FICCI CE

Auditing of QMS

As per ISO 9000 : 2000

FICCI CE

Quality Policy

• Has the organization defined its mission?

• Have the factors critical to the accomplishment of mission been

analyzed to determine subjects to be controlled by the organization?

• How and by whom has the quality policy been formulated?

• Have the people responsible for implementation been involved in

development of the policy?

• How have regulatory requirements been considered in formulation of

the quality policy?

• How is the quality policy communicated throughout the organization?

FICCI CE

Quality Objectives

• Have quality objectives been defined in measurable terms?

• What is the basis for establishing quality objectives?

It could be: - customer expectations - past performance - standard of competitors

• Have the persons responsible for achieving objectives been involved in

the establishment of quality objectives, in order to secure their

commitment?

FICCI CE

Quality Objectives (contd….)

• How have the risks to achieving objectives been evaluated?

• Have appropriate objectives been established in different functional

areas which contribute to achieving overall objectives?

• How is the achievement of quality targets verified?

• What analysis is carried out in case of discrepancies between planned

and actual results?

FICCI CE

Organization

• Have you defined an organizational structure with clearly defined

responsibility and authority at all levels?

• What is the role of management representative and what is the

coordination process for ensuring that QMS is implemented and

maintained in all functional areas?

• Does the MR have appropriate status and authority to effectively

coordinate the activities of QMS throughout the organization?

• How does the MR promote awareness of customer requirements

throughout the organization?

• Does the MR have adequate secretariat support for the satisfactory

discharge of his duties?

FICCI CE

Human Resource Management

• How are the responsibilities within each role defined and assigned to

the various functionaries in the organizational structures?

• How do you determine the need of additional personnel and their

qualification and expertise.?

• How does the recruitment and selection process ensure that the defined

requirements of the staff are met?

• What is the process for identifying training needs and development for

all staff?

FICCI CE

Human Resource Management (contd….)

• What is the process for carrying out skills assessment, taking into

account current capabilities as well as needs based upon future

business objectives?

• What is the process for providing training and development?

• Is a training plan and record of training (both within the company and

outside) available?

• What improvements in HR have been planned?

• What improvement in results was obtained from the last review of the

human resource process?

FICCI CE

Physical Resource Management

Provision of Resources

• What is the process for provision of physical resources like buildings,

utilities, process equipment and supporting services?

• Have the responsibilities for planning and provision of different types

of physical resources been defined?

• Do the users of resources participate in the planning process?

• What is the basis for determining additional resources?

• Have you identified any specific work environment that affects

conformity to product requirement?

• What is the process to review whether adequate resources have been

provided?

FICCI CE

Maintenance of Physical Resources

• Have processes for maintenance of various types of resources such as

buildings and equipment been defined?

• Have the standards of various types of resources been established?

• How are maintenance processes controlled?

• How do you determine has any legal requirement impact on

maintenance?

• Have you out-sourced maintenance of buildings and any equipment? If

so, how are these services monitored and controlled?

• Have you established improvement objectives for maintenance? If so

to what extent have those objectives been achieved over a specified

period?

FICCI CE

Management of Services

• Have you determined what kind of services are required by the

organization? These services could be transportation, communication,

cleaning, security, etc.

• Have the processes for planning, procurement and control of these services

been defined and responsibilities allocated?

• Have the standards for these services been established?

• How is service performance assessed for conformity and improvement?

FICCI CE

Product Realization Processes

General questions

The following questions are applicable to all processes involved in

product realization:

• What is the purpose or output of the process?

• What are the pre-requisites for commencement of the process?

• What information and other resources are required for the process?

• What inputs are needed and where will they come from?

FICCI CE

General questions (contd….)

• What are the main stages of the process and how is interconnection

between stages managed?

• What controls are exercised for satisfactory operation of the processes?

• How are the results of the process measured?

• What action is taken when a desired output is not achieved?

These questions will oblige the process owner to examine all aspects of

any process. This will help bring clarity about the process and help in

effective management of processes.

FICCI CE

Marketing Processes

• What market research has been carried out to understand the sector in

which you operate?

• Have you identified factors necessary for your organization to succeed

in the market?

• How do you determine the current and future needs and expectations

of customers?

• How do you evolve the marketing strategy? Are other key functional

groups involved in this process?

• Once customer requirements are determined, how are these

communicated within the organization?

• How do you assess the effectiveness of marketing process?

FICCI CE

Sales Process

• Have you defined your sales strategy and established sales objectives?

• What are the key stages in the process to achieve sales objectives?

• How is information on the organization’s products and services

conveyed to potential customers and how is its integrity maintained?

• What are the principal activities of the process by which customer

inquiries are converted into orders?

FICCI CE

Sales Process (contd….)

• How do you determine whether the organization has the capability to

satisfy customer requirements before accepting orders?

• How are customer requirements of accepted orders conveyed to those

responsible for their implementation?

• How are changes in orders/contracts captured, accepted and conveyed

to those responsible for their implementation?

FICCI CE

Sales Process (contd….)

• What checks are carried out to verify that the customers receive the

products and services they have ordered?

• What analysis has been performed to determine the cause in the case of

differences between actual and planned results?

• What improvement in results was obtained from the last review of the

sales process?

FICCI CE

Design and Development Processes

• Do you have a system of preparing a design plan before starting any

design and development activity?

• Does the plan identify various design inputs and how these are to be

obtained?

• Have you defined various stages in the development processes

sequential and parallel work schedules and persons responsible for the

completion of design elements?

• Have you defined design and development output in verifiable terms?

FICCI CE

Design and Development Processes (contd….)

• Is systematic review of design and development carried out at suitable

stages? Is a checklist for such a review available?

• What is the process of design verification? Are the results of

verification recorded?

• Do you have a design and development validation process where you

have to demonstrate that the resulting product is capable of meeting the

requirements of the intended user?

• What is the process of making changes to the design?. Are these

changes verified and reviewed by authorized persons before

implementation?

FICCI CE

Purchase Processes

• Has the organization formulated a purchase policy and relevant

guidelines?

• How and by whom are the items to be purchased determined?

• Are specifications or detailed particulars of all items to be purchased

available?

• What is the process for determining quantities to be purchased?

• How do you determine the relevant legal requirements that impact the

purchase of these products?

FICCI CE

Purchase Processes (contd….)

• How are those who require any products involved in the purchase

process?

• How are suppliers assessed for their ability to supply conforming

product?

• Do you maintain an updated list of approved suppliers?

• How do you ensure that complete information about specification of

the products is provided to the suppliers?

• How do you ensure that any supplier is informed about the procedures

for approval of material and critical processes in cases where these are

applicable?

FICCI CE

Purchase Processes (contd….)

• What is the process for qualification of personnel when their skill is

critical for ensuring product quality?

• What is the verification process for critical materials or processes used

by any supplier (If required by purchase procedures)?

• What action is taken when there are minor deviations from the

specification which may not affect the serviceability of the product?

• What actions are taken when whole or part of a supplied product batch

is found to be non-conforming?

FICCI CE

Purchase Processes (contd….)

• What extra safeguards are adopted for verification when non

conforming product is submitted after rectification?

• How is the performance of suppliers evaluated? Are results of

evaluation shared with suppliers to enable them to improve?

• Are suppliers involved in quality improvement projects?

• What steps are taken to encourage long-term relationship with

suppliers?

FICCI CE

Production Planning

• What is your production policy to ensure that the right quantity of

products is produced at the right time to optimize utilization of

production resources?

• What are the inputs to production planning? These could be confirmed

orders, sales forecast and planned inventory levels.

• Have you carried out any process capability study of your equipment

to determine production capacity?

• What is the process of machine loading and work scheduling to ensure

smooth flow of production?

• How is production control exercised to ensure that planned production

is achieved?

• Are causes of production shortfall analyzed to improve the production

planning process and productivity?

FICCI CE

Process Planning for Product Realization

• Have you defined the sequence of operations or activities for each

product and the output required at each stage?

• Have you determined which process stages require written instructions

for proper compliance?

• Do your process plans specify parameters to be checked or measured

at different stages and how these measurements are to be carried out?

• Have you defined criteria for acceptance at each stage and actions to

be taken in case these criteria are not met?

FICCI CE

Process Planning for Product Realization (contd….)

• Does the process plan give details of tooling, software and measuring

devices to be used in the process?

• Where a customer-supplied product is to be integrated with the final

product, does the process plan provide specifications for such a

product and instructions for assessing conformity and related issues?

• Have you defined methods of identification and traceability where

these are applicable?

• Does the process plan contain instructions for preservation, packaging

and storage of the product where appropriate?

FICCI CE

Production Control

• How it is ensured that the concerned personnel fully understand

process plans and activities to be carried out by them?

• Where written instructions are required, have you ensured that these

are available at the workstations where they are applicable?

• What is the method of approval of any process before commencing

regular production?

• How do you ensure that specified process controls are being used and

are effective?

FICCI CE

Production Control (contd….)

• Do the operators know what corrective action is to be taken when a

process goes out of control or non conforming product is produced?

• How it is ensured that an out-of-control process is not operated until its

causes are determined and it is again brought under control?

• Have you defined action to be taken for dealing with non-conforming

product?

• What is the process for accepting product deviations that do not

significantly affect product serviceability?

FICCI CE

Control of Monitoring and Measuring Devices

• Are all monitoring and measuring devices uniquely identified?

• How it is determined that these devices meet the measurement

requirements of products and processes?

• Do you have calibration procedures and are records of calibration

maintained?

• Is calibration status clearly identifiable on the devices?

FICCI CE

Control of Monitoring and Measuring Devices (contd….)

• Are concerned personnel aware of proper handling, maintenance and

storage method to prevent damage/deterioration?

• Are suitable environmental conditions maintained for measurement

and calibration activities?

• What is the system of revalidation of previous measurements if the

measuring equipment is found to be out of calibration?

FICCI CE

Measurement, Monitoring and Process Improvement

• What are the methods for measuring and monitoring product-

realization processes?

• Are there records to show that the processes are being monitored and

necessary follow up action is taken to keep them under control?

• Is there a documented plan for inspection and testing of the product

(including acceptance criteria) before the release of any product?

FICCI CE

Measurement, Monitoring and Process Improvement (contd….)

• Is there a documented procedure for control of non-conforming

products?

• Have you defined what action is to be taken if defects are found after

delivery and is there an adequate product recall procedure?

• Is there a procedure for corrective and preventive action to prevent

occurrence of defects?. Does it address the root causes on the basis of

investigation and analysis of non-conformities?

FICCI CE

Measurement, Monitoring and Process Improvement (contd….)

• Is there a documented procedure for measuring customer satisfaction

and handling of customer complaints?

• Are internal audits carried out according to a plan, and the necessary

follow up action taken?

• Are there documented audit procedures along with a check list?

• Is there a formal system for analysis of data for continuous

improvement of processes and the quality management system?