ISO9001 System Document Package (17) | Production Process Control Procedure (8.5.1)

Document Description

This procedure corresponds to clause 8.5.1 "Control of production and service provision" of the ISO 9001:2015 standard. It is a core procedure in the product realization process (COP) and a critical link in transitioning the quality management system (QMS) from "documents" to "physical products." Its purpose is to ensure that production activities are carried out under controlled conditions, including the implementation of production plans, personnel capabilities, equipment status, material availability, process documents, environmental conditions, and monitoring and measurement resources. This ensures the stable production of products that meet customer requirements and legal regulations. This procedure applies to various manufacturing enterprises, including mechanical processing, electronic assembly, food, chemical, injection molding, and hardware industries, as well as service enterprises with on-site operations (such as installation, construction, and packaging services). Small and medium-sized enterprises (SMEs) can simplify or merge the clauses based on the number and complexity of their processes, but all six elements of "controlled conditions" (personnel, equipment, materials, methods, environment, and measurement) must be covered. This procedure is used in conjunction with the "Product Realization Planning Procedure," "Identification and Traceability Control Procedure," "Nonconforming Product Control Procedure," and "Monitoring and Measurement Resources Control Procedure" to form a complete closed loop for production process control.

1. Purpose

To standardize the control activities in the production and service provision process, ensuring that products are produced under controlled conditions, achieving the following objectives:

1. Production activities are carried out according to approved plans and process documents, preventing random or undocumented production.
2. Production preparation (personnel, equipment, materials, tooling, process documents, environment, and inspection resources) is fully and confirmed, eliminating "production with issues."
3. Key processes and special processes are effectively controlled and confirmed, ensuring process parameters are stable and under control.
4. Abnormalities in the production process (equipment failure, material anomalies, quality fluctuations, safety incidents) are promptly identified, addressed, and escalated.
5. Product identification and inspection status identification, as well as traceability requirements, are implemented on the production floor.
6. Production records are true, complete, and traceable, providing a basis for product release and continuous improvement.

2. Scope of Application

This procedure applies to the entire production control process from the issuance of production tasks to product warehousing (or delivery to customers), including but not limited to:

1. All production processes such as machining, assembly, debugging, and packaging of in-house components.
2. Re-processing and verification of outsourced processes after they return to the factory (outsourced processes themselves are managed according to the "Purchasing and External Provision Control Procedure").
3. Different types of production activities such as trial production, mass production, rework, and repair.
4. Equipment operation, tooling and fixture use, material requisition, and work-in-progress (WIP) transfer and temporary storage in the production area.
5. Confirmation and control of special processes (such as welding, heat treatment, electroplating, injection molding, painting, bonding, and curing).
6. Final protection and pending inspection management of finished products before warehousing.

The following scenarios are not applicable to this procedure: the entire outsourced production process managed by the supplier (according to the purchasing procedure); sample production during the design and development phase (managed according to the "Design and Development Control Procedure," but can refer to this procedure).

3. Responsibilities

4. Work Procedures

4.1 Issuance of Production Tasks and Plan Control

1. The production planner compiles the "Production Plan/Weekly Schedule" based on sales orders, inventory status, and production capacity. After review by the production department manager and approval by the general manager or the responsible leader, the plan is issued.
2. Before the plan is issued, a capacity and material availability check must be conducted: the load on key equipment should not exceed 110%, and the delivery dates of key materials should meet the start date. If not, the plan should be adjusted or procurement follow-up should be requested.
3. The workshop director receives the plan and breaks down the tasks to teams/machines, filling out the "Production Work Order/Dispatch Order" with details such as product name, specifications, quantity, batch number, planned start and completion times, and process document numbers.
4. Insert orders, change orders, and urgent orders must go through a review process (refer to the "Customer-Related Processes Control Procedure" and "Change Management Procedure"). Unauthorized changes to the production sequence or overproduction are strictly prohibited.

4.2 Production Preparation Status Check (Personnel, Equipment, Materials, Methods, Environment, Measurement)

Before each batch of products is produced, the team leader organizes a production preparation check based on the "six elements," filling out the "Production Preparation Check Form." Production can only commence after the check is passed:

1. Personnel: Operators must be trained and certified (special trades require corresponding qualifications) and familiar with the work instructions for their process. New employees or those changing positions must pass a job qualification assessment and be mentored by a senior operator.
2. Equipment and Tooling: Equipment inspections must be normal, and tooling, fixtures, molds, and cutting tools must be complete and in good condition. Measuring instruments must be within their valid calibration period, and key equipment status must be clearly marked.
3. Materials: Requisitioned materials must match the work order and be inspected and marked as qualified. Material identification and batch numbers must be clear, and the first-in, first-out (FIFO) principle must be strictly followed.
4. Methods (Process Documents): The current and valid versions of work instructions, process parameter tables, and inspection procedures must be distributed to workstations. No obsolete versions should be used.
5. Environment: Environmental conditions such as temperature, humidity, cleanliness, lighting, and ventilation must meet process requirements (monitoring records should be available if necessary). The 5S standard must be met, and there should be no safety hazards.
6. Measurement (Monitoring and Measurement): Measuring tools, gauges, and testing equipment used for process inspections must be complete and within their valid periods. Inspection standards (samples, limit samples) must be in place.

Batch production is not allowed before the first-piece is confirmed. If the production preparation check fails, the workshop director must organize corrective actions, and a re-inspection must pass before production can commence.

4.3 First-Piece Inspection

1. A first-piece inspection must be conducted at the start of each shift, each batch, and after each change in type, material, mold, or equipment repair.
2. After the operator completes the self-inspection, they fill out the "First-Piece Inspection Record" and submit it to the quality inspector for re-inspection. The inspector conducts a full inspection according to the inspection procedure, and only after a qualified determination and signature can batch production proceed.
3. If the first-piece is nonconforming, the operator must not adjust parameters and continue production without authorization. They should report to the team leader and technical personnel for cause analysis. After adjustments, a new first-piece must be produced and re-inspected to ensure it is conforming. Products produced during the period of first-piece nonconformity must be isolated for inspection.
4. The first-piece sample should be retained until the end of the batch production (or for the duration specified by the customer) as a basis for batch traceability.

4.4 Process Control and Process Discipline

1. Operators must strictly follow the steps and process parameters (temperature, pressure, speed, time, ratio, etc.) specified in the "Work Instruction" and must not make unauthorized changes.
2. Key processes (such as heat treatment, welding, injection molding parameters, assembly torque, etc.) should have process parameter monitoring points. Operators must record the "Process Parameter Monitoring Record" at the specified frequency and immediately stop the machine if parameters exceed limits.
3. The workshop implements a "three-inspection system": self-inspection by operators, mutual inspection between upstream and downstream processes, and specialized inspection by quality inspectors. Quality inspectors conduct process patrols according to the frequency and items specified in the "Process Inspection Work Instruction" and fill out the "Process Inspection Record."
4. Process discipline checks: team leaders conduct daily patrols, and the production department organizes weekly process discipline checks, focusing on document execution, parameter recording, identification and protection, and equipment inspections. The results of these checks are included in the team performance evaluation.
5. Operators for key processes and special processes should be relatively fixed, and any personnel changes must be retrained and re-evaluated.

4.5 Monitoring and Measurement of the Production Process

1. The quality department determines the process monitoring method and frequency based on product importance and process stability:
   • General processes: primarily first-piece inspection + patrols (every 2-4 hours).
   • Key processes: patrols are increased to every 1-2 hours, and statistical process control (SPC) using control charts (X-R charts) may be necessary.
   • Special processes: continuous monitoring and recording of confirmed parameters.
2. If the process experiences continuous nonconformities, a CPK below 1.33, or abnormal control charts, the quality department should issue a "Corrective Action Handling Form" and organize cause analysis and improvements according to the "Nonconforming and Corrective Action Procedure."
3. Process monitoring and measurement data (inspection records, control charts, parameter records) are regularly summarized and analyzed by the quality department, serving as input for the "Data Analysis and Evaluation Procedure."

4.6 Confirmation and Reconfirmation of Special Processes

For processes whose outputs cannot be verified by subsequent monitoring or measurement (such as welding, heat treatment, electroplating, injection molding, painting, bonding, and curing), process confirmation is mandatory:

1. Initial Confirmation: Organized by the technical department, this confirms the equipment capability, personnel qualifications, process parameters, materials, and environment, resulting in a "Special Process Confirmation Report" that specifies the process parameter ranges and monitoring requirements.
2. Confirmation Content: Equipment qualification records, personnel qualification certificates, process parameter test data (process evaluation/first-piece qualification if necessary), and sample inspection reports.
3. Reconfirmation Conditions: Reconfirmation is required after major equipment repairs or relocation, process parameter changes, material changes, large-scale personnel changes, production resumption after a shutdown, or customer or audit requests.
4. Records of process parameters for special processes must be continuously and completely preserved, with a retention period not less than the product lifecycle or the duration required by regulations.

4.7 Product Identification, Protection, and Traceability

1. WIP, semi-finished products, and finished products in the production area must be identified according to regulations (refer to the "Identification and Traceability Control Procedure"). Identification content includes product name, specifications, batch number, quantity, production date, and inspection status.
2. Inspection status identification is divided into four categories: "conforming (green)," "nonconforming (red)," "pending inspection (yellow)," and "conditional acceptance (blue)." These are clearly distinguished on-site using labels, zones, and color codes.
3. Flow cards/work orders accompany the products through the process, recording the processing and inspection status of each process to ensure that any product can be traced back to the raw material batch, operator, equipment, and inspection records.
4. WIP should be protected during transfer and temporary storage (preventing damage, moisture, rust, and material mixing), and stacking height and methods should comply with regulations.

4.8 Handling of Production Abnormalities

1. When the following abnormalities occur on-site, the operator or team leader must immediately stop the machine/line, hang a red "abnormal" sign, and isolate the relevant products. They should also report to the workshop director and the quality department: equipment failure, batch material nonconformity, process parameter loss of control, batch quality issues (three or more consecutive nonconformities), safety incidents, and environmental abnormalities.
2. The workshop director organizes a rapid analysis of the cause using the "six elements" and determines the handling plan:
   • Equipment failure: notify the equipment department for repair, and conduct equipment inspections and first-piece verification after repair.
   • Material anomalies: isolate the material and notify the quality department for re-inspection. If necessary, return the material or accept it conditionally.
   • Process anomalies: notify the technical department to adjust or restore the process, and assess the affected product range.
   • Quality issues: handle the isolated products according to the "Nonconforming Product Control Procedure."
3. After the abnormality is handled, the team leader fills out the "Production Abnormality Handling Record," noting the cause, handling measures, preventive measures, and verification results. Major abnormalities (affecting delivery or involving safety) must be reported to the production department manager and the general manager within one hour.
4. If the line is stopped for more than two hours due to an abnormality, the production planner should assess the impact on delivery and, if necessary, initiate communication with the customer (refer to the "Communication Management Procedure").

4.9 Shutdown and Resumption Management

1. If the shutdown (including holidays, equipment maintenance, planned production halts) exceeds 24 hours or if special processes exceed the specified time limit, a new production preparation status check must be conducted before resuming production. Special processes must be reconfirmed.
2. For production lines that have been shut down for more than 30 days, the frequency of first-piece inspections should be increased (three consecutive first-piece inspections must be conforming before resuming normal frequency).
3. Resumption check records should be archived together with the "Production Preparation Check Form."

4.10 Production Completion and Handover

1. After production is completed, the operator conducts a self-inspection and cleans the production area, filling out the "Daily Production Report" and submitting the flow card to the quality inspector for process/finished product inspection.
2. Qualified products are warehoused by the warehouse, managed according to the "Storage and Material Protection Work Instruction." Nonconforming products are handled according to the "Nonconforming Product Control Procedure."
3. The production planner summarizes daily production, plan achievement rates, and first-time pass rates, forming the "Daily Production/Weekly Report" as input for management reviews and data analysis.

4.11 Flowchart (Text Version)

Issuance of Production Plan → Production Preparation Check (Personnel, Equipment, Materials, Methods, Environment, Measurement) → First-Piece Inspection → Batch Production (Work Instruction + Self-Inspection and Mutual-Inspection) → Process Patrols/Parameter Monitoring (Increased frequency for key processes, continuous monitoring for special processes) → Process Inspection → Completion Self-Inspection and Cleanup → Finished Product Inspection → Qualified Warehousing/Nonconforming Disposal → Daily Production Statistics and Record Archiving

Abnormal Path: Discovery of abnormalities during production/patrols → Stop machine/isolate → Cause analysis (Personnel, Equipment, Materials, Methods, Environment, Measurement) → Handling and correction → First-Piece/Parameter Verification → Resume production; if handling is ineffective or affects delivery → Escalate and initiate corrective actions according to the "Nonconforming and Corrective Action Procedure."

5. Related Records

6. Related Documents

1. Quality Manual
2. Product Realization Planning Procedure (8.1)
3. Identification and Traceability Control Procedure (8.5.2)
4. Nonconforming Product Control Procedure (8.7)
5. Monitoring and Measurement Resources Control Procedure (7.1.5)
6. Infrastructure and Equipment Management Procedure (7.1.3)
7. Human Resources Management Procedure (7.1.2/7.2/7.3)
8. Nonconforming and Corrective Action Procedure (10.2)
9. Change Management Procedure (6.3/8.5.6)
10. Various Work Instructions (Process Cards, Equipment Operation Procedures, Inspection Procedures)

Usage Instructions

1. How to Modify According to Actual Enterprise Conditions

1. Organizational Structure Adaptation: For enterprises without an independent quality department, the responsibilities of the quality department can be assigned to the technical department or a designated full-time inspector. For enterprises without an equipment department, equipment inspection and maintenance responsibilities can be assigned to the workshop director or a designated equipment manager. The responsibility table should be adjusted according to the actual positions in the enterprise, but the roles of "production execution" and "quality inspection" must be performed by different personnel (small enterprises should at least ensure mutual inspection and spot checks).
2. Product Type Adaptation: For single-piece and small-batch enterprises (such as non-standard equipment, molds), the batch planning in section 4.1 can be simplified, and the first-piece qualification and process confirmation in section 4.3 can be strengthened, changing "first-piece inspection" to "first-piece qualification (FAI)." For process industries (chemical, food), section 4.4 on process parameter monitoring and section 4.6 on special process confirmation should be detailed, with the frequency of parameter recording adjusted according to the actual level of automation. Electronic assembly enterprises should add anti-static and error-proofing (Poka-Yoke) requirements.
3. Process Simplification: For micro-enterprises with fewer than five processes, sections 4.3, 4.4, and 4.5 can be merged into two requirements: "first-piece + patrols," without separate sections. Key process identification should be based on the process analysis results in the "Product Realization Planning Procedure," not necessarily increasing the number but ensuring sufficient justification.
4. Record Integration: The production preparation check form, first-piece inspection record, and process parameter record can be integrated into a single "Production Process Control Card" that accompanies the work order, reducing redundant entries.

2. Audit Focus Points (What Certification Auditors Typically Check)

1. On-Site Consistency: Auditors will randomly select a batch in production and verify whether the work order, work instruction version, parameter records, and inspection records are consistent. Common nonconformities include version mismatches and advance filling of records ("catch-up records").
2. First-Piece Execution: Check if first-piece records are completed before batch production and if they cover changes in type, mold, or equipment repair. Verify if the parameters of the first-piece and batch products are consistent.
3. Special Process Confirmation: Check if the confirmation report covers the four elements of equipment, personnel, parameters, and materials, and if reconfirmation conditions are triggered and executed. Ensure that special trades, such as welders, are certified.
4. Abnormality Closure: Randomly check abnormality records to ensure they follow the sequence of "cause analysis → handling → verification → prevention," avoiding only handling without corrective actions.
5. Traceability: Randomly select a finished product and trace back to the raw material batch, operator, and inspection records to ensure completeness.
6. Monitoring and Measurement Resources: Check if the measuring tools used on-site have valid calibration labels and if they match the records in the "Monitoring and Measurement Resources Control Procedure."

3. Common Errors

1. Process Documents and Actual Operations Are Separate: Work instructions are written in isolation by the technical department, and operators follow different practices. The procedure should specify a field confirmation step (evaluation after trial operation) and rely on process discipline checks to correct deviations.
2. Parameter Records Are Filled in Advance: Operators fill out records in advance at the end of their shift. The procedure should clearly specify the timing for record completion (real-time recording) and include spot checks by team leaders during patrols.
3. First-Piece Inspection Is a Formality: First-piece inspection is conducted simultaneously with batch production, losing its preventive significance. The procedure should clearly state that "production cannot commence without first-piece confirmation" and include this in performance evaluations.
4. Special Processes Not Identified: Special processes such as welding and heat treatment are managed as ordinary processes without confirmation records. The procedure should list the special processes of the enterprise and the conditions for reconfirmation.
5. Confused Identification: Conforming and pending inspection products are mixed, and there are no status identifiers. The procedure should specify on-site fixed zones and color management and include them in 5S checks.
6. Abnormalities Not Reported: Operators adjust parameters and continue production without reporting. The procedure should clearly specify the authority to "stop the line upon abnormality" and the escalation path, eliminating the fear of responsibility that prevents employees from reporting.

Production under controlled conditions, quality starts with process control

Knowledge Number: 2.3.1

Knowledge code: 2.3.1

Version: v20260809

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