Audit & Inspection

For any quality control aspect there are basically three aspects areas quality primarily any quality evaluator used to focused for any products & services

·????????Quality of design

·????????Quality of conformances

·????????Quality of performance.

Now in the industry we are sometimes mixed understanding on inspection & audit .

Below discussion will clarify about inspection & audit

What is inspection in quality control: -

An inspection is an activity such as?measuring, examining, testing or gauging one or more characteristics of a product and comparing the results with specified requirements?in order to establish whether conformity is achieved for each characteristic and determine the quality level of the products.

Quality inspection has no feedback loop.

Different aspect of inspections:

·????????Product Inspection:

·????????Process Inspection:

·????????Inspection Analysis:

What is quality audit?

As per standard definition audit is “systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.”

Now to clarify the more we have to understand the terms

Objective evidence: - Data supporting the existence or verity of something.

Audit criteria: - Set of requirements used as a reference against which objective evidence is compared

Requirements--need or expectation that is stated, generally implied or obligatory

In short, the systematic examination of an organization's quality management system (QMS). A quality audit is typically carried out by an internal or external quality auditor or audit team.

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Types of quality audit?

·????????First party / internal quality system audit: - Basically how internal quality maintained by the organization like tools & method used & their calibration and traceability.

·????????2nd party / external service provider audit: - Like for vendor development, Product.

·????????3rd party / regulatory / Certification/ accreditation / Statutory audit): - This type audit conducted to verify compliance with a specific set of regulations or standards. practices are examined, and the data collection process is reviewed to identify possible areas of nonconformance.

·????????Safety Audit: - linked with safety of employee & worker by raw material & operational health & safety impact. (ISO 45001:2018)

·????????Environmental Audit: - Guide companies create work place or operational activities which impact less to the environment by helping to identify areas operational aspect & their environmental impact.

·????????Risk assessment Audit: - Identifies potential operation & business uncertainties, then categorizes each uncertainty so preventative measures can be put into place. An audit of this type helps companies put an effective risk mitigation strategy into action.

·????????Competence & team motivation audit: - When skills management re-qualifications are required. auditors evaluate changes to processes, new competency required training provide, past activity, nonconformance, and conformity inspections of operator accepted product as part of the re-qualification.

·????????Facilities audit :- this audit talk about quality concerns of a corporation’s assets.

·????????Design control audit: - This audit conducted within highly regulated industries to ensure that manufacturers follow a formalized process that results in an end-product that meets acceptable quality and safety standards and adequately serves user needs.

·????????Method Validation Audit: - A method validation audit is used by the FDA or other regulatory authorities to ensure that the analytical test methods used in the manufacturing process are standardized, reproducible and documented. This methodology is applied to testing that requires consistency and accuracy, usually in cases of products manufactured for human use.

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Purpose or objectives of quality audit?

To verify the compliance of the department/organization to the defined Quality Management system and eh requirements of ISO 9001:2015.

What are the principles of audits?

·???????Integrity

·???????Fair presentation

·???????Due professional care

·???????Confidentiality

·???????Independence

·???????Evidence-based approach

·???????Risk-based approach

What is the procedure or steps of audit? How auditing Done?

·????????Define the purpose.

·????????Define the scope.?

·????????Determine the audit team resources to be used.?

·????????Identify the authority for the audit..

·????????Identify the performance standards to be used.?

·????????Develop a technical understanding of the processes to be audited.?

·????????Contact those to be audited.?

·????????Perform an initial evaluation of lower-tier documents to higher-level requirements.?

·???????Develop written checklists of the data needs.?

Principles of auditors look into your management system?

·???????customer focus

·???????Leadership

·???????Process approach

·???????Improvement

·???????Evidence-based decision making

·???????Relationship management

In summary now we have the clarity of Audit & inspection