Sap Qm

SAP Quality Management (QM) Skill

1. Environment Intake Checklist

Before starting QM troubleshooting or configuration, collect:

• SAP Release: ECC 6.0 (SP number), S/4HANA 1909+, S/4HANA Cloud
• Deployment: On-premise (ECC/S/4 OP) | Private Cloud (RISE) | Public Cloud (SAP QMS)
• QM Activation: SPRO > SAP Customizing for Quality Management configured?
• Scope: 구매(MM) 수입검사 | 생산(PP) 공정검사 | 판매(SD) 납품검사
• Industry: 제조업(일반) | 화학 | 제약(GMP) | 식품(HACCP) | 자동차(IATF 16949)
• Quality Strategy: 100% 검사 | Sampling plan (AQL-based) | Zero-inspection (trusted supplier)
• Integration: MM-QM 구매검사 | PP-QM 공정검사 | SD-QM 납품검사 | QM-PM 통지서 연동

Skill will adapt all answers to user's specific SAP release, deployment, and industry context.

2. Quality Planning (QP01/QP02/QP03, QS21/QS31, QDV1)

2.1 Inspection Plan Structure (검사계획)

Transaction: QP01 (Create), QP02 (Change), QP03 (Display)

Logical hierarchy:

Inspection Plan Header (PLKO)
├─ Plan Number (PLNNR): 자동 또는 수동 부여
├─ Material (PLKO-MATNR) + Plant (PLKO-WERKS)
├─ Inspection Type (PLKO-LOART):
│  ├─ 01: Purchasing (구매 입고 검사)
│  ├─ 03: Production (공정 검사)
│  ├─ 04: Sales (판매 출고 검사)
│  └─ 08/09: Recurring/Source
├─ Valid from/to (PLKO-GDATU ~ PLKO-GDATU_END)
└─ Status: 1=Created, 2=Released, 3=Locked
    └─ Inspection Operations (PLPO) — 검사 단계별
        ├─ Operation number (OPNR): 10, 20, 30...
        ├─ MICs (Master Inspection Characteristics — PLMK)
        └─ Sampling Procedure (QDV1 reference)

Key Tables:

• PLKO: Plan header (Inspection plan name, type, dates)
• PLPO: Plan operations (Operation sequencing, MIC assignment)
• PLMK: Plan-MIC assignment (QPMK reference)
• QPMK: Master Inspection Characteristics (검사특성 마스터)

한국 현장 팁: IATF 16949 대비 각 Operation마다 검사기준(Specification) 명확히 입력 필수. LSL/Target/USL 3개 다 입력.

2.2 Master Inspection Characteristics (MIC) — QS21/QS31

QS21 Transaction (Create MIC):

• MIC Code (QPMK-MERKM): 산도, 경도, 수분율, Tensile strength 등
• Type (QPMK-MERTY): 1=Quantitative (수치), 2=Qualitative (합격/불합격)
• Unit of measure (QPMK-MEINS): mg/L, HV, %, ppm
• Valuation (QPMK-BWFL): A=Automatic, B=Manual, C=Reference sample

Specification Definition (QS31 — Material에 대한 MIC 기준값):

• LSL (Lower Spec Limit): QPSP-LSL
• Target (Nominal): QPSP-ZIELW
• USL (Upper Spec Limit): QPSP-USL
• Tolerance (±): QPSP-ABWG

예시 (제약 API 수분율):

MIC Code: MOISTURE
Type: Quantitative
Unit: %
Specification:
  LSL: 1.0%
  Target: 2.5%
  USL: 5.0%
Valuation: Automatic (측정값 vs LSL/USL 자동 비교)

2.3 Sampling Procedure Configuration (QDV1)

Purpose: Lot size에 따른 샘플 크기 결정 (ISO 2859-1 AQL 기반)

Three sampling schemes:

• Single: 1차 샘플링으로 최종 판정 (Accept/Reject)
• Double: 1차 inconclusive → 2차 샘플링
• Sequential: 합격 판정될 때까지 계속 샘플링

AQL Parameters:

• AQL (Acceptable Quality Level): 예) 1.0% = 최대 1% 불량 허용
• Sample size letter (A~M): ISO 2859-1 lookup table (QPSA 테이블)
• Acceptance number (Ac): "합격" 수량
• Rejection number (Re): "불합격" 수량

Configuration Path: SPRO > QM > Quality Planning > Sampling > Define Sampling Procedure

Key Tables:

• QPSA: Sampling header
• QPSX: Sampling level (Normal/Tightened/Reduced)

한국 자동차: 보통 AQL 2.5% or 4.0% (supplier 신뢰도에 따라 분화)

2.4 Dynamic Modification Rules (QDR1)

목적: 연속 검사 결과에 따라 샘플 크기 동적 조정

Transition Rules:

• Normal → Tightened: N개 불합격 로트 발견 시 (예: 5회)
• Tightened → Normal: M개 연속 합격 로트 (예: 5회)
• Normal → Reduced: K개 연속 합격 + 조건 만족 시 (예: 25회)
• Reduced → Normal: 불합격 또는 OOS 검출

설정 예:

Tightened entry: 불합격 횟수 = 5
Tightened exit: 합격 횟수 = 5
Reduced entry: 합격 횟수 = 25 AND 불합격률 < 0.5%
Reduced exit: 불합격 1회 (즉시)

생산 관점: Tightened 진입 시 생산 속도 저하 (샘플 size ↑) → 원인 파악 및 시정 urgency ↑

3. Quality Inspection — Inspection Lot & Results Recording

3.1 Inspection Lot Creation (QA01)

Inspection types (검사유형, QALS-LOART):

• 01: GR Inspection (구매 입고 검사) — MIGO 후 자동 또는 수동
• 03: In-process (생산 공정 검사) — 공정 단계별 타이밍
• 04: GI Inspection (판매 출고 검사) — MIGO GI 전
• 08: Recurring inspection (반복 검사) — 정기적 재검사
• 09: Source inspection (원산지 검사) — 공급사 공장에서

Automatic Creation Flow:

Material Master (MM02):
  QM Control Level (IQMC) = "01" 또는 "02"
    ↓
Purchasing Info Record (ME11) 또는 Quality Info Record (QI01):
  Inspection plan flag = "X"
    ↓
MIGO (GR posting):
  자동 → Inspection Lot 생성 (QALS)
    ↓
QA25 (Background job):
  Daily/Hourly run → 대량 검사로트 생성

Manual Creation (QA01 T-code):

QA01 Screen:
├─ Material Number (QALS-MATNR)
├─ Quantity (QALS-MENGE)
├─ UoM (QALS-MEINS)
├─ Supplier (QALS-LIFNR) — Type 01 구매의 경우
├─ Inspection Type: 01/03/04/08/09
├─ Inspection Plan: 자동 상속 (PLKO → QALS-PLNNR)
└─ Lot number (QALS-LOSNR): Auto/Manual

Key Table: QALS (Inspection Lot Header)

3.2 Sample Definition (QPR1/QPR2)

Sample Determination (샘플 결정):

1. Inspection Plan → Sampling Procedure (QDV1) lookup
2. Lot size입력 → Sample size 자동 계산 (ISO 2859-1)
3. Sample selection strategy:
   • Sequential: Units 1, 2, 3... n
   • Random: SAP random number generator
   • Every nth: e.g. 매 5번째 unit

Sample Recording (QPR1 Transaction):

QPR1:
├─ Select Inspection Lot (QALS)
├─ System proposes sample size & strategy
├─ Assign sample units (팔레트/박스 ID 또는 연번)
└─ Print sample labels (for inspection lab)

Key Tables: QASE (Sample header), QASV (Individual sample values)

3.3 Results Recording (QE01/QE51N)

QE01 Transaction (Classic GUI):

QE01:
├─ Select Inspection Lot (QALS)
├─ Record per Characteristic (MIC):
│  ├─ Quantitative: 수치 입력 (예: 98.5 mg/L)
│  │  → 자동 vs LSL/USL 비교 → Pass/Fail
│  └─ Qualitative: Accept/Reject 선택
├─ Record Defects (optional):
│  ├─ Defect code (QMFE-MFEHL, e.g. CRACK, BURN)
│  └─ Quantity affected
└─ Save (QASR 테이블에 기록)

QE51N (Fiori App — Mobile inspection input):

• 모바일 친화 UI
• QR code 스캔 → sample 빠른 접근
• 검사기기 API 직접 연동 (자동 수치 입력)
• Offline mode 지원

Result Evaluation (자동):

• Individual MIC result: Pass (수치가 LSL~USL 범위) / Fail (Out of spec)
• Lot-level judgment: 별도 UD (Usage Decision) transaction에서 수행

Key Tables:

• QASR (Result header — Lot별)
• QASV (Sample value — 개별 샘플 수치)
• QAVE (Evaluation — 최종 Pass/Fail 기록)

3.4 Statistical Process Control (SPC) — 관리도

SPC Configuration (Quality Control 메뉴):

SPRO > QM > Quality Control > Define Control Chart

Chart Types:

• X-bar & R chart: 연속 공정 (mean ± std dev tracking)
• p-chart: Proportion defective (불량률 추적)
• c-chart: Defect count (결함 개수)

Triggers:

• 관리한계(Control limit) 벗어남 → QM notification 자동 생성
• 추세(Trend): 8개 연속 point가 center line 한쪽 → 경고
• Rule violations → Root cause investigation 유도

생산 현장 활용: 공정능력(Cpk) 사전 평가 후 매 로트마다 모니터링 — 즉시 이상 감지

4. Usage Decision (QA11/QA12/QA13)

4.1 UD Creation & Codes

Transactions:

• QA11: Create Usage Decision
• QA12: Change
• QA13: Display

UD Codes (최종 판정):

• A: Accept (합격) — 재고로 입고 가능, 다음 공정/판매 진행
• R: Reject (불합격) — 재고 차단, 반품/폐기 예정
• B: Conditional (조건부) — 고객 승인 대기 또는 재작업
• S: Return to supplier (공급사 반송 — 수입검사 Type 01에서만)

UD Creation Flow:

QA11:
├─ Select Inspection Lot (QALS-LOSNR)
├─ System shows all MIC results (QASR 요약)
├─ Judge UD Code:
│  ├─ All MIC pass + No defects → "A" (Auto-recommend)
│  ├─ Any MIC fail OR Defects found → "R"
│  └─ Marginal case → "B" (with reason text)
├─ Optional: Partial acceptance (Accepted qty ≠ Lot qty)
└─ Save (QAVE 테이블)

Key Table: QAVE (Usage Decision record)

4.2 Post-UD Actions (Follow-up Processing)

Accept (A) → Stock Posting:

MIGO blocked GR → Auto-completed
↓
Inventory: Material received into active stock
↓
Next process (Production consume, Sales ship) can proceed

Reject (R) → Stock Management:

QALS → QAVE (UD=R)
↓
Blocked stock (QMSL, 품질보류 재고)
↓
Options:
├─ Scrap posting (MIGO Scrap)
├─ Return to supplier (Vendor credit memo)
└─ Rework (if internally caused failure)

Conditional (B) → Quality Hold:

QAVE (UD=B, reason= "고객확인대기")
↓
Stock in Quality Hold (QM block)
↓
Customer approval → Update UD to "A" → GR completes
   OR Denial → Change to "R" → Scrap

Quality Notification Trigger (자동):

If UD = R:
  → QM01 자동 생성 (Customizing 설정)
  → Defect history 기록
  → Supplier evaluation score 반영

4.3 Partial Lot Acceptance (부분 합격)

Scenario: 100개 로트 → 98개 OK, 2개 불량

QA11 Handling:

QA11:
├─ Select QALS (Qty=100)
├─ UD Code = "A" (Accept partial)
├─ Enter "Accepted qty" = 98
├─ Enter "Rejected qty" = 2
└─ Save
    ↓
MIGO posting: +98 to active stock, +2 to blocked stock
    ↓
결과: 총 100개 중 98개만 사용 가능 (GR 재무 기장도 98개 기준)

Key Field: QAVE-MNGEA (Accepted qty), QAVE-MNGEB (Rejected qty)

4.4 Automatic UD Processing (QA32)

Purpose: 검사 완료되었으나 UD 수동 미생성 로트 자동 판정

설정:

SPRO > QM > Quality Inspection > Inspection Lot > 
  Define Automatic Usage Decision
    ↓
Rule 설정:
├─ All samples passed AND no defects → Auto "A"
├─ Any sample failed OR Defects → Auto "R"
└─ Automatic update flag = X

QA32 실행:

QA32 Report:
├─ Selection: Lot status 04 (Results recorded, UD pending)
├─ Execute → Background job
└─ Result: UD records created for matching lots

생산 관점: 월마감 전 일괄 처리로 미결 검사로트 정리

5. Quality Notification (QM01/QM02/QM03)

5.1 Notification Structure & Types

Transactions:

• QM01: Create Notification
• QM02: Change
• QM03: Display

Notification Types (QMEL-QMART):

• Q1: Customer Complaint (고객 클레임)
• Q2: Internal QM (내부 품질 문제, 불합격 로트 등)
• Q3: Vendor (공급사 품질 불량)
• L1: General Complaint (총괄)

Typical Triggers:

• QA11 UD=R → Auto-create Q2
• Customer call → Manual create Q1
• Source inspection fail → Manual create Q3

5.2 8D Methodology → SAP Fields

8D 단계별 SAP 매핑:

5.3 Defect & Root Cause Entry (QMFE table)

QM01 → Defects Tab:

QMFE Entry:
├─ Defect code (MFEHL): SAP-정의된 코드 lookup
│  예) CRACK, DISCOLORATION, CHEMICAL_BURN, DIMENSION_OOS
├─ Defect description (free text): 추가 설명
├─ Quantity affected (FEHLM): 몇 개 유닛 영향
├─ Cause code (UAQZ):
│  ├─ O: Original (근본원인)
│  └─ I: Immediate (직접 원인)
└─ Link to related defects (if multi-cause)

예시 (제약 변색 클레임):

Defect: DISCOLORATION
Qty affected: 50 units (전체 케이스 중)
Immediate cause: Storage temperature exceeded 30°C
Root cause: Warehouse A/C malfunction
Related defect: Shelf-life reduction (expiration moved from Y+3 to Y+1)

5.4 Corrective Action Task Creation

QM01 → Activities Tab:

QMMA (Activity/Task) Creation:
├─ Activity type (APTY):
│  ├─ "Corrective" — CA task
│  ├─ "Diagnostic" — RCA investigation
│  └─ "Preventive" — Future prevention
├─ Description: "Replace warehouse A/C unit"
├─ Responsible person (AQUA): Maintenance manager
├─ Due date (FDZZ): 7 days urgency
├─ Budget code (if applicable): Cost center assignment
└─ Status (TSTA): 01=Created, 02=In progress, 03=Completed

Task Monitoring (QMMA table):

• Progress tracking (% complete)
• Evidence upload (documents, photos)
• Verification meeting schedule

5.5 Integration with PM (Production Maintenance)

Cross-module Flow:

QM Notification (Quality issue detected)
  ├─ Defect code = "Equipment malfunction"
  ├─ Task type = "Maintenance required"
  └─ Create PM Notification (Type PM, QMEL-QMART)
      ↓
PM01 Maintenance notification created
      ↓
PM order (IW32) generated
      ↓
Maintenance execution, cost tracking
      ↓
Feedback: Equipment repaired → QM closes Q2

한국 현장: 생산 일정(PP) ↔ 설비 정비(PM) ↔ 품질 이슈(QM) 동시 조정 필요

6. Quality Certificate (QC01/QC21)

6.1 Certificate Profile Configuration (QC01)

QC01 Transaction (Certificate profile 정의):

QC01:
├─ Certificate name/ID (예: "CoA_PHARMA_ENG_v2")
├─ Material assignment (특정 material에만 cert 발행)
├─ Certification rule:
│  ├─ Automatic: 모든 delivery마다 자동 생성
│  ├─ Manual: QC21에서 수동 생성
│  └─ On-demand: 고객 요청 시만
├─ Language variant (EN, DE, ZH, KO 등)
├─ Form/Template: SMARTFORM (ZQC_*) 또는 Adobe Forms
└─ Archive setting: E-signature required?

Key Fields:

• ZQCMO-VRSNO: Version tracking (변경 이력)
• ZQCMO-SPRACHE: Language code (EN, DE 등)
• ZQCMO-FMNAME: Form name (출력 양식)

6.2 Certificate of Analysis (CoA) Content & Generation

CoA 구성:

Header Section:
├─ Company: 법인명, 주소
├─ Material: 제품명, 규격 코드
├─ Lot/Batch: 로트번호, 유효기간
└─ MFG Date, Expiry Date

Test Results Table:
├─ Characteristic (MIC code)
├─ Specification (LSL-Target-USL)
├─ Test result (실제 측정값)
├─ Unit of measure
├─ Status (Pass/Fail ✓/✗)
└─ Test date, Lab ID

Footer:
├─ Authorized signature block
├─ QA Manager stamp
├─ Archive reference
└─ QM lot number (추적용)

Generation Methods:

1. Manual (QC21):

   QC21:
   ├─ Select QM Lot (QALS-LOSNR)
   ├─ System retrieves QASR results
   ├─ Generate PDF (SMARTFORM or Adobe)
   └─ Save to DMS or Email to customer
   

2. Automatic (Delivery):

   SD Delivery (Packing stage)
   ├─ Check certificate requirement (QC01 flag)
   ├─ Link to QM lot UD (if type 04 inspection)
   ├─ Auto-trigger QC21 if UD=A
   └─ Attach to output (NAST message)
   

Key Tables:

• ZQCMO: Certificate master
• ZQCDR: Certificate data records (실제 인증서 발급 기록)

6.3 Outbound Certificate at Delivery (배송 인증서)

Process Flow (SD → QC21):

Sales Order (SO) → Delivery (Picking/Packing)
    ↓
QM Lot (Type 04, GI Inspection) UD = "A" ?
    ↓ YES
Execute QC21 automatically (Customizing)
    ↓
Generate CoA PDF → Archive + Email to customer
    ↓
NAST (Message configuration) — Invoice와 함께 첨부
    ↓
Customer receives: Packing note + CoA + Invoice

NAST Configuration (Output 설정):

NAST T-code:
├─ Application: V3 (Sales & Shipping)
├─ Message type: RD (Delivery note) or INVOICE
├─ Form: ZQC_COA (Certificate form)
├─ Trigger: 10 = Post goods issue
├─ Medium: 1=Print, 2=Email, 5=Archive
└─ Output program: RLQC_QC21_OUTPUT (standard SAP report)

생산 관점: 납품 직전 자동화로 수동 CoA 생성 일 감소

7. QM-MM Integration (구매/수입검사)

7.1 Quality Info Record (QI01/QI02/QI03)

Purpose: 공급사별, Material별 품질 관리 정책 정의

QI01 Create:

QI01:
├─ Supplier (LIFNR)
├─ Material (MATNR)
├─ Inspection plan (PLNNR reference) — source inspection plan
├─ Quantity exemption (QE): 이 수량 이상만 검사 필수
├─ Inspection control code (QZGTP):
│  ├─ 01: Inspection mandatory
│  ├─ 02: 100% inspection (까다로운 supplier)
│  └─ 03: No inspection (trusted source)
├─ Certificate requirement (INFE): CoA 필수?
└─ Quality weighting (GEWBP): 공급사 평가 가중치

Key Table: EINE (Info Record vendor-specific)

예시 (신규 공급사 vs 우수 공급사):

Scenario 1: New supplier X
├─ Inspection plan: Standard (Type 01, AQL 2.5%)
├─ Certificate required: Yes
├─ Qty exemption: 0 (모든 로트)
├─ Control code: 01 (Mandatory)

Scenario 2: Preferred supplier Y (IATF 16949 certified)
├─ Inspection plan: Reduced (AQL 6.5%)
├─ Certificate required: No
├─ Qty exemption: 1000 (1000개 이상만 검사)
├─ Control code: 03 (No inspection)

7.2 Vendor Evaluation (공급사 평가 — ME61)

Scoring Model (공급사 점수):

• Quality score: (Accepted lots / Total lots) × 100 [%]
• Delivery score: On-time delivery %
• Price performance: Quoted price vs actual cost variance

SAP Calculation:

Quality score = Sum(QAVE UD="A") / Count(QAVE) × 100

Example:
├─ Total QM lots: 20
├─ Accepted (UD=A): 19
├─ Rejected (UD=R): 1
└─ Quality score = 19/20 × 100 = 95%

Impact on Sourcing:

Quality score tracking (ME61):
├─ > 98% → Preferred supplier, Reduced inspection
├─ 95-98% → Standard supplier, Normal inspection
├─ < 95% → At-risk supplier, Tightened inspection or hold PO

Table: EIVR (Evaluation record — 역사 추적)

한국 현장: 대기업 협력사 평가 (삼성 S-rating, 현대 Quality score) 연동

7.3 Blocked Stock Management (차단 재고)

Stock Categories (after QM inspection):

• Inspection stock (QMSPL): 검사 진행 중 (reserved)
• Quality hold: Conditional UD (B) 대기 중
• Blocked stock: Reject UD (R) → 폐기/반품 예정

Transaction MRB (Return/Credit):

MRB (Goods return):
├─ Select Inspection Lot (QALS)
├─ Create Return PO
├─ Vendor credit memo (MIRO posting)
└─ Inventory: Reject qty → return to supplier

Goods Movement:

GR (Type 01 inspection):
├─ Initial: MIGO goods receipt 직후 → Inspection stock
├─ After UD=R: MIGO "Return" → Supplier return
├─ After UD=A: Automatic transfer to active stock

8. QM-PP Integration (생산/공정검사)

8.1 In-Process Inspection (공정 중 검사)

Configuration (PP Production Order):

Production Order (Auftragsart):
├─ Operation (공정단계): 포장, 테스트, 최종검사
├─ QM hold point: "X" (검사 완료까지 다음공정 금지)
├─ Inspection plan (Type 03): 공정 검사 계획 연결
└─ Sample size: 로트 크기 기반 자동 계산

Flow:

Production order start
    ↓
Perform operation (manufacturing)
    ↓
QM Lot creation (Type 03) — automatic or manual
    ↓
Inspection: Sample → QE01 results recording
    ↓
UD creation (QA11) — All OK?
    ├─ Yes (A) → Release hold → Next operation proceeds
    └─ No (R) → Block → Rework or scrap decision

Impact: 공정 지연 risk (불합격 시 다음 공정 정지)

8.2 Goods Receipt from Production (생산입고 검사)

Scenario: In-process inspection 완료 후, 완제품을 내부 warehouse에 GR

Inspection Lot (Type 01 GR):

MIGO GR (Production order completion):
├─ Auto-create Inspection Lot (Type 01)
├─ Inspection Plan (Material, Plant)
├─ Sample size lookup (QDV1)
└─ Status: Inspection stock (차단 재고)
    ↓
    QE01 Results recording
    ↓
    QA11 UD creation
    ↓
    If UD=A: Goods transfer to active stock

Key Difference: In-process (Type 03) vs GR (Type 01) — 수량, 샘플 크기, 통지서 연동이 다름

8.3 Batch Determination with QM Results

Integration (Batch traceability):

Batch Master Data (CHVW):
├─ Batch characteristic (예: Tensile strength)
├─ Value assigned from QM lot result (QASR)
└─ Batch determination rule (BDCR) lookup

Example:

Customer order request: "High-strength material (Tensile > 500 MPa)"
    ↓
SAP batch determination:
├─ Query batch characteristics in CHVW
├─ Filter: Batches with Tensile > 500 MPa
├─ Link to QM lot (QALS) to verify test date freshness
└─ Auto-assign batch to sales order

생산 관점: 품질 등급화로 다양한 customer requirement 대응

9. ECC vs S/4HANA — Quality Management Differences

Key S/4HANA Simplifications (단순화):

1. Simplified Inspection Lot: 결과 직접 UD 판정 (중간 단계 축소)
2. Embedded Quality Dashboard: BI 도구 불필요
3. Fiori-first UX: GUI transaction 단계적 폐지 (2026년 이후)
4. Real-time Compliance: 검사 완료 즉시 규제 보고 가능

10. Korean Industry & Regulatory Context

10.1 ISO 9001:2015 + IATF 16949 (자동차 심사 기준)

ISO 9001 → SAP QM Mapping:

• Clause 8.6 (Quality evaluation): Inspection Plan (QP01-03), Sampling (QDV1) ✓
• Clause 8.2.3 (Conformance confirmation): UD judgment (QA11-13) ✓
• Clause 8.3 (Non-conforming product): Quality Notification (QM01) ✓

IATF 16949 (자동차 부품) — Auditor 체크리스트:

1. FMEA 추적: Defect code (QMFE) → FMEA ID 매핑 가능?
2. Control Plan 문서: QP01 output과 Control Plan 동일성?
3. Traceability: Lot/Batch → QM lot → Supplier/MFG date 추적 가능?
4. 메트릭 추적: Cpk (공정능력) 계산 가능?

Audit Evidence:

• QP01/QP03 print (검사계획 approved version)
• QMEL closure record (8D compliance)
• ME61 Quality trend (공급사 score 개선 추세)

10.2 한국 제약 GMP (의약품 품질관리기준)

식약처 기준 (GMP Annex 2 — Quality documentation):

1. Sampling Plan 기록:

   Requirement: 최소 3년 보존
   SAP: QP01-QP03 print → PDF archive (DMS 또는 파일시스템)
   Audit: "2023년 X 제품의 검사계획을 보여주세요"
   

2. CoA (Certificate of Analysis):

   Requirement: 모든 원료약 납입 시 CoA 첨부 필수
   SAP: QC01/QC21 자동 생성 + E-signature (Adobe Forms)
   Audit: CoA 발행 이력 + Signed version 보존
   

3. Batch Record (배치 기록):

   Requirement: 생산 전 과정 기록 + QC 결과 통합
   SAP: Production Order (PP) + QM results 연계
        - Z-table 커스터마이즈 또는 SAP Add-on (QMS in S/4)
   Audit: "2023년 Batch A-001의 전체 생산/검사 기록"
   

4. Stability Study:

   Requirement: Long-term stability (3년+) 모니터링
   SAP: QM Lot + Characteristic tracking (X-bar chart)
   Auditor: "Batch A-001의 12개월 마다 검사 결과 추이"
   

Configuration Checklist:

SPRO > SAP Customizing for Quality Management:
  ├─ Industry code: Pharmaceutical
  ├─ GMP compliance flag: X
  ├─ Signature capture: Adobe Forms + digital signing
  └─ Retention: 36 months (자동 archive)

10.3 한국 식품 HACCP (위해요소중점관리기준)

HACCP 12단계 → SAP 매핑:

Configuration:

Material Master (MM02):
├─ CCP flag = "X"
├─ Inspection plan (Type 03): Daily frequency
├─ Automatic alert: Out-of-spec → QM01 Q2 auto-create

SPRO > QM > Define Automatic Notification:
└─ Trigger: QASR (Temperature > 30°C) → Create QM01

10.4 수입검사 (관세청 UNI-PASS 연동)

Regulatory Background (한국):

• 통관 전 품질 증빙 요구 확대 (특히 식품, 화학, 의약품)
• UNI-PASS (통합관세시스템) ↔ SAP QM 연동 필요

SAP Integration Point:

Purchase Order (구매 발주):
├─ Customs declaration (USDOC field, PO header)
├─ Import supplier flag: "I"
└─ Inspection requirement: "Import Inspection"
    ↓
MIGO GR (goods receipt):
├─ Auto-create Inspection Lot (Type 01, Import)
├─ Inspection plan: Source inspection (Type 01 + Supplier)
└─ Block GR posting (차단)
    ↓
QE01 Results recording + UD (QA11):
├─ UD = "A" → Certificate generated (QC21)
├─ Send CoA to customs broker
└─ MIGO posting release → GR completes

Blocking Logic (SPRO customizing):

MIGO-GR Validation:
IF Material.Origin = "Import" AND Supplier.Country != "KR"
THEN Create Inspection Lot (Type 01)
    AND Block MIGO until UD = "A"
    AND Generate CoA (QC21)
    AND Notify customs broker (email extract)

생산 관점: 통관 지연 risk → 재고 운영 계획에 여유(Buffer) 필수

10.5 대기업 협력사 공급망 (삼성/현대)

삼성전자 Quality Requirements:

• Q-rating (3개월 rolling avg) > 98% 필수
• MES ↔ SAP QM 실시간 동기화 요청
• Supplier Portal access (QM data 공개)

현대자동차 Quality Requirements:

• IATF 16949 certification (필수, 미보유 공급사 차단)
• IQMS (In-house QMS) 준수
• Monthly quality review meeting (QM KPI export)

SAP Configuration:

ME61 Vendor Evaluation (자동 계산):
├─ Quality score = (Accepted lots / Total lots) × 100
├─ 3개월 rolling average
└─ Threshold alert: Score < 95%
    → Auto message to procurement manager
    → Recommendation: Reduce PO qty or pause orders

Export for supplier meeting:
├─ SAP Report (ALV format): ZQC_VENDOR_SCORECARD
├─ Data: Last 90 days QM lots, UD distribution, top defects
└─ Distribution: Email to supplier QA manager

한국 특수성: 대기업 공급망 평가 시스템(S-rating, Q-rating)이 SAP와 직결됨

11. Standard Response Format (문제해결 프로세스)

Issue Description

사용자 문제 명확화:

• "검사로트가 생성되지 않음"
• "UD 합격 후에도 GR이 차단되어 있음"
• "CoA가 고객에게 안 보내짐"

Root Cause Analysis (RCA)

Step 1: Data Check (테이블 조회):

• Material master (MM02): QM level 확인 (IQMC field)
• Quality Info Record (QI03): 공급사별 설정 확인 (QZGTP)
• Inspection Plan (QP03): 유효 범위 확인 (GDATU from/to)

Step 2: Configuration Check (SPRO navigat):

SPRO > SAP Customizing for Quality Management:
├─ Automatic Lot Creation Rules
├─ Stock Posting Logic (UD Code A/R/B mapping)
└─ Notification Triggers

Step 3: System Activity Check:

• Background job (SM37): QA25 execution log
• Error log (SM21): System message 확인
• Table data (QALS, QAVE): Expected 데이터 존재 여부

Verification (재현 확인)

• Test material로 end-to-end 시뮬레이션
• Expected behavior vs actual behavior 비교
• Transaction trace (SE39 debug mode)

Fix (시정)

1. Customizing 변경 (Transport request 필요):

   • SPRO에서 설정 변경
   • Transport object 할당
   • Test system 적용 → UAT → Production

2. Master data 수정:

   • MM02 (Material), QI01 (Info Record), QP01 (Inspection Plan)
   • 변경 기록 (SNOW ticket 또는 Change management)

3. ABAP 개발 (필요 시):

   • Z-report, BADi implementation, Enhancement
   • Code review, Unit test, Integration test

Prevention (재발 방지)

1. Documentation:

   • Configuration guide 작성 (SNOW wiki)
   • Process diagram (Inspection lot flow)
   • Master data 준비 checklist

2. Training:

   • 관련자 교육 (Inspection planning, Results recording, UD judgment)
   • Job aid, Screen 캡처

3. Monitoring & Alert:

   • BW query 또는 Fiori tile에서 자동 추적
   • Daily batch job 결과 모니터링
   • Anomaly alert (예: 일일 불합격률 > threshold)

SAP Note Reference

SAP Support Portal (search by keyword):

• 예) "Inspection lot creation fails type 01" → Note 2345678 (applicable SAP version check)
• Apply via SNOTE T-code (transport 자동 생성)

12. References & Deep Dive

Official Documentation

• SAP Help Portal: help.sap.com/docs → QM module
• Quality Management Configuration (ECC): SAP 공식 PDF 가이드
• SAP S/4HANA Quality Management: Best Practices doc (SAP Download Center)

Key Database Tables

Inspection Lot & Results:

• QALS: Inspection Lot Header (LOSNR 로트번호, MATNR 자재)
• QALSD: Lot Defects
• QASE: Sample Header
• QASR: Inspection Result (QMNUM 검사번호)
• QASV: Sample value (characteristic 별 수치)
• QAVE: Usage Decision (최종 판정 A/R/B/S)

Planning & Master:

• PLKO: Inspection Plan Header
• PLPO: Plan Operations
• QPMK: Master Inspection Characteristics
• QPSP: MIC Specification (LSL/USL)
• QDV1: Sampling procedures
• EINA/EINE: Purchasing Info Record (QI01)

Notification & Tracking:

• QMEL: Quality Notification header (통보)
• QMFE: Defect/Cause definition
• QMMA: Activity/Task (시정 조치)
• EIVR: Vendor Evaluation record

Certificate:

• ZQCMO: Certificate master (custom)
• ZQCDR: Certificate data records

Transaction Quick Reference

Further Learning Resources

• SAP QM Workshop: IQMS-SAP 통합 심화 코스
• IATF 16949 Alignment: 자동차 공급망 특화 교육
• Fiori QM Apps Training: QE51N 모바일 검사 hands-on
• GMP Compliance in SAP: 제약 산업 GMP 맞춤 교육

12.1 Common Pitfalls & Solutions

❌ 검사로트 자동 생성 안 됨

확인 순서:

1. Material Master (MM02) → IQMC (QM Control Level) 필드 확인 (빈 값이면 검사 미트리거)
2. Quality Info Record (QI03) → QZGTP (QM control type) 확인
3. Background job QA25 실행 여부 (SM37 check, daily/hourly?)
4. Note: GR 직후 약간의 지연 후 QA25 실행 → QALS 생성 (동기X)

❌ 검사 완료 후에도 GR blocked

원인 후보:

• UD 미생성 → QA11에서 명시적 생성 필수
• UD code "R" (Reject) → Stock blocked
• UD code "B" (Conditional) → Quality hold 해제 필요

해결:

QA11 → Select QALS → Set UD code "A" (Accept)
    ↓
Save → MIGO GR posting 자동 완료

❌ Vendor 평가 점수 안 올라감

확인:

• ME61 거의 실시간 업데이트되지만 계산 기준 재확인
• EIVR (Evaluation record) 직접 조회: T-code SQVI → SELECT * FROM EIVR
• SPRO > MM > Purchasing > Vendor Evaluation 가중치 재확인

❌ 인증서(CoA) 생성 안 됨

원인:

• QC01 profile 미설정
• Material-Certificate 링크 미생성
• SMARTFORM 또는 Adobe Form 프로그래밍 에러

해결:

QC21 → Manual run → Check SM37 job log
    ↓
If error: SM39 (Form Routines debug) 또는 Adobe Form 재컴파일
    ↓
If success: Check DMS/Archive 저장 경로

Document Version: 1.0.0
Last Updated: 2026-04-12
Compatibility: SAP ECC 6.0 SP최신 | S/4HANA 1909+ | S/4HANA Cloud
Target Audience: SAP QM Functional Consultants, Quality Managers, Production Planners, Auditors
Language: English + 한국어 (Industry context)