Qastation

Implementation of QMS (Part4)

qastation — Sat, 03 Oct 2009 07:08:17 +0000

Learn From Others & Share Your Experiences

As it was trail or test ride, implement the same across the organization at full fledge, since the procedures / process is matured one now. For implementation of the procedures / process to the full fledge the existing team which is already had used, need to spend time to share their experience with others and help them to get learned.

Quality is a team work rather than individual one.

Implementation of QMS (Part3)

qastation — Sat, 03 Oct 2009 06:38:04 +0000

Have periodic reviews and Audit Trails

Before go for the audit, let have some pre-audits in terms of SQA reviews. Identify couple of resources of different teams to take up audit. Train them to the level of internal auditor and prepare a checklist for the reviews. This may help the organization to know the performance of the QMS as well the gaps in the QMS. Consolidate the SQA review report and send for analysis to the subject expert. If the identified gaps are addressed as risk in the procedures then rise PCR (Process Change Request) and make changes according as the direction of CCB ( Change Control Board). By this way the established procedures get maturity.

On maturity of the procedures, plan for audit. Have a deep discussion and identify the gaps in the practice (ground) and procedure (theory). Again consolidated it and review the same. If the identified gaps are risk then address them at high priority. Since it’s a continual process improvement, address the same with enthusiasm rather frustration.

Implementation of QMS (Part2)

qastation — Sat, 03 Oct 2009 06:16:37 +0000

Define, establish and implement procedures

On avail of policy and objectives, define procedures across the organization. Procedures are nothing but the systematic way of doing something. As said it’s systematic, so rather you define the procedures / process allow the team who is going to work on to define. On definition of the process / procedures by the team, identify the gaps and analysis the same with the quality standards or models (ISO, CMMI & etc). Prepare review comments and go for discussion, so that procedures / Process get tuned. Once it’s been accepted on either side (You & team), incorporated the review comments with the existing procedures.

On establishment of procedures we need to implement the same across the organization on different projects. For implementation, select one or more projects for the test ride. Once the projects are been selected, prepare a plan for the training to the required resources, so that they may effectively use the QMS. Allow the team to use the QMS for while with the plan stating that met up somewhere after three or fours months later for audit trail.

Implementation of QMS (Part 1)

qastation — Fri, 02 Oct 2009 07:29:11 +0000

Define Quality Policy and Quality Objectives

Based upon the vision and mission statement of the organization, the top management will freeze the policy and objectives that need to be managed or maintain to meet its business goal. To be honest if prepared this with value, can measure the performance of the quality management system to great extent, but mostly in order to meet the requirements of the ISO 9001:2008, organizations establish this as a part, without any value or meaning. However it’s depends upon the individual or the organization who defines the same, since ISO 9001:2008 is the generic management system rather specific.

Constraints need to be considered while on working with policy and objective is what need to be done or what need to be managed to meet the business goals. For an example if we are going to define the policy for a startup company (of embedded systems of any particular products). Let us consider its vision statement is “Be leader in the network and embedded arena” and the mission statement will be “Deliver products on time with high quality”.

By combining both the vision and mission statement, came to the conclusion that the company want to maintain it’s delivery with high quality and on time for long run. So putting up this all in a line can say its policy as “Provide solutions & services or Products and services (supplier) that met the expectations of the customer (customer) in terms of Cost, Time and Quality”.

As defined the policy above, need to look into objectives to carry forward this policy. Quality Objectives is the measurable items at the end of the day to know where we are. From the above statement (policy), it’s clear that the measurable objects or items will be schedule, effort and quality (quality may be in terms of Defect Removal Efficiency, Customer satisfaction feedback & on time delivery).

Major Non-Conformance Vs Minor Non-Conformance

qastation — Sun, 25 Jan 2009 13:14:43 +0000

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

Mission Statement Vs Vision statement

qastation — Sun, 04 Jan 2009 06:40:46 +0000

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

Functional Audit vs Physical Audit

qastation — Tue, 16 Dec 2008 15:48:57 +0000

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.

Policy Vs procedures

qastation — Sat, 13 Dec 2008 05:37:42 +0000

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

Please do give your valuable feedback regards qastation posts

qastation — Tue, 17 Jun 2008 06:18:27 +0000

Dear Visitors

Do give your comments / suggesttion at the comment section of each post which will help us to improvise ourself to post more topics in the future.

Types, Objectives & Techniques of Review

qastation — Sun, 15 Jun 2008 10:17:23 +0000