A.2 menegaskan :

"Oftern the word "procedure" is used in MSS and there can be confusion as to what a procedure is and how it relates to a process. In simple terms :

* a process is an activity;

* a procedure is the formalization of the process (i.e. stating how the process should be performed, which may be documented)."

Terjemahan untuk yang diberi pointer kira-kira :

* proses adalah suatu aktivitas;

* prosedur adalah formalisasi dari proses-proses (misalnya ketentuan bagaimana suatu proses harus dilaksanakan, yang di antaranya mungkin wajib didokumentasikan).

Ini penting khususnya bagi Tim Audit Internal agar dalam proses auditnya beranjak dari tadinya "document-minded" menuju ke "result minded".

Salam Quality (JS)

ISO 9001:2008 SIMPLIFIED

Part 1: Scope, Part 2: References, Part 3: Terms and definitions

Part 4: Quality management system
General concept is to:
- Say what you do and do what you say (PDCA)
Documentation requirements
- Write down the important things
- Get organized to achieve quality
- Make directions available to users
- Keep directions up-to-date (as long as needed)
- Identify needed records and maintain them

Part 5: Management responsibility
Provide vision and commitment to quality
Plan to achieve quality
- Establish quality objectives
- Keep the quality management system current
Define duties and responsibilities
- Define and communicate responsibilities and authorities
- Put someone in charge of the quality program
- Communicate within the organization
Monitor the operations
- Periodically, to ensure suitability, adequacy and effectiveness of quality management system
- Inputs from both internal and external sources
- Outputs to cover QMS, product, and resources
- Keep records

Part 6: Resource management
Determine and provide resources for:
- Implementing and maintaining the QMS (including improving effectiveness)
- Enhancing customer satisfaction
Allow people to excel in their work
- Determine competencies and provide training
- Give them the tools and equipment to do the job
- Determine and manage the work environment

Part 7: Product realization
Define the process steps before doing it
- Product specifications
- Processes, instructions, and resources to make it
- Quality control (test and inspection) needed
- Records to prove it to outsiders
- Called "quality, production, or run plans"
Know what the customer wants
- Determine all the requirements
- Make sure you can do it (contract review)
- Keep the customer in the loop
Design for quality
- Create a design plan
- Define the design input (requirements)
- Capture the design in useful documents
- Periodically review the design process
- Verify that you did what you promised
- Validate the design to see if it really works
- Control changes to the design
Use good stuff from your suppliers
- Know what you want
- Check out your suppliers and monitor them
- Verify you received what you ordered
Control your production and service
- Make it under controlled conditions
- Validate processes that can’t be measured
- Match the job to the specs and show the status
- Keep track of what you make (if required)
- Don’t break your customer’s stuff
- Keep it good as it proceeds through production and delivery
Check the work with good equipment
- Identify information needed for monitoring (process) and measuring (conformity)
- Identify the devices needed for both
- Control monitoring and measuring processes
- Make sure measuring equipment is good

Part 8: Measurement, analysis and improvement
Develop ways to measure QC, QA, QM
Monitor your customer’s perception of your quality
Audit your quality management system
Monitor your internal processes
Measure the product characteristics
Don’t accidentally ship or use bad stuff
Properly dispose of bad stuff
Collect information and analyze it
Continually improve the QMS effectiveness

That's it!
Labels: quality


Source: http://auditguy.blogspot.com/2011/06/iso-90012008-simplified.html