Manufacturing Process Control Toolkit
Process control procedure, batch records (DHR), in-process inspection checksheets, SPC control chart templates, equipment qualification and calibration, and environment monitoring — complete manufacturing controls documentation.
What You Get
Manufacturing Process Control Procedure (21 CFR 820.70 + ISO 13485 Section 7.5)
Complete manufacturing process control procedure aligned with FDA QMSR 21 CFR 820.70 and ISO 13485 Section 7.5. Covers process parameter identification and control, production environment monitoring, equipment maintenance requirements, personnel qualifications, contamination control, and the production documentation requirements that FDA inspectors review during manufacturing site inspections.
Production Batch Record Template (Device History Record)
Comprehensive batch/lot record template that serves as the Device History Record (DHR) per FDA 21 CFR 820.184. Covers product identification, date of manufacture, quantity manufactured and released, acceptance records, labels and labeling, and the device identifiers required for UDI compliance. Pre-formatted with in-process inspection checkpoints and final release sign-off sections.
In-Process Inspection Procedure and Checksheet Template
In-process quality inspection procedure and checksheet for manufacturing operations. Covers critical control point identification, inspection frequency determination, measurement method specification, acceptance criteria, nonconforming product disposition protocol, and the statistical sampling plan options (AQL-based) for in-process inspection. Includes guidance on setting appropriate inspection frequency based on process risk.
Statistical Process Control (SPC) Implementation Guide and Control Chart Templates
SPC implementation guide with control chart templates for medical device manufacturing. Covers control chart selection (X-bar R, X-bar S, p-chart, c-chart, u-chart), subgroup size determination, control limit calculation, special cause detection rules (Nelson rules), and the process capability analysis that distinguishes capable from incapable processes. Includes Excel-based control chart templates.
Equipment Qualification and Calibration Control Procedure
Complete equipment qualification and calibration procedure aligned with ISO 13485 Section 7.6 and FDA 21 CFR 820.72. Covers equipment identification and classification, IQ/OQ/PQ requirements, calibration interval setting, out-of-calibration response procedure, equipment failure impact assessment, and the calibration records required for ISO 13485 audit evidence.
Production Environment Monitoring and Control Procedure
Environment monitoring and control procedure for controlled manufacturing areas. Covers environment classification requirements, monitoring parameter selection, alert and action limit establishment, excursion investigation procedure, personnel hygiene and gowning requirements, and the environmental monitoring data trending that feeds into management review and CAPA processes.
FAQ
What is a Device History Record (DHR)?
A DHR is the collection of records containing the production history of a finished device. FDA 21 CFR 820.184 requires manufacturers to establish and maintain DHR procedures and records. The DHR must include manufacture date, quantity, quantity released, acceptance records, labels, and device identification.
Is SPC required for medical device manufacturing?
Not explicitly required, but ISO 13485 Section 8.4 requires analysis of process performance data, and FDA expects statistical methods to be used when appropriate. SPC is widely used and expected evidence of a controlled manufacturing process during audits.
What format are the documents?
Word and Excel templates. SPC control charts are Excel-based with pre-built formulas.
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For informational purposes only. Not legal or regulatory advice. Legal