YOU MIRACLE · PUBLIC QUALITY MANAGEMENT SOP

Enterprise Quality Processes & Service Boundaries

Quality guidance previously spread across educational articles is now organized as one enterprise collaboration workflow. Five processes use consistent numbering, risk classification, evidence records and closure logic so brands can see how a project is controlled and where manufacturing services end.

Public QMS-PUB-01 · Version 1.1 · July 30, 2026

Scope and control principles

Applies to cosmetic OEM/ODM manufacturing cooperation undertaken by Yiwu Kaiqi Cosmetics Co., Ltd. within its licensed scope and confirmed contracts. Each project remains governed by its quality agreement, technical specifications, approved samples, destination market and written approvals.

One controlled versionFormula, specifications, process, packaging, label and testing requirements remain traceable by version.

Independent quality decisionsProduction, sales or schedule pressure cannot replace quality judgement; release requires an authorized quality role.

Risk firstSafety, regulatory, multi-batch or authority-related events are escalated immediately and controlled first.

Evidence-based closureVerbal explanations do not close a case; investigation, approval, execution and effectiveness are recorded.

BATCH RELEASE

No complete evidence, no releasable status

Each finished batch undergoes manufacturing and quality-record review before shipment, ending in an explicit release, rejection or pending-investigation decision.

Trigger

Starts after batch manufacturing, filling and packing are complete and required in-process and finished-product tests have been performed.

Process ownership

An authorized quality role makes the quality decision. Production, warehouse and commercial teams cannot replace release with schedule pressure.

Workflow

Verify the approved formula, process, packaging, label, specification and batch identity
Review material status, batch records, line clearance and in-process checks
Confirm required testing is complete and abnormal results are investigated
Confirm related deviations and changes are closed or their batch impact is controlled
Record the decision and control finished-product status before shipment

Outputs and records

Batch-record review, test results, linked deviations/changes, release decision, authorizer and status-change record.

Completion / decision gate

Release requires complete evidence, conforming results and resolved impact items. Insufficient evidence keeps stock quarantined or pending.

Service boundary

Factory release confirms completion against agreed manufacturing and testing requirements. It is not destination-market registration, import authorization, customer receipt acceptance or regulatory approval.

CHANGE CONTROL

Assess first, approve second, implement last

Any change that may affect quality, safety, regulation, schedule or an approved sample is assessed before implementation.

Trigger

Changes to raw materials or suppliers, formula, specification, process, equipment, environment, test method, packaging, label, site or destination market.

Process ownership

The initiating function states the reason; Quality organizes classification and approval; changes affecting customer agreements or market files require the relevant written approval.

Workflow

Submit reason, scope, proposed date and affected objects
Identify affected batches, documents, inventory, validation, stability and market files
Define testing, validation, external testing or regulatory action by risk
Obtain quality and required brand/responsible-entity approvals
Update controlled versions, implement and review initial results
Close only after the intended result is confirmed

Outputs and records

Change request, risk assessment, approvals, validation/testing, customer approval, version updates, implementation and closure records.

Completion / decision gate

An unapproved change cannot enter production. Where approval, registration or filing is legally required, that step precedes implementation.

Service boundary

The factory can assess manufacturing impact; final decisions on brand positioning, claims, market access and placing-on-market files belong to the responsible entity defined by contract and law.

COMPLAINT HANDLING

Preserve evidence before assigning responsibility

Consumer, channel and brand feedback becomes a traceable quality event, distinguishing batch, transport, use and adverse-reaction issues.

Trigger

Feedback involving appearance, odor, performance, net content, packaging function, leakage, contamination, labeling, use reaction, return or authority inquiry.

Process ownership

The website operator receives and routes the case; Quality classifies and investigates; the brand, registrant/filer, importer or local responsible person performs its market duties.

Workflow

Create a unique case and confirm contact, product, batch, market and event date
Preserve photos, video, samples, packaging, transport and storage information
Classify as general, major or potential safety event and apply interim controls
Check retains, batch/test records, deviations, changes and same-batch trends
Issue an evidence-based cause conclusion, disposition proposal and response
Escalate to CAPA, risk control, adverse-reaction reporting or recall where required

Outputs and records

Complaint intake, evidence list, classification, investigation report, communications, trend review, disposition and closure approval.

Completion / decision gate

A case may be accepted without a batch number or sample, but conclusions state the evidence limitation. Suspected safety events are not delayed by a commercial dispute.

Service boundary

Complaint validity, cost and liability follow evidence and contract. Not every complaint is automatically attributable to manufacturing. Medical assessment belongs to qualified professionals.

CAPA

Correct the issue and verify that controls work

Systemic or recurring quality issues receive corrective and preventive action, followed by an effectiveness check.

Trigger

Major or repeated complaints, recalls, deviations, OOS or adverse trends, audits, test failures, supplier issues and risk-assessment conclusions.

Process ownership

Quality assigns a coordinator for root-cause investigation; action owners are accountable for evidence and due dates; management reviews according to risk.

Workflow

Contain affected batches, materials, equipment, documents or market inventory
Define the problem, scope and adjacent batches
Investigate direct and systemic root causes with verifiable methods
Set corrective/preventive actions, owners, dates and acceptance criteria
Implement training, document, process, supplier or equipment improvements
Check effectiveness over the agreed period and reopen when criteria are not met

Outputs and records

Problem statement, root-cause evidence, risk assessment, action plan, execution evidence, linked training/change, effectiveness check and closure approval.

Completion / decision gate

Completing actions is not CAPA closure. Closure requires met effectiveness criteria and no unresolved risk.

Service boundary

CAPA reduces recurrence risk but does not promise zero risk. A single low-risk case with adequate immediate correction may remain outside CAPA when the classification rationale is recorded.

RECALL COOPERATION

Stop distribution first, then trace and control the market

When a product may present a quality or safety risk, identify scope, quarantine stock and support the responsible entity's notification, recovery and corrective work.

Trigger

Confirmed or suspected health risk, failed regulatory sampling, serious adverse-reaction signal, systemic batch defect, authority request or a recall initiated by the responsible entity.

Process ownership

The registrant/filer and destination-market responsible entity perform legal recall and reporting duties; the contract manufacturer supports investigation, production stop, traceability and disposition.

Workflow

Escalate immediately and pause related production, release and shipment
Lock product, batch, quantity, inventory, distribution and related materials
Assess risk, distribution scope, adjacent batches and markets
The responsible entity decides and performs authority, customer and consumer communications and recovery
Reconcile dispatched, on-hand, recovered, lost and disposed quantities
Complete investigation, CAPA, effectiveness review and final review

Outputs and records

Initiation decision, risk assessment, trace list, communications and recovery, reconciliation, disposal evidence, authority correspondence, CAPA and final report.

Completion / decision gate

Closure requires reconciled scope, controlled product, evidenced disposition, completed legal/contractual actions and approved follow-up measures.

Service boundary

This public process does not replace destination-market law. Recall class, recipients, reporting time, consumer remedy and cost allocation depend on applicable law, facts and contract.

Quality-event classification and escalation

Apply controls based on potential impact first, then revise classification as evidence grows. Commercial value never replaces safety risk.

A · Urgent

Suspected serious health risk, contamination spread, prohibited/restricted substance, authority involvement or multi-batch impact

Immediately stop relevant release/shipment and escalate to Quality and the destination-market responsible entity

B · Major

Batch consistency, packaging function, critical attribute, repeated complaint or potentially expanding impact

Quarantine the affected scope, prioritize investigation and assess CAPA/recall

C · General

Isolated appearance, use question, transport damage or evidence of limited impact

Record, verify, respond and trend; reclassify when escalation conditions appear

Project responsibility boundaries

Quality cooperation depends on two-way information. Manufacturing evidence does not replace the placing-on-market duties of the brand, registrant/filer, importer or local responsible person.

Role	Primary responsibility	Required input/cooperation	Does not automatically assume
Contract manufacturing and Quality	Manufacturing within licence scope, batch records, testing, release, manufacturing investigation and approved CAPA	Retains, traceability, manufacturing/testing evidence, production stop and recall support	Brand claims, import permission, market registration or every market cost
Brand / contracting customer	Product definition, approved sample, commercial version, distribution and customer communications	Accurate brief, timely approvals, batch/distribution data, returned samples and market feedback	Internal factory quality decisions or statutory registrant/filer duties
Registrant/filer/importer/local responsible person	Market compliance, placing-on-market responsibility, adverse-reaction monitoring, authority reporting and recall decisions	Regulatory assessment, market distribution, authority communication and consumer risk control	Legal duties being replaced by the factory licence
Supplier/laboratory/logistics provider	Authentic records for its material, test or transport service and investigation support	Batch, method, environment, handover and exception evidence	Whole-product liability outside its contracted service

Boundary between public workflow and controlled records

This page publishes process logic and collaboration interfaces. Internal SOPs, batch records, customer formulas, raw test data, contacts and recall lists remain controlled and are not published.

Published

Purpose, triggers and responsible roles
Inputs, main steps and decision gates
Record types and cross-entity boundaries
Applicable rules and external sources

Controlled internally

Internal form numbers, approval matrix and signature specimens
Customer formulas, suppliers, batch records and raw test data
Complainant, consumer, channel and authority contacts
Specific recall lists, quantities, costs and liability conclusions

Quality Complaint Intake, Ownership & Response SLA

Quality complaints enter through the unified API inquiry form. The website operator records and transfers them to the Quality owner. Provide the product, batch, market, event date, photographs/video and sample-retention status where possible.

Process owner: Quality (QA) at Yiwu Kaiqi Cosmetics Co., Ltd. Website operations records and routes the case but does not replace the quality conclusion.

Milestone	Target response	Explanation
Intake acknowledgement	Within 1 business day	Return a unique requestId/event number and confirm entry into the queue; list missing evidence where needed.
Risk classification	Within 2 business days	Initial A emergency, B major or C general classification. Potential safety events are escalated immediately.
Preliminary investigation plan	Within 5 business days	State the review scope for retains, batch/testing, transport and market data, plus the next update date.
CAPA/closure target	Normally within 20 business days	Complex testing, cross-border samples, authorities or supplier investigations may extend the target; reasons, interim controls and a revised date are communicated.

Submit a Quality Complaint

Redacted Record Templates & Public Index

These entries support public process review and are not raw customer or batch records. Real project records remain controlled and may be shared as a redacted summary after counterparty, relevance and confidentiality checks.

Public index	Record type	Required fields	Public status
QMS-PUB-RL-001	Batch-release summary	Anonymous product/batch code, specification version, test status, linked deviations, decision, authorising role and date	Public field template; no formula, raw result or signature
QMS-PUB-CH-001	Change-control summary	Change object, reason category, affected versions, risk review, approving role, verification and effective status	Public field template; customer and supplier data redacted
QMS-PUB-CA-001	CAPA summary	Problem statement, interim control, root-cause category, actions, owner role, due date, effectiveness and closure	Public field template; no complainant or commercial-liability conclusion

This is a public enterprise workflow. It does not replace controlled internal SOPs, an executed quality agreement, product technical files or applicable legal advice.

Regulatory basis and use

The workflow reflects Chinese cosmetics manufacturing-quality and post-market risk-control requirements. Cross-border projects also require destination-market and contractual review.

NMPA Good Manufacturing Practice for Cosmetics Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics Provisions for Administration of Adverse Reaction Monitoring of Cosmetics

Put quality interfaces into the project before an issue occurs

State the sales market, product category, expected quantity and quality-document needs in your inquiry. A formal quality agreement can then define response times, sampling, acceptance, complaints, recall and cost boundaries.

Submit project and quality requirements