Quality and continuous improvement

Specialist agents · 25

• Document controlanalysis

  Monitors versions, review dates and validity of quality system documents (manuals, instructions, records) and detects obsolete copies in use, expired documents or documents with no owner. Analyzes and flags; does not change content.

• Procedure designproposal

  Drafts or updates work instructions and quality procedures with steps, owners, records and acceptance criteria, based on incidents and validated changes. Proposes drafts for approval.

• Control planningproposal

  Designs the control and inspection plan: what is checked, how often and with what sampling, adjusted to risk and defect history. Proposes new controls, frequency changes or removal of controls that add no value.

• Non-conformity managementproposal

  Records nonconformities and findings with description, scope, affected product or batch, severity and immediate containment, avoiding duplicates and ensuring traceability through to closure.

• Root cause analysisanalysis

  Formulates root-cause hypotheses (5 whys, Ishikawa, recurring patterns) from nonconformity and inspection evidence, stating which data is missing to confirm them. Does not propose changes.

• Corrective actionsproposal

  Turns accepted causes into corrective and preventive actions with owner, deadline and effectiveness criterion, and tracks them to close on time and reopen overdue ones.

• Audit preparationproposal

  Compiles evidence, records and open items for internal, customer or certification audits, identifies gaps against the standard or requirement and prepares the preparation schedule.

• Supplier qualityanalysis

  Links quality incidents to suppliers and supply batches, assesses their performance (defects, deliveries, response to claims) and flags suppliers needing an audit or improvement plan.

• Improvement validationproposal

  Validates whether an improvement works by comparing before and after results against defined criteria, separating real improvement from fluctuation or adverse effect, and recommends keeping, extending or withdrawing it.

• Quality claimsproposal

  Classifies customer quality complaints and links them to product, batch and originating process, detects repeats and proposes opening nonconformities or source-level control adjustments.

• QMS and ISO certificationproposal

  Designs and maintains the quality management system: scope, policy, objectives and management review agenda. Prepares the relationship with the certification body and proposes QMS adjustments when objectives change or deviations appear.

• Sector quality regulationsproposal

  Identifies the quality standards and regulations applicable to the sector (ISO 13485, IATF, HACCP, FDA, CE, GMP) and translates them into verifiable internal requirements. Proposes the procedure and control changes needed to cover each requirement.

• Statistical process controlproposal

  Defines AQL sampling plans, control charts and capability studies (Cp/Cpk) from inspection data. Detects out-of-control or incapable processes and proposes adjustments to sampling frequency and size.

• Metrology and calibrationproposal

  Manages the calibration plan for measuring equipment and MSA/R&R studies. Flags overdue or soon-to-expire calibrations and proposes scheduling verifications or measurement system studies.

• Quality risk managementproposal

  Builds and updates FMEA and quality risk matrices to prioritize controls and preventive actions. Recalculates priority indices when failures, process changes or complaints appear.

• Internal auditproposal

  Plans the annual internal audit program based on risk and prior results, prepares checklists and drafts findings reports. Proposes the schedule and scope of each audit.

• Supplier qualificationproposal

  Evaluates, approves and audits suppliers, and manages PPAP and development plans. Proposes approval, conditional status or removal based on performance and audits.

• Traceability and recallsproposal

  Ensures lot-level traceability of product and raw materials, and coordinates alerts, holds and recalls with authorities and customers. Verifies traceability coverage and proposes the response procedure for an incident.

• Lean and Six Sigma improvementproposal

  Proposes and structures improvement projects using Lean, Six Sigma, kaizen and A3, prioritized by impact and effort. Defines scope, baseline and target for each project from already analyzed causes.

• Quality KPIs and cost of qualityanalysis

  Calculates quality indicators and the cost of poor quality (prevention, appraisal, internal and external failure) for management review. Explains variations and highlights where avoidable cost is concentrated.

• Design and launch qualityproposal

  Integrates quality requirements into new product development through APQP and design verification and validation. Proposes quality gates, control plans and approval criteria for launches.

• Software QA and releasesproposal

  Defines acceptance criteria, test strategy and software release quality metrics (escaped defects, incidents, regressions). Proposes quality gates and test adjustments before each release.

• SOC 2 and ISO 27001 readinessproposal

  Prepares controls, evidence and timeline for SOC 2 and ISO 27001 audits required by enterprise customers. Detects controls without current evidence and proposes the evidence collection plan and necessary procedure changes.

• Quality training and cultureproposal

  Detects competence needs from nonconformities and procedure changes, plans quality procedure training and measures quality culture. Proposes training plans and effectiveness checks.

• Lessons learnedproposal

  Consolidates learnings from nonconformities, complaints and projects into a searchable base and propagates them to similar processes and areas. Proposes updating procedures and controls where the same cause may recur.