Professional Documents
Culture Documents
QMS Q&a
QMS Q&a
QMS Q&a
5. What is QA?
• Planned and systematic actions established to ensure that process performed,
data are generated, documented, activities implemented within QMS and
demonstrated as needed, to provide adequate confidence that entity
(services, product, process activity, or organization) will fulfill quality
requirements.
• Process of monitoring specific results to determine if they comply with
relevant quality standards, and identifying ways to eliminate causes of
unsatisfactory performances.
• System of procedures, checks, audits & corrective actions to ensure that
quality requirements are fulfilled / exceeded.
12. What's the difference between design verification & design validation?
• Design verification is a process whose purpose is to examine design
outputs and to use objective evidence to confirm that outputs meet design
input requirements. Your purpose here is to see whether your design outputs
meet your organization's design goals. Design validation is a process whose
purpose is to examine products and to use objective evidence to confirm that
these products meet customer needs and expectations. Your purpose here is
to see whether your product does what your customer or user wants it to do
under real-world conditions.
31. Why & what is important of submitting monthly quality management report?
• It’s a record showing project progress of quality function and activities at
stages of procurement & construction to ensure that objectives are met as per
schedule-Q & project quality plan requirements.
Quality Plan: Document specifying which procedures and associated resources shall be
applied by whom and when to a specific project, product, process or contract. [ISO 9000]
Type Test: Test or series of tests directed towards approval of a design conducted to
determine that is capable of meeting the requirements of the product specifications.
Hold Point: Inspection or Test may not proceed without the QA/QC organization
representative in attendance.
Witness Point: It defines a point that provides QA/QC organization with the opportunity to
attend the Inspection or Test, at their option.
Shall: "Shall" expresses a provision that is binding between two or more parties.
Capability: Ability of an organization, system or process to realize a product that will fulfill
the requirements (3.1 .2) for that product
Management System: System to establish policy and objectives and to achieve those
objectives.
Quality Planning: Part of quality management focused on setting quality objectives and
specifying necessary operational processes and related resources to fulfill the quality
objectives
Quality Improvement: Part of quality management focused on increasing the ability to
fulfill quality requirements.
Effectiveness: Extent to which planned activities are realized and planned results achieved
Efficiency: Relationship between the result achieved and the resources used
Project: Unique process, consisting of a set of coordinated and controlled activities with
start and finish dates, undertaken to achieve an objective conforming to specific
requirements, including the constraints of time, cost and resources
Design and Development: Set of processes that transforms requirements into specified
characteristics or into the specification of a product, process or system.
Traceability: Ability to trace the history, application or location of that which is under
consideration
- the origin of materials and parts,
- the processing history, and
- the distribution and location of the product after delivery.
Concession: Permission to use or release a product that does not conform to specified
requirements. A concession is generally limited to the delivery of a product that has
nonconforming characteristics within specified limits for an agreed time or quantity of that
product.
Audit program: Set of one or more audits planned for a specific time frame and
directed towards a specific purpose
Audit evidence: Records, statements of fact or other information which are relevant to the
audit criteria and verifiable. Audit evidence can be qualitative or quantitative.
Audit findings: Results of the evaluation of the collected audit evidence against audit
criteria. Audit findings can indicate either conformity or nonconformity with audit criteria,
or opportunities for improvement.
Audit conclusion: Outcome of an audit provided by the audit team after consideration of
the audit objectives and all audit findings.