The document outlines a 10 stage quality management system implementation plan. It involves gap analysis, developing action plans, training, drafting documentation like quality manuals, implementing processes, and conducting internal and external audits. Various stakeholders are involved at each stage, including quality managers, directors, department heads, and employees. The goal is to achieve API Q1 certification by developing the necessary documents and addressing compliance requirements.
The document outlines a 10 stage quality management system implementation plan. It involves gap analysis, developing action plans, training, drafting documentation like quality manuals, implementing processes, and conducting internal and external audits. Various stakeholders are involved at each stage, including quality managers, directors, department heads, and employees. The goal is to achieve API Q1 certification by developing the necessary documents and addressing compliance requirements.
The document outlines a 10 stage quality management system implementation plan. It involves gap analysis, developing action plans, training, drafting documentation like quality manuals, implementing processes, and conducting internal and external audits. Various stakeholders are involved at each stage, including quality managers, directors, department heads, and employees. The goal is to achieve API Q1 certification by developing the necessary documents and addressing compliance requirements.
The document outlines a 10 stage quality management system implementation plan. It involves gap analysis, developing action plans, training, drafting documentation like quality manuals, implementing processes, and conducting internal and external audits. Various stakeholders are involved at each stage, including quality managers, directors, department heads, and employees. The goal is to achieve API Q1 certification by developing the necessary documents and addressing compliance requirements.
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Field Phas Sub phases Input Output No of Duration on-site Off Site Concerned Steering
e Data Data Experts (Hours) mission mission staff committee
( Vegas Days Days CG) API Q1 Complete Directors Gap Analyis Compliance QMR Stage Matrix 2 8 3 0 Departments 2 (Diagnosis) Compliance Heads Matrix Employers Complete inventory of Actions plan Compliance compliance actions QMR Matrix Direction Stage Complete Prsentation of 2 8 4 2 QMR 3 Restitution Compliance gaps Concerned Matrix Departments Heads Quality Direction management QMR training, API Q1 Departments , SPEC 10A 1 8 5.5 0 Heads Stage Audit Training, Employees 4 API Q1 API depending on Tranning Group will be Q1 the joined plan formed during the project Execution Standard Training in Existing documents writing document Quality manual operational format Processes Stage documents Procedures 5 API Instructions of 3 8 5 40 QMR requirements work, technical to specifications Departmental and operating Heads Stage modes 7 Records and dashboards support for Approved QMR drafting documents 5 3 3 Departmental operational Heads documents employers Writing the Quality manual 0 0 QMR quality manual written in English 3
Following up the post audit setting up Internal audit actions QMR internal audit procedure Qualification of processes API Internal audit the internal Q1 planning auditors Stage Management Process Management 2 8 2 0 Direction 8 review process review review report QMR Performance Decision on indicators quality Normative management requirements
8 QMR Pre audit API Q1 Audit report 3
Definition of Audit report Actions plan
Stage compliance 3 8 9 actions Applicant forms in NO of Days to To Preparation of Required English Decided Upon Out of the documents documents by the Quality manual in 3 8 Stage 8 Stage to be provided API English 11 to the API Compliance matrix in english Plan elaboration Inventory of Detailed plan actions to be (who did what for Stage implemented for when) 1 API spec 10A Identification of the certification needed trainees To Following up of 2 8 3 0 the Detailed plan General Stage implementation Improvements 4 /planned
Process Interlinking 2 2 2 API Mapping manufacturing Spec process to 10A Standard Training in the Format of existing documents drafting of documents Product professional Requirements description documents API Q1 sheets Stage Quality 5 document 3 8 2.5 0 Methods to evaluate and control the product conformity in the laboratory and the API Support for the Documents to be Approved 5 5 5 drafting of approved documents professional documents Pre Pre audit API spec 10A Audit report integrated integrated audit definition of Audit report Actions plan integrated integrated QMS compliance 2 4 actions preparation of Required Applicant forms in integrated integrated the documents documents by the English to be provided API to the API
