Quality management process templates

Quality management process templates in this category

• Change control process flowchart — A change control process flowchart covering request, impact assessment, CAB approval, implementation, verification and closure, plus an emergency route.
• CAPA process flowchart (corrective and preventive action) — A CAPA process flowchart in five swimlanes: log and grade the issue, contain it, investigate the root cause, correct and prevent, then verify before closure.
• Deviation management process flowchart — Deviation management process flowchart: detection, containment, classification, impact assessment, investigation, batch disposition, CAPA and closure.
• Document control process flowchart — A document control process flowchart with Author, Reviewer, Approver, Document controller and End user lanes: drafting, approval, issue and periodic review.
• Quality complaint process flowchart template — A quality complaint process flowchart across five lanes: logging and acknowledgement, safety and reportability checks, investigation, remedy, CAPA and closure.
• Quality control process flowchart — Quality control process flowchart: sampling per plan, incoming, in-process and final inspection, testing against specification, and nonconforming control.
• Root cause analysis process flowchart — Root cause analysis process flowchart covering problem statement, containment, evidence, 5 Whys and fishbone, cause verification and handover into CAPA.
• Risk assessment process flowchart — Risk assessment process flowchart covering scope and criteria, risk identification, likelihood and impact scoring, control effectiveness, the four treatment options and the review cycle.
• Document approval workflow decision tree template — A document approval workflow decision tree: editorial or substantive change, mandatory reviewers by document type, second approver, and training on release.
• Root cause analysis flowchart (decision tree template) — A root cause analysis flowchart drawn as a decision tree: nine tests route a problem to 5 Whys, a fishbone, a fault tree, escalation or a documented stop.
• Product recall process flowchart (recall vs withdrawal) — Product recall process flowchart: health risk assessment, recall or withdrawal, classification, regulator and public notice, retrieval, effectiveness check.
• Policy review and approval process flowchart (trigger to attestation) — Policy review and approval process flowchart: calendar or event trigger, owner confirmation, gap analysis, consultation, legal and employee-representative review, tiered approval, publication and attestation.
• Batch release process flowchart (QP certification to despatch) — Batch release process flowchart for GMP manufacture: batch record review, analytical testing, OOS and deviation closure, QA review, QP certification, disposition, certificate of analysis and stock unblocking.
• Supplier corrective action process flowchart (SCAR, issue to closure) — Supplier corrective action process flowchart (SCAR): screen the failure, issue with deadlines, contain stock on both sides, prove root cause and escape point, verify effectiveness over agreed lots, then close or escalate.
• Document version control template — A document version control template showing how a draft moves from minor versions (0.1, 0.2...) through review, gets a whole number only at formal approval, and how later revisions supersede the version they replace.
• SOP revision history template — Use a filled SOP revision history example with version, date, change, author, approver and effective date, alongside an editable revision-control workflow.
• Document revision log template — A document revision log template, also called a change log: track a change to any controlled document from request through a pending entry, implementation and verification to a closed, dated record.
• Document change control workflow flowchart — A document change control workflow flowchart covering minor/major classification, reviewer impact assessment, approval, version stamping, distribution list updates and formal supersession of the previous version.
• SOP change control process flowchart — A SOP change control process flowchart with Requester, Process owner, Safety or QA reviewer, Approver and Trained operators lanes: safety-critical routing, QA-gated approval and mandatory hands-on retraining before go-live.
• Medical device complaint process flowchart (intake to vigilance report) — Medical device complaint process flowchart template: complaint definition check, safety screen, US and EU vigilance reportability, device return and evaluation, root cause, field action or CAPA, final report and trending.
• CAPA Gantt chart template for corrective and preventive action plans — An editable CAPA Gantt chart: containment, evidence and root cause, an approved action plan, corrective and preventive actions, an effectiveness check window and closure review, with dependencies and milestones.
• Regulatory submission Gantt chart template with response window — An editable regulatory submission Gantt chart: gap analysis, parallel module authoring, internal review, publishing, submission and a window for answering questions, with dependencies and milestones.
• Computer system validation Gantt chart template with IQ, OQ and PQ — An editable computer system validation Gantt chart: validation plan, requirements, risk, configuration, IQ/OQ/PQ scripts written alongside the build, deviations, traceability review, report and release.