Quality Audits

Introduction:

Methods used by Organizations to Provide Quality

Assurance
1. Quality Audits
2. Quality Surveys
3. Product Audit
 Introduction:

Quality audit is an independent review carried out to

compare the aspects of quality performance of the
product with the standard performance….unbiased
picture…cross-check and conformance of
producers’ promise
 Introduction:

The usual purpose of quality audits is to assure that:

 Data provided is accurate and adequate information
on quality is provided to all concerned
 Plans for attaining quality are such that intended
quality can be actually attained.
 Conformance to specifications
 Products are fit and safe for use
 Laws and regulations are being followed
 Introduction:

Covers various aspects viz.

1. Policies and procedures regarding
(a) Operation
(b) Quality Control
(c) Records, interpretations, corrective action
(d) Administration
 Introduction:

2. Operating Effectiveness involving

(a) Cost Control
(b) Equipment Control
(c) Inter-departmental coordination
(d) Assessment of product quality
 Introduction:

3. System effectiveness covering

(a) Storage and handling practices
(b) Field complains and corrective action
(c) Tool and gauge control
(d) Product design changes
Mode of conduct could be an unannounced visit, or
planned with mutual consultation
 Types of Audit:

1. External Audit
(a) Adequacy Audit
(b) Compliance Audit
(c) Extrinsic Audit
 Types of Audit:

2. Internal Audit – Purpose is to ensure the following:

 SOPs are used by all
 Deficiency in preparation and improvement in SOPs
 Any misunderstanding by field personal regarding expectations of
SOPs
 To validate or dispute external audit results
 To help in development of new SOPS
 To conduct annual Quality Control Checks
 Audit Procedure:

Step 1: Audit Initiation

Step 2: Audit Planning
Step 3: Audit Implementation
Step 4: Audit Reporting
 Deficiencies of Quality Audits:

Do not address the following points:

1. Relative standing of the product in marketplace
with respect to Quality
2. Feedback of user
3. Opportunities for reducing costs of poor quality
 For effective Quality Audits:

Take care of following points:

1. Prioritize Quality-related Activities
2. Define clearly the subject matter of audits
3. Switch Resources
4. Reference Standards (Reference IS, 10201-1988)
Comments/ Issues: