Written by Takayama — Paddy & Water Inc. / Supply Chain

Quality Management: A Complete Guide to Quality Planning, Inspection Execution, Results Recording, Quality Notifications, SPC, and SPRO Configuration

June 2026

Chapter 1: Overview of SAP QM and Integration with Other Modules

The Role of QM (Quality Management)

SAP QM (Quality Management) is a module that “plans, executes, records, and analyzes the quality of products, materials, and processes across the entire supply chain.” Its main functional areas include compliance with international quality standards such as ISO 9001, FDA 21 CFR Part 11, and GMP, management of inspection lots, supplier quality evaluation, and in-process quality control (SPC: Statistical Process Control).

QM establishes quality gates at multiple points in the business flow. QM functions at each stage of “incoming inspection (procured goods) → in-process inspection (during manufacturing) → final inspection (before shipment) → customer complaint handling.”

Key Business Scenarios Involving QM

・Incoming inspection of procured goods (QM in Procurement): an inspection lot is automatically created when goods arrive from a supplier ・In-process inspection during manufacturing (QM in Production): in-process quality checks linked to the production order ・Final inspection before shipment (QM in Sales): product inspection before shipment to the customer ・Quality Notification: management of complaints and corrective actions when defects occur ・SPC (Statistical Process Control): real-time monitoring of process capability using control charts

Interfaces with Other Modules

• Integration with MM (Materials Management): for items with QM configured, an inspection lot is automatically created upon goods receipt via MIGO (GR: movement type 101). The stock can only be used after the inspection has passed.

• Integration with PP (Production Planning): an in-process inspection lot is automatically created when a production order is released or at goods issue (inspection type 03). Interim inspections can be performed after each operation in the process.

• Integration with SD (Sales and Distribution): a final inspection lot is automatically created at the time of shipment to the customer (inspection type 10). A Certificate of Analysis (CoA) can be automatically generated and sent to the customer.

• Integration with PM (Plant Maintenance): calibration management of equipment (periodic calibration of inspection devices) is handled in QM (inspection type 14). A warning is displayed if an inspection is performed using a device whose calibration has expired.

Basic QM Concepts: Inspection Lots and Usage Decisions

The inspection lot is the core object of QM. One inspection lot is created for a “specific item × specific quantity × specific trigger (goods receipt, production order, shipment, etc.),” and the three steps of “assigning an inspection plan → recording results → usage decision” are carried out against that lot.

• Inspection lot number: an automatically assigned 10-digit number. It can be viewed in a list in QA33 (Inspection Lot Display).

• Usage Decision: a decision, based on the inspection results, that finalizes the lot as “Accept,” “Restricted Use,” or “Reject.” After the usage decision, the stock is posted (e.g., moved from usable stock to defective stock).

• Inspection lot status: transitions in the order CRTD (Created) → INSP (In Inspection) → UD (Usage Decision Made) → COMP (Completed).

Automatic Journal Entry Generation, Stock Movement Types, and Workflow

The Usage Decision in QM not only changes the stock status; depending on the outcome of the decision (scrapping, use under concession, etc.), it also automatically triggers the corresponding MM stock movement type and generates an FI journal entry. Quality Notifications (QN) integrate with workflow to automatically manage the tasks of the responsible persons from the occurrence of a defect through to the completion of corrective action.

Usage Decision Outcome	Movement Type (Stock Movement)	Automatic FI Journal Entry Generation
Accepted	321: Inspection stock → Unrestricted-use stock	No FI journal entry (movement within the same valuation class)
Rejected → Scrapped	344: Inspection stock → Scrap	Scrapping loss (GBB-VNG) ← Inventory (BSX); the valuation difference is posted automatically
Rejected → Returned to vendor	122: Inspection stock → Return to vendor	Decrease in inventory (BSX) ← Vendor returns account
Use under concession (conditional approval)	553: Special issue from inspection stock	Expense account ← Inventory (BSX); concession cost is posted
Accepted with restrictions	323: Partial acceptance (restricted-use stock → released)	No FI journal entry (stock status change only)

▌ Workflow: Quality Notifications, CAPA, and Approval of Inspection Results

・Automatic quality notification (QM01) creation WF: when an out-of-control (OOC) condition occurs during in-process inspection, a quality notification is automatically created and a Fiori task notification is sent to the quality staff ・8D report / CAPA WF: assignment of responsible persons, deadline setting, and completion confirmation for each step (D1–D8) of a quality notification are automatically managed by the quality notification WF ・Approval of corrective action effectiveness evaluation: a WF in which the quality manager approves the effectiveness check performed a set period after CAPA completion ・Inspection lot rejection → purchasing staff notification WF: when incoming inspection fails in QM in Procurement, the purchasing staff and the vendor contact are automatically notified to expedite return/replacement ・GxP compliance: usage decisions with electronic signature and the audit trail of inspection records (21 CFR Part 11) can be stored as the WF’s approval record

Chapter 2: QM Master Data

Material Master: QM View

Screen Example: MM01/MM02 — Setting up the QM View in the Material Master

• In MM02 (Change Material Master), select the QM view (the “Quality Management” tab). Settings are required at the plant/purchasing organization level.

• QM Procurement Active checkbox: when enabled, an inspection lot is automatically created when this item is received. When disabled, the item is posted directly to usable stock without inspection.

• Inspection Setup: activates the inspection types linked to the item (01: GR inspection, 03: production inspection, 10: shipping inspection, etc.).

• Whether a QIR (Quality Info Record) is required: sets whether a QIR is required for each vendor/item combination. It is possible to block procurement from vendors without a QIR.

• Certificate Type: sets the type of quality certificate required from the vendor upon receipt. It is also possible to block receipt if no certificate is provided.

Inspection Plan

The Inspection Plan is the central QM master record that defines “what, how, and how much to inspect.” It has a structure similar to a production routing (CA01), and is defined in a hierarchy of “operations (inspection steps) → characteristics (inspection items).”

Screen Example: QP01/QP02/QP03 — Creating, Changing, and Displaying Inspection Plans

• Launch QP01 (Create Inspection Plan). Enter the “material number, plant, group key (inspection plan number), and validity start date” and press Enter.

• Header data: set the name of the inspection plan, the Sampling Procedure, and the Dynamic Modification Rule.

• Operations (inspection steps): for example, enter “Operation 10: visual inspection, Operation 20: dimensional inspection, Operation 30: functional inspection.” For each operation, set the “operation text, work center (cost center of the inspection department), and inspection equipment category.”

• Characteristics (Inspection Characteristics): add inspection characteristics (inspection items) to each operation. Example: “Characteristic 1: outer diameter (quantitative; spec: φ10.00±0.05mm), Characteristic 2: surface roughness (quantitative; spec: Ra≤1.6μm), Characteristic 3: appearance (qualitative; pass/fail).”

• For quantitative characteristics: enter the “Upper Specification Limit (USL), Lower Specification Limit (LSL), target value, and unit.”

• For qualitative characteristics: set the “selected set (list of pass/fail codes: PA = Accepted, RE = Rejected, etc.).”

Sampling Procedure

Screen Example: QDV1/QDV2 — Creating and Changing Sampling Procedures

• QDV1 (Create Sampling Procedure): defines the sample size according to lot size. Choose from “fixed sample size (e.g., 5 units/lot), percentage (e.g., 10% of lot quantity), or AQL (Acceptable Quality Level) compliance (ISO 2859-1 compliant).”

• For AQL sampling: set the “AQL level (e.g., AQL 0.65, AQL 1.0, etc.) and inspection level (General Level II, etc.).” The sample size corresponding to the lot size is automatically calculated from the ISO table.

• Dynamic Modification Rule (QDB1): defines a rule that automatically changes the sampling level based on past inspection results — from “normal inspection → reduced inspection (when acceptances continue) → tightened inspection (when defects increase).”

Quality Info Record (QIR)

Screen Example: QI01/QI02/QI03 — Creating, Changing, and Displaying the QIR

• QI01 (Create Quality Info Record): creates a QIR (Quality Info Record) for each vendor/item combination. The QIR sets the “Vendor Approved flag, validity period of QI approval, reference to the inspection plan, and block reason.”

• Purchasing block when there is no QIR: if “QIR required” is set in the material master, a warning or block occurs when creating a purchase order or receiving goods from a vendor with no QIR.

• Managing the QIR approval validity period: setting an “approval expiration date” makes it possible to enforce periodic vendor audits and re-approval.

Chapter 3: Inspection Types and Inspection Lots

List of Main Inspection Types

The Inspection Type is a key that controls “on which business trigger a QM inspection lot is automatically created.” Each inspection type is activated/deactivated in the QM view of the material master.

• Inspection type 01 (GR inspection: receipt via purchase order): when goods are received via a PO in MIGO (movement type 101), an inspection lot is automatically created. This is the most commonly used incoming inspection type.

• Inspection type 03 (in-process inspection during production): an inspection lot is created against a PP production order at release or at confirmation (CO11N). Used for in-process quality control.

• Inspection type 04 (receipt without a purchase order): creates an inspection lot upon receipt via movement type 501 (goods receipt without a PO).

• Inspection type 05 (GI inspection: goods issue to a production order): creates an inspection lot at the time raw materials are issued to a production order (movement type 261).

• Inspection type 08 (stock re-inspection): periodic re-inspection of existing stock. Used in combination with best-before date (BBD) management.

• Inspection type 09 (receipt of in-house manufactured goods): creates an inspection lot for the finished product upon receipt from a production order (MIGO: movement type 101, with reference to the production order).

• Inspection type 10 (shipping inspection): creates the final inspection lot at the time of SD shipment (VL01N). The final quality check before shipment to the customer.

• Inspection type 15 (audit inspection): manually creates inspection lots for periodic internal/external quality audits.

• Inspection type 89 (manual creation): created manually by the responsible person at any time, rather than automatically by the system.

Displaying Inspection Lots

Screen Example: QA33 — Displaying and Listing Inspection Lots

• Launch QA33 (Display Inspection Lots). Filter by “plant, material, vendor, inspection type, date range, and lot status,” then execute with F8.

• Results list: lot number, material, quantity, status, and usage decision result are displayed in a list. Click the lot number to check details in QA03 (Display Inspection Lot).

• Checking for lots pending usage decision (UD Pending): selecting “INSP (In Inspection)” in the status filter extracts lots for which result recording or the usage decision has not yet been completed.

Screen Example: QA03 — Displaying Inspection Lot Details

• QA03: enter the lot number to check the details of the inspection lot. The “lot quantity, sample quantity, assigned inspection plan, list of operations, list of characteristics, and current status” are displayed.

• “Result Recording” button: navigates directly to the QE51N (Result Recording) screen. “Usage Decision” button: navigates directly to the QA11 (Usage Decision) screen.

Chapter 4: Recording Inspection Results

Result Recording Operations

Screen Example: QE51N — Recording Results for Multiple Characteristics (Recommended)

• Launch QE51N (Result Recording: Worklist). Specify the “plant, work center, and execution date” and execute with F8. A list of the inspection lots, operations, and characteristics to be inspected at that point is displayed.

• Select each characteristic line and enter the result: for quantitative characteristics enter the “measured value (a single value or multiple measured values),” and for qualitative characteristics enter the “pass/fail code (PA: Accept / RE: Reject, etc.).”

• Entering multiple measured values: select the characteristic line and press the “Single Results” button to enter “measured value 1, measured value 2, …, measured value n” for the number of samples. The mean, standard deviation, and Cpk are calculated automatically.

• When Out of Spec: if a measured value falls outside the USL/LSL, it is displayed “in red (as an overrun).” Recording is still possible, and this is reflected as a “Reject” result at the usage decision (QA11).

Screen Example: QE01 — Recording Results for a Single Operation

• QE01 (Result Recording: specifying an inspection lot + operation): records results by directly specifying the inspection lot number and operation number. Used to directly access a specific lot rather than using the worklist format of QE51N.

Screen Example: QE71 — Automatically Aggregating Lot Results from Sample Results

• QE71 (Lot Evaluation): automatically calculates the overall “Lot Acceptance/Rejection” decision from the measurement results of multiple samples, based on AQL rules. The result is reflected in QA11 (Usage Decision).

Calibration Management of Inspection Equipment

To ensure the reliability of inspection results, QM manages the periodic calibration of the measuring equipment used (calipers, micrometers, pressure gauges, etc.).

Screen Example: QM13 — Calibration Management of Inspection Equipment

• QM13 (Display Measuring Equipment Calibration): manages the “registration number, calibration date, next scheduled calibration date, calibration result, and person in charge” for measuring equipment.

• Integration with PM (Plant Maintenance): a configuration is possible in which measuring equipment is registered as a PM equipment master, and calibration work orders are automatically created via a periodic maintenance plan (IP42).

• Warning when using expired equipment: if “required calibrated equipment” is set on a characteristic in QP01, a warning is displayed when equipment whose calibration has expired is used during result recording in QE51N.

Chapter 5: Usage Decision and Stock Posting

Usage Decision

Screen Example: QA11 — Usage Decision for an Inspection Lot

• Launch QA11 (Usage Decision). Enter the inspection lot number (or select it from the QA33 list) and press Enter.

• Select a Usage Decision (UD) code. Typically, company-defined codes such as “A: Accept, R: Reject” are used. UD codes are defined in OQN1 in SPRO.

• “Follow-Up Actions” section: sets the follow-up processing linked to the UD code. Example: if accepted → posting to usable stock; if rejected → blocked stock or return processing.

• Usage decision with partial quantities: when part of a lot is to be accepted and part rejected, quantity-split entry is performed on the usage decision screen.

Stock Posting After the Usage Decision

• In the case of Accept: movement type 321 is automatically executed to move the stock from Quality Inspection Stock to Unrestricted Use Stock.

• In the case of Reject: follow-up actions such as “return (returned to the vendor: movement type 122),” “scrapping (movement type 551),” or “posting to blocked stock (movement type 344)” are automatically executed (depending on configuration).

• Conditional acceptance (Restricted Use): posted as Restricted-Use Stock, allowing use only for a specific, restricted purpose.

Screen Example: QA16/QA40 — Mass Processing of Usage Decisions

• QA16 (Automatic Setting of Usage Decisions): automatically sets an “Accept” decision in bulk for inspection lots in which all characteristics passed within specification. Used for mass processing of accepted lots that do not require manual confirmation.

• QA40 (Automatic Usage Decision for Overdue Lots): automatically processes inspection lots for which no usage decision has been made for an extended period, using a default decision.

Chapter 6: Quality Notification

The Concept and Types of Quality Notifications

A Quality Notification is a “tool for centrally managing quality problems (defects, complaints, corrective action requests), from occurrence through resolution.” It records the discovery of defective products, the receipt of customer complaints, and the reporting of internal quality issues in the system, and manages root-cause analysis, corrective action, and preventive action (CAPA: Corrective and Preventive Action).

• Notification type Q1 (customer complaint): accepts customer complaints from SD. Records the item, quantity, defect symptom, and damage on the customer side for the complaint. Can be linked to SD’s returns order (VR01).

• Notification type Q2 (internal defect notification): records internal defects found in manufacturing processes, warehouses, etc. Can be linked to PP production orders and materials.

• Notification type Q3 (vendor complaint): records vendor quality problems. Integration with MM’s vendor evaluation (ME61) affects the vendor’s evaluation score.

Screen Example: QM01/QM02/QM03 — Creating, Changing, and Displaying Quality Notifications

• Launch QM01 (Create Quality Notification). Select the notification type (Q1/Q2/Q3) and press Enter.

• Header information: enter the “defective item, plant, notification date, priority (urgent/high/normal), responsible department, and vendor/customer.”

• Defect Description: enter the “defect code (classification of the defect symptom), defect location, defective quantity, and scope of impact of the defect.” Defect codes are defined in OQN2 in SPRO.

• Cause Analysis: records the results of a cause-and-effect (fishbone) diagram or a why-why analysis as “cause text” and “cause code.”

• Corrective Actions: sets the “action content, responsible person, and due date” as a task. An email notification is automatically sent to the responsible person (depending on workflow configuration).

Screen Example: QM13 — Quality Notification Progress Report

• QM13 (Quality Notification List): displays a list of quality notifications filtered by notification type, status, item, and period.

• Status management: notification status is updated in the order OSNO (Not Started) → INPR (In Process) → COMP (Action Completed) → NOCO (Effectiveness Check Completed).

• Deadline management: tasks that have passed their action due date are highlighted in red, and reminders are automatically sent to the responsible person.

Integration with Vendor Evaluation

Screen Example: ME61/ME63 — Vendor Evaluation

• ME61 (Maintain Vendor Evaluation) / ME63 (Vendor Evaluation Execution): QM inspection results, the frequency of quality notifications (Q3), and the number of corrective action requests issued to vendors are aggregated as a score.

• The vendor evaluation score is classified into evaluation categories such as “quality, delivery, and price,” and can be compared and analyzed in ME65 (Vendor Evaluation Report).

Chapter 7: Statistical Process Control (SPC)

Overview of SPC (Statistical Process Control)

SPC (Statistical Process Control) is a quality management technique that “uses control charts to continuously monitor variation in the manufacturing process, detecting quality problems early before they cause major defects.” SAP QM provides SPC functionality as a standard feature and automatically generates control charts from inspection result data.

Setting Up and Viewing Control Charts

Screen Example: QGC1 — Setting Up SPC Control Charts

• QGC1 (Control Chart Settings): sets the control chart type (X-bar/R chart, X-bar/S chart, np chart, p chart, c chart, u chart), the calculation method for control limits (automatically calculated from historical data / manually set), the UCL/LCL (upper/lower control limits), and the subgroup size.

• “Warning Rules” settings: out-of-control detection rules based on Nelson Rules or Western Electric Rules can be configured. Example: a warning is issued as a trend if seven consecutive points fall on the same side of the control limits.

Screen Example: QGP1 — Displaying SPC Control Charts

• QGP1 (Display Control Chart): displays the control chart for a specified item, plant, characteristic, and period. The time-series plot of measured values, the UCL/LCL, and out-of-control points (shown in red) can be checked.

• When an out-of-control condition is detected: a configuration is possible in which the system automatically generates a Quality Notification (QM01). An alert is sent to the responsible person, allowing corrective action to begin immediately.

Managing the Process Capability Index (Cpk)

QM automatically calculates the “process capability index (Cp / Cpk)” as part of the statistical processing of inspection results. Cp (process capability) = (USL – LSL) / (6σ); Cpk (process capability index) = min[(USL – μ)/3σ, (μ – LSL)/3σ].

• Cpk ≥ 1.33 (4σ or higher): a common acceptance criterion for general mass-produced products.

• Cpk ≥ 1.67 (5σ or higher): the level of requirement in the automotive and medical device industries.

• After entering multiple measured values in QE51N: the “Statistics” button on the characteristic screen shows the automatically calculated Cp, Cpk, mean, standard deviation, and a histogram of the measured value distribution.

Chapter 8: Certificate of Analysis

Automatic Generation and Distribution of the CoA

The Certificate of Analysis (CoA) is a feature that “automatically generates a quality certificate containing inspection result data at the time a product is shipped from a vendor or from your own company.” It is mandatory as a regulatory or customer requirement in industries such as medical devices, food, and chemicals.

Screen Example: QC01/QC12 — Setting Up CoA Templates

• QC01 (Create Certificate Type): defines the CoA format (template). Sets the print layout for “the characteristics, measured values, specification limits, decision result, vendor information, lot number, etc.” to be displayed on the certificate.

• Linking to the material master: when a “certificate type” is set in the QM view of the material master, a CoA is automatically generated when that item is shipped.

Screen Example: QC21 — Printing the CoA

• QC21 (Print Certificate): prints or outputs a CoA as a PDF by specifying the inspection lot number. A workflow can also be configured to automatically attach and send the CoA in conjunction with SD invoicing (VF01).

Chapter 9: Detailed SPRO Configuration

Basic QM Settings

• QCC0 (Quality Management Configuration Menu): the root menu of the SPRO configuration for QM.

• SPRO → QM → Quality Planning → Inspection Planning → “Set Control Indicators”: sets the intended use of the inspection plan (usage flags for each module such as MM/PP/SD), the requirements for the usage decision, and the method of result recording.

Inspection Type Settings

• SPRO → QM → Quality Planning → Inspection Planning → Inspection Types → “Configure Inspection Types”: sets the “follow-up action, whether the usage decision is mandatory or optional, whether an automatic usage decision is possible, and the linkage to movement types” for each inspection type (01/03/04/05/08/09/10, etc.).

• “Conditions for Inspection Lot Creation”: precisely controls, through the combination of the GR movement type number and inspection type, “at what point in time a lot of which inspection type is created.”

Sampling and Dynamic Modification

• SPRO → QM → Quality Planning → Inspection Planning → Sampling → “Configure Sampling Schemes”: defines the AQL-compliant sampling calculation logic. The ISO sampling tables (ISO 2859-1) are built into the system and referenced automatically from the configured values.

• SPRO → QM → Quality Planning → Inspection Planning → Dynamic Modification → “Configure Dynamic Modification Rules”: defines the switching conditions (thresholds for the number of consecutive accepted or rejected lots) between normal inspection, reduced inspection, and tightened inspection.

Notification Settings

• SPRO → QM → Quality Notifications → “Configure Notification Types”: sets the “number range, status sequence, task settings, and partner functions (customer/vendor, etc.)” for each of Q1/Q2/Q3.

• OQN1 (Configure Usage Decision Codes): defines the UD codes for accept, reject, conditional acceptance, etc., and their follow-up actions (stock-posting movement type).

• OQN2 (Configure Defect Codes): defines the classification codes for defect symptoms used in quality notifications (appearance defect, dimensional defect, functional defect, packaging defect, etc.).

Settings for Integration Between QM and Other Modules

• SPRO → QM → QM in Logistics (Procurement) → “Activate QM Control”: a setting that incorporates QM into the MM procurement process. Sets whether QM is mandatory or optional for each “plant, material group, and procurement type.”

• SPRO → QM → QM in Logistics (Production) → “Activate QM Control (Production)”: settings for inspection lot creation at PP production order release, interim goods receipt, and final goods receipt.

Chapter 10: Implementation Case Studies

Case 1: Automotive Parts Manufacturer — Tightening Incoming Inspection and Supplier Quality Evaluation

Background and Challenges

At an automotive parts manufacturer, incoming inspection of parts procured from multiple suppliers depended on the experience and judgment of individual staff, and inspection criteria, sample quantities, and pass/fail decisions had become inconsistent between individuals. The customer (an automotive OEM) was strongly requiring compliance with IATF 16949 (an automotive quality management standard).

Standardizing Incoming Inspection with SAP QM

• Enabled the QM Procurement flag in the QM view of the material master for all purchased items, and configured the system so that an inspection lot is automatically created upon goods receipt via MIGO.

• Established inspection plans (QP01) for each item/vendor combination. Applied AQL sampling (ISO 2859-1, Level II, AQL 1.0), so that the sample size corresponding to the lot size is determined automatically.

• Created QIRs (Quality Info Records) for all approved vendors. Procurement from unapproved vendors was blocked by the system.

• Used quality notifications (Q3) for vendor complaints, automatically reflecting them in the quality evaluation metric of the vendor evaluation score via ME61. This served as the underlying data for SRM operations in the annual vendor ranking report (ME65).

Results

• Achieved complete standardization of incoming inspection criteria. Cleared the “objectivity and traceability of inspection records” requirements in the IATF 16949 external audit.

• Corrective action requests (SCAR: Supplier Corrective Action Request) to vendors that caused defects are now managed through QM notifications, making it possible to track the prevention of recurrence.

Case 2: Food Manufacturer — Introducing In-Process SPC and Early Detection of Quality Issues

Background and Challenges

At a beverage manufacturer’s filling line, periodic measurements of control characteristics such as fill volume, pH, and Brix (sugar content) were recorded in Excel, but detection of out-of-control conditions was delayed, resulting in cases where large quantities of defective product were produced. Early detection of anomalies and ensuring traceability to the production lot were challenges.

Introducing SAP QM SPC and In-Process Inspection

• Configured inspection type 03 (in-process production inspection) for the production order. An inspection lot is automatically created when the production order for the filling line is released.

• Defined characteristics for “fill volume, pH, Brix, appearance, and seal integrity” in the QP01 inspection plan. Set control limits (UCL/LCL) and specification limits (USL/LSL) for the quantitative characteristics.

• Configured an X-bar/R chart (subgroup size 5) control chart in QGC1. Put in place an environment in which the control chart can be viewed in real time via QGP1.

• Configured Nelson Rules warning rules (e.g., 8 consecutive points on the same side of the center line, 2 consecutive points beyond 3σ). When an out-of-control condition is detected, a QM notification (Q2) is automatically created and an alert is sent to the responsible person.

Results

• The average time to detect an out-of-control condition was reduced from approximately 4 hours (at the next periodic check) to approximately 15 minutes (automatic SPC warning).

• QM inspection records at the production lot level are now accumulated in SAP, greatly shortening traceability investigations in the event of a product recall.

Case 3: Medical Device Manufacturer — Automatic CoA Generation and FDA 21 CFR Part 11 Compliance

Background and Challenges

A medical device manufacturer and distributor is required to create and send a certificate of analysis (CoA) to the customer for every product shipment. Previously, inspection data was aggregated in Excel and the CoA was created in Word, which caused problems with work hours and transcription errors. Compliance with FDA 21 CFR Part 11 (electronic records and electronic signature regulations) was also required.

Automatic CoA Generation and Electronic Record Management with SAP QM

• Designed a CoA template in QC01. The “item, lot number, measured values of all characteristics, USL/LSL, pass/fail decision, inspection date, and inspector” for the inspection lot are automatically printed on the CoA.

• Built a workflow, linked to VF01 (Billing), in which a CoA PDF is automatically generated and sent to the customer by email at the same time as the shipping invoice.

• 21 CFR Part 11 compliance: enabled SAP QM’s electronic signature functionality (electronic approval at usage decision and quality notification closure). The change history (change log) of inspection records is automatically recorded by the system.

Results

• CoA creation effort has been reduced to zero. Automatic generation and automatic sending are now achieved at the moment of shipment.

• An environment is now in place that can immediately respond to requests to “present quality records” during an FDA inspection. The digitized QM records function as an audit trail that satisfies GxP requirements.

End.

What You Can Do with SAP QM — Key Quality Management Functions and Operations

SAP QM (Quality Management) is a module that performs quality inspections at each stage of procurement, manufacturing, and shipment, providing integrated management of early defect detection and corrective action. It offers advanced quality management functionality — including automatic inspection lot creation, stock status control through usage decisions, and quality notification workflows — that is also used to support GxP compliance.

▌ ① Automatic Creation of Inspection Lots and Execution of Inspections

・Receipt trigger (QM in Procurement): automatically creates an inspection lot at the same time as an MM goods receipt. Test items, specification values, and the sampling plan are automatically set from the inspection plan ・Production trigger (QM in Production): automatically creates an in-process inspection lot at production order release or upon completion of an interim process ・Shipping trigger (QM in Sales): automatically creates a final pre-shipment inspection lot when the shipping instruction is created ・QE51N result recording: enter the measured value and pass/fail result for each test item. Values outside specification are automatically flagged with a warning

▌ ② Usage Decision and Stock Status Control

・QA11 Usage Decision: after inspection is complete, determine accept/reject/conditional acceptance ・Accept → stock status changed to “unrestricted” (ready for shipment) ・Reject → shipment remains blocked while stock stays in “quality inspection” status. Selection of scrap, return, or use under concession ・Automatic journal entry linkage: an FI loss journal entry is automatically posted when rejected material is scrapped

▌ ③ Quality Notifications (QN) and Workflow

・QM01 quality notification creation: records customer complaints, process defects, and vendor defects in the system ・8D report: the system manages the 8-step corrective action process linked to the quality notification ・Workflow (WF): automatic task notification, escalation, and deadline management for the responsible person ・CAPA tracking: the system records the implementation status and effectiveness evaluation of Corrective Action and Preventive Action

▌ ④ SPC (Statistical Process Control)

・Control charts (Xbar-R, Xbar-s, p chart): plot process data in real time to monitor process stability ・Automatic calculation of the process capability index (Cp/Cpk): quantitatively evaluates process variation against specification ・Automatic alarm for control limit violations: anomaly detection based on Western Electric Rules/Nelson Rules ・GxP compliance: electronic recording, electronic signature, and audit trail for inspection records for the pharmaceutical and food industries (integrated with 21 CFR Part 11)