January 25, 2009

Major Non-Conformance Vs Minor Non-Conformance

Major Non-Conformance

Minor Non-Conformance

Total breakdown of system, control, or procedure.
Absence of an ISO 9001 requirement

Failure to conform to a requirement which (based on judgment and experience) is not likely to result in QMS failure

A number of minors related to the same clause

A single observed lapse or isolated incident

An nonconformity that would result in probable shipment of nonconformity or un-inspected product
A condition that may result in the failure or materially reduce the usability of product for intended purpose;
A nonconformity that experience and judgment indicate will likely result in QMS failure or materially reduce its ability to assure controlled processes and products

Minimal risk of nonconforming product or service

Majors represent serious problems in the system that must be addressed with attention and resources on a priority basis. It puts the business at risk with customers and the Registrar.

Minor nonconformities have little likelihood of allowing nonconforming product or service to be delivered or causing a breakdown of system control. It does indicate that there are occasional lapses that must be formally addressed through corrective action.

Examples:

 

No documented procedure for any required element of the standard

Document changes routinely carried out in an unauthorized manner
Critical purchases made from unevaluated suppliers

Product shipped without required inspection and tests

Examples:


A drawing marked up with unauthorized changes
A purchase order released without review and approval
An inspection instrument past its calibration date
A training record not available

January 4, 2009

Mission Statement Vs Vision statement

Mission Statement

Vision Statement

States the fundamental purpose of the organization.

Outlines what the organization wants to be.

Concentrates on the present

 Concentrates on the future

It defines the customer and the critical processes. It informs you of the desired level of performance

It is a source of inspiration. It provides clear decision-making criteria.

A Mission statement defines the purpose or broader goal for being in existence or in the business and can remain the same for decades if crafted well.

A Vision statement is more specific in terms of both the future state and the time frame. Vision describes what will be achieved if the organization is successful

December 16, 2008

Functional Audit vs Physical Audit

 

Functional Audit

Physical Audit

 

Objective: To provide an independent evaluation of software products, verifying that its configuration items’ actual functionality and performance is consistent with the requirement specifications.

 

 

Objective: To provide an independent evaluation of a software product configuration item to confirm that components in the built version map to their specifications.

 

Audit Requirements:

 

1. Software Requirements Specification (SRS), System Specification (SS)

2.  Waiver or Deviation List Prepared

3.  Verification Test Procedures Prepared.

4.  Verification Test Procedures Reviewed and Approved.

5.  Verification Test Data and Results Reviewed and Approved

6.  Test Results submitted.

7.  Test Readiness Review completed

8.  Test Readiness Review minutes and open action items from past reviews available

9.  Copy of baseline and database change requests with their associated status accounting records along with all design provided

Audit Requirements:

 

1.  Approved final draft of the configuration item (CI) product specification.

2.  A list delineating both approved and outstanding changes against the configuration item.

3.  Acceptance test procedures and associated test data.

4.  Findings / Status of quality assurance programs.

5.  Manuscript copy of all software CI manuals.

6.  Computer Software Version Description Document.

7.  Current set of listings and updated design descriptions or other means of design portrayal for each software CI.

8.  FCA (Functional Configuration Audit) minutes for each configuration item.

December 13, 2008

Policy Vs procedures

Policy

Procedures

Policy provides the operational framework within which the institution functions.

If policy is “what” the institution does operationally, then its procedures are “how” it intends to carry out those operating policy expressions.

In other words “a set of principles that are used as a guide for action, esp. in a government or business”.

In other words “a series of actions necessary for accomplishing a particular goal; course of action”

Widespread application

Narrow application

Changes less frequently

Prone to change

Usually expressed in broad terms

Often stated in detail

Statements of “what” and/or “why”

Statements of “how,” “when” and/or and sometimes “who” sometimes “who”

Answers major operational issue(s)

Describes process

June 17, 2008

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