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 conducted under controlled conditions, including the implementation of production plans, personnel capability, equipment status, material availability, process documents, environmental conditions, and monitoring and measurement resources, thereby consistently producing 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 according to the number and complexity of their processes, but all six elements of the "controlled conditions" (personnel, equipment, materials, methods, environment, and measurement) must be covered. This procedure is to be 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 of production and service provision processes, 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 preparations (personnel, equipment, materials, tooling, process documents, environment, and inspection resources) are fully confirmed, eliminating "production with issues."
3. Key processes and special processes are effectively controlled and confirmed, with process parameters remaining stable and under control.
4. Abnormalities in the production process (equipment failure, material anomalies, quality fluctuations, safety incidents, environmental abnormalities) are promptly identified, addressed, and escalated.
5. Identification, inspection status, and traceability requirements for products 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 the customer), including but not limited to:

1. Processing, 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. Production activities of different natures, such as trial production, mass production, rework, and repair.
4. Equipment operation, tooling and fixture use, material requisition, and in-process storage and transfer 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 inspection management of finished products before warehousing.

The following scenarios are not covered by this procedure: the entire outsourced manufacturing process implemented by the supplier (managed 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 for execution).

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 levels, and production capacity. After review by the production department manager and approval by the general manager or relevant 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 arrival of key materials should meet the start date. If not, the plan should be adjusted or the procurement department notified to expedite.
3. The workshop supervisor receives the plan and decomposes 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 undergo a review process (refer to the "Customer-Related Processes Control Procedure" and "Change Management Procedure"). Unauthorized changes to 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 must hold corresponding qualification certificates) and be 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 the workstations. Documents must be controlled, and the use of obsolete versions is prohibited.
5. Environment: Temperature, humidity, cleanliness, lighting, and ventilation must meet process requirements (monitoring records are required if necessary). The 5S standard must be met, and there should be no safety hazards.
6. Measurement (Monitoring and Measurement): Measuring tools, gauges, and test equipment used for process inspections must be complete and within their valid period. Inspection standards (samples, limit samples) must be in place.

Batch production is not allowed before the first article is confirmed. If the production preparation check fails, the workshop supervisor must organize corrective actions, and production can only resume after a re-inspection confirms compliance.

4.3 First Article Inspection

1. A first article 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 completing the self-inspection, the operator fills out the "First Article Inspection Record" and submits it to the quality department inspector for re-inspection. The inspector conducts a full inspection according to the inspection procedure, and production can proceed in bulk only after the inspector determines it is qualified and signs off.
3. If the first article is不合格, the operator must not adjust parameters and continue production without authorization. The team leader and technical personnel must analyze the cause, adjust the parameters, and re-produce the first article. The first article must be re-inspected and found合格before production can resume. Products produced during the period of first article不合格must be isolated for inspection.
4. The first article sample must 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 and report any parameter deviations.
3. The workshop implements a "three-inspection system": self-inspection by operators, mutual inspection between upstream and downstream processes, and specialized inspection by inspectors. Inspectors conduct process patrols at 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 inspections, and the production department organizes weekly process discipline checks, focusing on document execution, parameter recording, identification and protection, and equipment inspection. 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 followed by retraining and requalification.

4.5 Monitoring and Measurement of the Production Process

1. The quality department determines the process monitoring methods and frequencies based on product importance and process stability:
   • General processes: primarily first article inspection + patrols (every 2-4 hours).
   • Key processes: patrols are intensified to every 1-2 hours, and control charts (X-R charts) are used for statistical process control if 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 must issue a "Corrective Action Handling Form" and organize a root cause analysis and improvement 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 must be conducted:

1. Initial Confirmation: Organized by the technical department, this involves confirming the equipment capability, personnel qualifications, process parameters, materials, and environment. The "Special Process Confirmation Report" is formed, specifying the process parameter ranges and monitoring requirements.
2. Confirmation Content: Equipment qualification records, personnel qualification certificates, process parameter test data (process evaluation/first article inspection if necessary), and sample inspection reports.
3. Reconfirmation Conditions: Reconfirmation must be conducted after major equipment repairs or relocation, process parameter changes, material changes, significant personnel changes, production resumption after a shutdown, or when required by customers or audits.
4. The process parameter records for special processes must be continuously and completely saved, with a retention period not less than the product lifecycle or the duration required by regulations.

4.7 Product Identification, Protection, and Traceability

1. Work-in-progress, 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 is marked in four categories: "合格 (green)/不合格 (red)/待检 (yellow)/让步接收 (blue)." These categories are clearly distinguished on-site using labels, zones, and color codes.
3. Flow cards/work orders accompany the products through the processes, recording the processing and inspection status at each stage to ensure that any product can be traced back to the raw material batch, operator, equipment, and inspection records.
4. During the transfer and temporary storage of work-in-progress between processes, proper protection (against damage, moisture, rust, and material mixing) must be ensured, and the stacking height and method must 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, isolate the related products, and report to the workshop supervisor and quality department: equipment failure, material batch nonconformity, process parameter loss of control, batch quality issues (3 or more consecutive nonconformities), safety incidents, and environmental abnormalities.
2. The workshop supervisor organizes a quick analysis of the cause using the "六要素" (personnel, equipment, materials, methods, environment, and measurement) and determines the handling plan:
   • Equipment failure: notify the equipment department for repair, and conduct equipment inspection and first article verification after repair.
   • Material anomaly: isolate the material, notify the quality department for re-inspection, and return or accept with concessions if necessary.
   • Process anomaly: notify the technical department to adjust or restore the process, and assess the scope of affected products.
   • Quality issue: handle the isolated products according to the "Nonconforming Product Control Procedure."
3. After handling the abnormality, the team leader fills out the "Production Abnormality Handling Record," noting the cause, handling measures, preventive actions, and verification results. Major abnormalities (affecting delivery or involving safety) must be reported to the production department manager and the general manager within 1 hour.
4. If the abnormality causes a production stoppage exceeding 2 hours, the production planner must 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 a shutdown (including holidays, equipment maintenance, planned production stoppages) exceeds 24 hours or if a special process exceeds the specified time limit, a production preparation status check must be conducted again before resuming production. Special processes must be re-confirmed.
2. For production lines that have been shut down for more than 30 days, the frequency of first article inspections should be increased (three consecutive batches must be合格before resuming normal frequency).
3. Resumption check records are 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 product flow card to the inspector for in-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 calculates daily production, plan achievement rates, and first-time qualification rates, forming the "Daily/Weekly Production Report" as input for management review and data analysis.

4.11 Flowchart (Text Version)

Production plan issuance → Production preparation check (personnel, equipment, materials, methods, environment, measurement) → First article inspection → Batch production (work instruction + self-inspection and mutual inspection) → Process patrol/parameter monitoring (key processes intensified, special processes continuously monitored) → In-process inspection → Completion self-inspection and cleanup → Finished product inspection → Qualified warehousing/nonconforming product disposition → Daily production statistics and record archiving

Abnormal path: Abnormality detected during production/patrol → Stop machine/isolate → Cause analysis (personnel, equipment, materials, methods, environment, measurement) → Handling and correction → First article/parameter verification → Resume production; if handling is ineffective or affects delivery → Escalate and report → 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 Adapt to the Actual Situation of the Enterprise

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, the responsibilities for equipment inspection and maintenance can be assigned to the workshop supervisor or a designated equipment manager. The responsibility table can be adjusted according to the actual positions of 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 sampling inspection).
2. Product Type Adaptation: For single-piece and small-batch enterprises (such as non-standard equipment and molds), the emphasis on batch planning in section 4.1 can be reduced, and the focus on first article verification and process confirmation in section 4.3 can be increased, changing "first article inspection" to "first article verification (FAI)." For process industries (chemical, food), the focus should be on detailing process parameter monitoring in section 4.4 and special process confirmation in section 4.6, with the frequency of parameter recording adjusted according to the actual level of automation. For electronic assembly enterprises, requirements for electrostatic discharge (ESD) and poka-yoke should be added.
3. Process Simplification: For micro-enterprises with fewer than 5 processes, sections 4.3, 4.4, and 4.5 can be merged into two requirements: "first article + patrol," without separate sections. Key processes should be identified based on the process analysis results in the "Product Realization Planning Procedure," and the number of key processes should not be excessive but should be well-justified.
4. Record Integration: The production preparation check form, first article inspection record, and process parameter record can be integrated into a single "Production Process Control Card" that flows with 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 pre-filled parameter records ("catch-up records").
2. First Article Execution: Check whether first article records are completed before batch production and whether they cover changes in type, mold, or repair. Verify whether the parameters of the first article and the batch production are consistent.
3. Special Process Confirmation: Check whether the confirmation report covers the four elements of equipment, personnel, parameters, and materials, and whether reconfirmation conditions are triggered and executed. Ensure that special trades (such as welders) hold the necessary certificates.
4. Abnormality Closure: Randomly check abnormality records to ensure that the process of "cause analysis → handling → verification → prevention" is followed, avoiding situations where only handling is done 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 whether the measuring tools used on-site have valid calibration labels and whether they are consistent with 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 for process documents (evaluation after trial operation) and use process discipline checks to correct deviations.
2. Parameter Records Are Falsified: Operators fill out records all at once at the end of their shift. The procedure should clearly specify the timing for record filling (real-time recording) and include spot checks by team leaders during patrols.
3. First Article Inspection Is Perfunctory: First article inspection is conducted simultaneously with batch production, losing its preventive significance. The procedure should clearly state that "production cannot commence without first article confirmation" and include this in performance evaluations.
4. Special Processes Are Not Identified: Special processes such as welding and heat treatment are managed as ordinary processes, with no confirmation records. The procedure should list the special processes of the enterprise and the conditions that trigger reconfirmation.
5. Identification Confusion: Qualified products and products awaiting inspection are mixed, and there are no status identifiers. The procedure should specify the management of designated areas and color codes on-site and include these in 5S inspections.
6. Abnormalities Not Reported: Operators adjust parameters and continue production without reporting. The procedure should clearly specify the authorization and escalation path for "stop the line upon abnormality" to eliminate the fear of responsibility that prevents reporting.

Production under controlled conditions, quality starts with process control

Knowledge code: 2.3.1

Version: v20260809

Author: Quality Think Tank

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