ISO9001 System Document Package (18) | Identification and Traceability Control Procedure (8.5.2)

Document Description

This procedure corresponds to clause 8.5.2 "Identification and Traceability" of ISO 9001:2015. It is a critical supporting procedure for the product realization process (COP). Its purpose is to manage the effective identification of products, inspection status, and unique identifiers (batch number/serial number/trace number) throughout the production and service provision processes. This prevents product confusion, the misuse or unintended release of nonconforming products, and enables quick identification and isolation of problematic batches in the event of quality issues, facilitating recall or disposition. This procedure applies to various manufacturing enterprises, including mechanical processing, electronic assembly, injection molding, food, chemical, pharmaceutical, and building materials industries. It also applies to service and trading enterprises with batch management requirements. Small and medium-sized enterprises (SMEs) can choose between "batch traceability" or "individual traceability" based on product complexity, but the establishment, transfer, and recording of identifiers must form a closed loop. This procedure is used in conjunction with the "Production Process Control Procedure," "Nonconforming Product Control Procedure," "Product Protection Control Procedure," and "Product Release Control Procedure."

1. Purpose

To standardize the management activities of product identification, inspection status identification, and traceability, achieving the following objectives:

1. Throughout the product realization process, use appropriate methods to identify products to prevent confusion between different types, specifications, and batches.
2. Clearly define the inspection status of products (awaiting inspection, conforming, nonconforming, awaiting disposition) to prevent the misuse or unintended release of uninspected or nonconforming products.
3. For products with traceability requirements, establish and maintain unique identifiers to enable forward traceability from raw materials to delivery and backward traceability from customer feedback to raw materials.
4. Ensure that identification-related records are genuine, complete, and clear, and correspond one-to-one with the physical products, providing a basis for product release, nonconforming product disposition, and continuous improvement.

2. Scope of Application

This procedure applies to the entire process of product identification and traceability management from the procurement of materials into the factory, production processing, inspection and testing, packaging and storage, to product delivery. This includes, but is not limited to:

1. Identification and status management of raw materials, purchased components, outsourced parts, and packaging materials.
2. Identification and status management of work-in-progress and semi-finished products during their flow through various processes.
3. Status identification management of finished products, items awaiting inspection, conforming items, nonconforming items, and items requiring rework or repair.
4. Batch/individual traceability management for products that must be traced due to customer requirements (as specified in contracts, orders, or technical agreements) or legal and regulatory requirements (such as food, pharmaceuticals, pressure vessels, and automotive parts).
5. Identification and isolation management of samples, prototypes, test items, and scrap items.

The following scenarios should also follow this procedure: customer-provided property (managed according to the "Customer Property Control Procedure," but the identification method applies to this procedure); identification of outsourced processed products (implemented by the supplier according to this procedure, with the company responsible for specifying and verifying the requirements in the contract).

3. Responsibilities

4. Work Procedures

4.1 Identification Planning

1. The Technical Department, during the product design or process planning stage, determines the identification method based on product characteristics, customer requirements, and legal and regulatory requirements, and specifies it in the process documents or control plans:
   • Identification methods include: labels/signs, coding, barcodes/QR codes, color codes, area identifiers, process cards/work orders, etc.
   • Identification content generally includes: product name, specification model, batch number/furnace number/date code, quantity, supplier name (for material identification), inspection status, etc.
   • Identification location: on the product itself, packaging unit, transfer container, or storage card, ensuring it is prominent, durable, and does not affect product quality or appearance.
2. For products with traceability requirements, the Technical Department and Quality Department jointly develop the "Product Traceability Plan," specifying the traceability scope (to raw material batches or individual items), traceability coding rules (e.g., "production date + line code + shift code + serial number" such as "20260827A1-001"), and the carriers and retention requirements for traceability records.
3. Once the identification method is determined, any changes must be reviewed by the Technical Department and co-signed by the Quality Department to prevent confusion between old and new identification methods.

4.2 Product Identification (Identity Identification)

1. When procurement materials are received into the warehouse, the warehouse manager verifies that the materials match the "Purchase Request" or delivery note, then establishes an identifier based on the material code, noting the material name, specification, quantity, supplier, receipt date, and batch number, and enters the information into the ledger or ERP system.
2. During material requisition, the material handler records the batch information on the "Requisition Form"; the workshop requisitions and uses materials by batch, prohibiting mixed batch usage (special cases requiring mixed batches must be approved by the Quality Department and recorded).
3. During production, work-in-progress flows with the "Process Card/Work Order," which specifies the product name, specification, process flow record, operator, inspection record, and batch number; after each process, the operator signs the work order to confirm.
4. During finished product packaging, the packaging worker attaches a finished product label to the packaging unit (box, pallet), noting the product name, specification, quantity, batch number, production date, and inspection status; when shipping, the warehouse establishes a "Shipping Record" and registers the shipping date, customer name, batch number, and quantity.
5. Identifiers should remain clear and secure; if they fall off, become blurred, or are damaged during use, the responsible position must re-verify the physical information and reapply the identifier, prohibiting the reapplication based on memory.

4.3 Inspection Status Identification

1. All products must be under a clear inspection status identifier before inspection is completed. The status is divided into four categories: awaiting inspection, conforming, nonconforming, and awaiting disposition (concession acceptance/rework/repair/scrap review).
2. Methods for inspection status identification:
   • Awaiting inspection: placed in the "awaiting inspection area" (area identifier or yellow sign) or labeled with a "awaiting inspection" tag.
   • Conforming: after passing inspection, the inspector attaches a green "conforming" label/stamp or signs off in the inspection column of the work order.
   • Nonconforming: the inspector attaches a red "nonconforming" label and immediately moves the item to the "nonconforming product isolation area" (red area) to prevent misuse.
   • Awaiting disposition: labeled with a "awaiting disposition" sign (yellow) and awaits review conclusions; no department may use or transfer the item during the review period.
3. Changes to inspection status identifiers can only be made by the inspector; no one may alter, deface, or replace inspection status identifiers without authorization. If a mismatch between the identifier status and the physical product is discovered during production, the flow must be immediately stopped and reported to the Quality Department.
4. Products that have been reworked or repaired must be re-inspected, and the inspector updates the status identifier based on the re-inspection results, retaining the original nonconforming record.

4.4 Traceability Management

1. Establishing the traceability chain: using the batch number (or serial number) as the main thread, the following records are associated to form a complete traceability chain:
   • Raw material batches: purchase order number, supplier, incoming inspection record, and storage batch number.
   • Production process: material input record, process flow record (work order), process inspection record, equipment/tooling usage record, and operator.
   • Finished products and delivery: finished product batch number, factory inspection record, packaging and shipping record, customer name, and delivery date.
2. Example of traceability coding rules: finished product batch number = production date (YYYYMMDD) + line code + shift code + serial number, such as "20260827A1-001"; raw material batch number = supplier code + arrival date + serial number. The company can define its own rules based on product characteristics, but they must be unique, stable, and readable.
3. For products with traceability requirements, records must flow with the physical items at each stage, ensuring "item to record." Records must be filled out promptly, accurately, and completely, without pre-filling or post-filling.
4. The Quality Department organizes at least one traceability drill annually (simulating a customer complaint scenario, tracing back from the finished product batch to the raw material batch and all process records) to verify the completeness and timeliness of the traceability chain, and records the drill results. If a break in the chain is discovered during the drill, corrective actions are implemented according to the "Nonconforming and Corrective Action Procedure."
5. If the traceability requirements for export products or legally mandated traceable products (such as food, pharmaceuticals) cannot be met, the batch must not be released and should be reported to the management representative for review.

4.5 Transfer and Protection of Identifiers

1. When products are transferred to the next area/process, the identifier must be transferred with the physical item; during repackaging, unpacking, or changing packaging, the identifier must be replaced, ensuring consistency between old and new identifiers.
2. If the identifier is separated from the product (e.g., attached to a transfer container), the container must be cleared of old identifiers when the product inside is emptied or replaced to prevent misidentification.
3. The warehouse manages batches according to the "first-in-first-out" principle, ensuring that the storage card and physical identifier are consistent. Regular checks (at least once a month) are conducted to verify the consistency of accounts, items, and cards.

4.6 Handling of Identifier Anomalies

1. If an identifier is found to be missing, incorrect, blurred, or in a mismatched state, the responsible department must immediately stop the flow of the related product and report to the Quality Department.
2. The Quality Department organizes a verification of the affected batches: if the identity and status can be confirmed through records and physical information, the identifier is re-applied or corrected, and the flow is resumed; if unable to confirm, the product is re-inspected according to the "Nonconforming Product Control Procedure."
3. If an identifier error leads to the release or confusion of nonconforming products, corrective actions are initiated according to the "Nonconforming and Corrective Action Procedure," analyzing the root cause (identifier method, personnel training, process loopholes, etc.) and tracking verification.

4.7 Flowchart (Text Version)

Start → Identification Planning (method/content/traceability rules) → Material Inbound Identification → Requisition and Batch Registration → Process Flow with Work Order → Inspection and Status Update (conforming/nonconforming/awaiting disposition) → Nonconforming Product Isolation → Finished Product Packaging → Storage/Shipping Batch Registration → Archiving and Retention of Traceability Records → Regular Verification and Traceability Drills → End.

Abnormal Branch: Identifier Missing/Damaged → Stop Flow → Quality Department Verification → Confirm Identity and Reapply Identifier or Re-inspect → Record Disposition Results.

4.8 Retention of Identification Records

Identification and traceability-related records (work orders, inspection records, requisition forms, shipping records, traceability drill records, etc.) are managed according to the "Record Control Procedure." The retention period is generally the product lifecycle plus 1 year, or as required by the customer or regulations. Electronic records should be backed up regularly to prevent loss.

5. Related Records

6. Related Documents

1. Document Control Procedure
2. Record Control Procedure
3. Production Process Control Procedure
4. Nonconforming Product Control Procedure
5. Product Protection Control Procedure
6. Product Release Control Procedure
7. Customer Property Control Procedure
8. Procurement and External Provision Control Procedure
9. Nonconforming and Corrective Action Procedure

Usage Instructions

1. How to Modify According to Actual Corporate Conditions

1. Identifier Method Selection: For high-value, high-safety-risk products (such as automotive parts, medical devices, pressure vessels), it is recommended to use individual unique identifiers (serial number/QR code). For low-value, high-volume products (such as general hardware, packaging materials), batch identification is sufficient, avoiding unnecessary coding to save costs.
2. Traceability Depth: For companies with low traceability requirements, traceability can be limited to the "raw material batch + production date" level. For industries with legal and regulatory traceability requirements (such as food, pharmaceuticals), traceability must extend to the batch number of the raw material supplier or even the origin, and the traceability plan must be separately compiled and approved by the management representative.
3. Coding Rules: Design coding rules based on the company's ERP/MES system capabilities, aiming to align with the system batch numbers to avoid "two sets of accounts." For companies without information systems, manual coding using "date + serial number" is acceptable, but must be registered in the ledger.
4. Organizational Adaptation: In small enterprises, the Quality Manager's responsibilities can be combined with those of the Quality Supervisor. The identification responsibilities of the warehouse and workshop can be adjusted according to actual positions, but the three stages of "identifier implementation—inspection status confirmation—record archiving" must be clearly assigned.
5. Adaptation for Service Enterprises: Convert "product identification" to "service ticket/work order number," and "batch traceability" to "service personnel + service time + material batch" associated records, which also fit the framework of this procedure.

2. Audit Focus Points

1. On-site Inspection: Auditors typically randomly select a work-in-progress or finished product and request a trace back to the raw material batch, inspection records, operator, and shipping destination—this is a "traceability drill." The company should ensure that the complete traceability chain can be provided within 30 minutes.
2. Effectiveness of Inspection Status Identifiers: Are nonconforming and awaiting inspection items physically isolated from conforming items? Can only the inspector change the status identifier? There should be no "unidentified products" on-site.
3. Consistency Between Identifiers and Records: Do the label information, work orders, inspection records, and ledgers match? Are there any cases of "records without items" or "items without records"?
4. Readability and Retention of Traceability Records: Are the records clear, retained for the specified period, and easily searchable? Are electronic records backed up?
5. Identification in Special Processes: Are the batch identifiers for heat treatment, electroplating, and other special processes complete and associated with process parameter records?

3. Common Errors

1. Equating "identification" with "labeling": Only product identification is done, without inspection status identification, or the status identifier is changed by the operator, leading to the unintended release of nonconforming products.
2. Traceability Chain Breakage: Raw material batches are not registered during material input, or work orders are lost during the process, making it impossible to trace back to the source during drills.
3. Separation of Identifiers and Physical Items: Identifiers are attached to containers, and when the container is repackaged with other products, the identifiers are not replaced, causing batch confusion.
4. Arbitrary Reapplication of Identifiers: Identifiers are reapplied based on memory without verification by the Quality Department, potentially masking real quality issues.
5. Post-filling of Traceability Records: Records are filled out on the spot during audits, leading to discrepancies between record dates and production dates, resulting in nonconformities.
6. Over-tracing: All products are traced individually, leading to high costs and low efficiency, and making on-site implementation difficult. Traceability depth should be reasonably determined based on product risk and customer requirements.

The three essentials of identification: product identification, status identification, and traceability chain, none can be missing.

Knowledge code: 2.3.1

Version: v20260809

Author: Quality Think Tank Quality Think Tank is dedicated to providing systematic professional knowledge, methodologies, and practical tools for quality management practitioners, helping companies continuously improve their quality capabilities.