ISO9001 System Document Package (21) | Product Release Control Procedure (8.6)

Document Description: This procedure corresponds to clause 8.6 "Release of products and services" of the ISO 9001:2015 standard. It is the concluding phase of the operational processes (Chapter 8), determining at which point, by whom, based on what criteria, and in what manner products are approved to enter the next phase or be delivered to customers. Its core functions are threefold: first, to solidify the principle that "products must be inspected and found conforming before release," preventing unverified products from reaching customers; second, to provide a controlled "exceptional release" channel for scenarios where the inspection cycle conflicts with production rhythm, avoiding delays in delivery due to rigid enforcement; third, to enable batch traceability through release records, allowing for quick identification of affected batches in case of quality fluctuations. This procedure applies to all production, manufacturing, assembly, and service companies that have established a quality management system (QMS), especially those with multi-variety, multi-batch production and urgent delivery requirements. The effectiveness of release control directly determines whether the QMS can maintain the "product conformity" defense line and is one of the key clauses reviewed during certification audits.

1. Purpose

To standardize the release management of products at various stages within the company, clarify release criteria, release authority, release methods, and record requirements, ensuring that only products and services that meet specified requirements are transferred to the next process or delivered to customers. For special cases where planned verification activities are incomplete but release is necessary, a controlled exceptional release process is implemented to prevent nonconforming products from being released unintentionally while meeting customer delivery requirements.

2. Scope of Application

This procedure applies to the release of purchased products (including raw materials, purchased components, and results of outsourced processes), the release of intermediate products during production, the final release of finished products, and the management of all exceptional releases (emergency releases, concessions).

3. Responsibilities

4. Work Procedures

4.1 General Principles for Release

4.1.1 The company implements a "three-stage, two-authority, one-exception" management system for product release:

• Three stages: incoming release, process release, final release of finished products.
• Two authorities: inspectors release products according to inspection procedures; authorized release persons approve exceptional releases based on their authority levels.
• One exception: products can be exceptionally released only after authorization if the planned verification activities are not fully completed.

4.1.2 The basic premise for release is that "the planned arrangements have been fully completed," meaning all specified inspection, testing, and verification activities for the stage have been completed and the results meet the acceptance criteria. Any release must be supported by written or electronic records, ensuring "no release without records, no release of nonconforming products, and no release without authorization."

4.1.3 Release criteria are formulated by the Technical Department based on product standards, customer requirements, regulatory requirements, and process documents. These criteria, once approved, serve as the sole basis for release judgments. Any changes to the criteria must be managed according to the "Document Control Procedure."

4.2 Release of Incoming Products

4.2.1 After purchased products arrive, the warehouse verifies the consistency of the delivery note, purchase order, and physical items (product name, specifications, quantity, batch) and processes a temporary receipt, placing the items in the "pending inspection" area and marking them as "pending inspection."

4.2.2 The incoming quality control (IQC) inspector conducts inspections according to the "Incoming Inspection Procedure" and the corresponding inspection standards, filling out the incoming inspection record. The judgment results are:

• Conforming: sign "conforming" on the inspection record, notify the warehouse to process warehousing, and change the identification to conforming.
• Nonconforming: handle according to the "Nonconforming Product Control Procedure" and isolate the products in the nonconforming area.

4.2.3 When urgent production needs arise and there is not enough time to complete all inspection items, the using department can fill out an "Exceptional Release Application Form," which must be approved by the head of the Quality Inspection Department to process an emergency release. Emergency-released products should be clearly marked and recorded separately to ensure traceability. After release, all specified inspection items must still be completed. If the inspection results are nonconforming, the products must be immediately recalled and handled according to the "Nonconforming Product Control Procedure." Key characteristics (such as safety and regulatory items) cannot be emergency-released.

4.3 Release of Process Products

4.3.1 After the completion of processing in a given operation, the operator conducts a self-inspection according to the process documents and fills out the self-inspection record. The first piece must be specially inspected by an inspector and found conforming before batch production can proceed.

4.3.2 For operations with designated process inspection points, the process inspector conducts patrols or special inspections according to the "Process Inspection Procedure," filling out the process inspection record. If the inspection is conforming, the inspector signs the flow card/work order, allowing the product to move to the next operation. If the inspection is nonconforming, the product is immediately marked, isolated, and handled according to the "Nonconforming Product Control Procedure."

4.3.3 When the next operation receives products from the previous operation, it should verify the release signature and identification on the flow card/work order. Products that have not been released must not be used or processed.

4.4 Final Release of Finished Products

4.4.1 After finished products are completed, the Production Department issues a "Finished Product Warehousing/Inspection Form" and submits it to the Quality Inspection Department along with the work order and process inspection records.

4.4.2 The finished product inspector conducts a full inspection (including packaging and identification checks) according to the "Finished Product Inspection Procedure" and product acceptance standards, filling out the finished product inspection record and issuing an inspection conclusion.

4.4.3 If the product is found conforming and all specified inspection and testing items are completed, the inspector signs the inspection record and the "Product Release Form," and the warehouse processes the warehousing, allowing the finished product to be delivered to the customer. If the product is found nonconforming, it must be handled according to the "Nonconforming Product Control Procedure" and not released.

4.4.4 The final release of finished products should only occur after all planned verification activities (including customer-required inspection items and regulatory-mandated type tests) are fully completed. Products involving mandatory certification (such as CCC, production permits) must also meet the factory release conditions specified by relevant regulations.

4.5 Exceptional Release (Emergency Release/Concession Release)

4.5.1 Exceptional release applies to the following scenarios:

• Emergency release: inspection/verification activities are not fully completed, but production or delivery is urgently needed.
• Concession release: a product is found to not meet a certain requirement, but after review, it is confirmed that this does not affect the product's performance, safety, or regulatory compliance, and the customer (when applicable) agrees to accept it.

4.5.2 Application and approval for exceptional release:

• The responsible department fills out an "Exceptional Release Application Form," noting the product name, specifications, batch, quantity, nonconformities/uncompleted items, reasons, proposed release direction, and corrective actions.
• The Technical Department assesses the technical risks and signs off on the application.
• General exceptional releases are approved by the head of the Quality Inspection Department. Concessions involving customer requirements, regulatory requirements, or safety characteristics must be approved by the Management Representative/General Manager and require prior written customer consent (retain evidence of customer agreement).
• After approval, the exceptionally released products must be marked with "exceptional release" and tracked in a dedicated ledger.

4.5.3 Exceptional release does not alter the principle that products must ultimately meet all requirements. After release, the verification or disposition activities must continue. If the verification is nonconforming, the recall procedure must be immediately initiated and the product handled according to the "Nonconforming Product Control Procedure."

4.6 Release Records and Traceability

4.6.1 All release activities (normal and exceptional releases) must be recorded, including: incoming/process/finished product inspection records, product release forms, exceptional release application forms and approval comments, and customer consent evidence for concessions.

4.6.2 Release records should include the product batch/number, release criteria (inspection report number or criteria name), release conclusion, release signature, and date, ensuring that each batch of released products can be traced back to the corresponding inspection evidence and responsible person.

4.6.3 Release records are managed according to the "Record Control Procedure," with retention periods specified in the record list (generally not less than the product lifecycle or regulatory requirement period).

4.7 Flowchart (Text Version)

Product Completion (Incoming Arrival/Operation Completion/Finished Product Completion)
        │
        ▼
Temporary Receipt/Pending Inspection, Mark "Pending Inspection"
        │
        ▼
Inspector Conducts Inspection/Verification According to Criteria
        │
        ├── All Items Completed and Conforming ──► Sign Release (Inspection Record + Release Form) ──► Warehousing/Transfer/Delivery
        │
        ├── Nonconforming ──► Mark and Isolate ──► Handle According to the "Nonconforming Product Control Procedure"
        │
        └── Verification Incomplete/Mild Nonconformity (Urgently Needed) ──► Fill Out "Exceptional Release Application Form"
                                                   │
                                                   ▼
                              Technical Department Risk Assessment → Authorized Person Approval (Customer/Regulatory Consent Required)
                                                   │
                                                   ▼
                              Mark "Exceptional Release" → Release and Track → Continue Verification → Nonconforming Recall

5. Related Records

6. Related Documents

1. Quality Manual
2. Nonconforming Product Control Procedure
3. Identification and Traceability Control Procedure
4. Monitoring and Measurement Resources Control Procedure
5. Document Control Procedure
6. Record Control Procedure
7. Incoming Inspection Procedure, Process Inspection Procedure, Finished Product Inspection Procedure, and various product acceptance standards

Usage Instructions

1. How to Modify According to Company Practices

1. Release Stage Trimming: For pure assembly companies without process inspection points, the patrol inspection in section 4.3 can be deleted, retaining only the first piece confirmation and completion inspection. Service companies can convert "product release" to "service delivery pre-check," specifying the pre-delivery verification checklist (e.g., complete documentation, service content, customer confirmation). Modifications should ensure that the principle "planned arrangements have been completed" remains unchanged.
2. Authority Level Adaptation: In small companies, the quality inspection supervisor can handle all exceptional release approvals. In large companies, the approval process can be more detailed—general exceptional releases are approved by the inspection supervisor, concessions involving customers are approved by the sales/technical vice president, and those involving regulatory safety are approved by the general manager. The authority table should be included in this procedure or the job description.
3. Inspection Criteria Interface: This procedure only specifies "how to release." Specific judgment criteria are detailed in the inspection procedures/acceptance standards. Replace the inspection procedure names in the text with the actual document names used by the company to avoid discrepancies.
4. Record Number Adjustment: Modify the record codes QR-21-XX according to the company's numbering rules and update the "Record List" accordingly.

2. Audit Focus Points (Mandatory for External Audits)

1. Release Evidence Chain: Auditors will randomly select several batches of finished products to trace back inspection records, release forms, warehousing forms, and delivery records, checking for completeness, proper signatures, and logical time sequences. Ensure that each batch has a complete and closed-loop record.
2. Control of Exceptional Releases: Focus on whether exceptional releases have application forms, risk assessments, approvals, identification, and tracking. A common nonconformity is "no follow-up on emergency release results."
3. Customer Agreement for Concessions: When involving customer requirements, auditors will verify written customer consent evidence. Oral agreements or lack of records will result in nonconformities.
4. Interface Between Release and Nonconformities: Auditors will check whether nonconformities identified in the release process are handled according to clause 8.7, and whether release records and nonconformity records are consistent.
5. Personnel Authorization: Auditors will verify the authorization basis for release signatures (authorization documents/job responsibilities). Unauthorized signatures are considered serious issues.

3. Common Errors

1. Confusing "Inspection Conforming" with "Release": Conducting inspections without formal release procedures, or having a disconnect between release forms and inspection records, can break the traceability chain. Release is a combination of "inspection conclusion + authorized signature," both of which are essential.
2. Abuse of Exceptional Releases: Treating emergency releases as the norm, with long-term "release first, inspect later," and even emergency-releasing key characteristics. Limit the scope and frequency of emergency releases, and prohibit them for key/safety characteristics.
3. Using Concessions to Replace Nonconformity Handling: Using concessions to cover up recurring nonconformities without analyzing the causes or taking corrective actions, leading to repeated issues. Concessions are temporary acceptances and must be accompanied by root cause analysis and improvement.
4. Incomplete Records: Missing batch numbers, release criteria, or signatures in release records can make it impossible to trace issues. Ensure that record completeness is part of the inspector's performance evaluation.
5. Warehouse Not Recognizing Release Procedures: Warehouse operations based on "receive goods upon arrival" without verifying release forms can lead to mixing pending and conforming items. Clearly define warehouse procedures to ensure that non-released products are not warehoused or shipped.

Inspection must be conforming before release, exceptions are controlled and fully traceable

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.