1.What is SAP QM ?
QM = Quality Management
SAP Quality Management (QM) assures that products meet stringent regulatory standards, are safe and uniform, and meet company product specifications. SAP QM processes are thoroughly integrated into the manufacturing process.
2.How to Prepare the Functional Requirements Specifications (FRS) ?
IBM itself is having separate division (Life Science) to perform the CSV. Refer to them / contact them to get the FRS.
3.How to get inspection lot certificate ?
use QC21 – Quality Certificate
4.How many partner functions are there in SAP ?
Three Partner Functions in MM Module.
5.What is the differences between I.S.O and C.M.M levels ?
The CMM is a way to communicate capabilities.The ISO is a way to communicate the process.
CMM is a very specific way of classifying an organization’s software development methods. BUTISO-procedures describe a (possibly) definite development and process but gives no indication of the likely quality of the designs or whether multiple software efforts are likely to produce software of similar quality.
ISO is international organization for standardization located in Geneva-Switzerland, which publish standards in coordination with all countries (national standard institutes), but CMM is company maturity model used by the organization to demonstrate their capability performance and subsequently improve level by level.
6.What is a Quality Management Plan (QMP) ?
A QMP is a formal plan that documents an entity’s management system for the environmental work to be performed. The QMP is an “umbrella” document which describes the organization’s quality system in terms of the organizational structure, functional responsibilities of management and staff, lines of authority, and required interfaces with those planning, implementing, and assessing all environmentally related activities conducted.
7.What are the benefits of Quality Management System ?
QMS means to establish the process and procedures to follow while obtaining the company quality objective.and to ensure that the organization is foloowing them to satisfy the customers.
In the region, where there is no quality management, what would you do to introduce the concept of TQM ?
Where Quality processes are not avaialble, I would encourage them to identify and document their each and every task for each process.
Then, I would encourage them to define and document what they can do for minimizing human or machine errors.
I would encourage them to identify wastages like material or time wasters and define process to minimize these wastages. I would ask them to record and document each finding and strive to improve each process.
8.What is the difference between quality assurance and quality control ?
Quality Assurance is the part of quality management focused on providing confidence that quality requierements will be fulfilled while Quality control is focused on fulfilling quality requirement.
9.What are the quality principles ?
There are 8 quality principles such as 1) Customer focus 2)Leadership, 3) Involvement of people, 4) process approach, 5) System approach to management 6) Continual improvement 7) Factual approach to decision making, 8) Mutually benificaial supplier relationship
10.What are Six mandatory Quality procedures ?
1. Control of documents
2. Control of records
3. Control of Production Equipment, tools and CNC programs
4. Control of Non conforming products
5. Preventive Action
6. Corrective Action