Quality
Deviations and CAPA
Record deviations, assess their impact, and open a corrective and preventive action when one is needed. CAPAs are reviewed and approved, with reminders before they fall due.
- Deviations 15 columns · IDs like DEV-0001 · signed: QA approval
- CAPA 13 columns · IDs like CAPA-0001 · signed: Reviewed by, Approved by
- Reminder: Deviation due in 3 days
- Reminder: Deviation overdue
- Reminder: CAPA due in 3 days
- Reminder: CAPA overdue
21 CFR 211.192 · FDA QMSR (21 CFR 820) · ISO 13485 §8.5.2 · ISO 9001 §10.2 · EU GMP Ch. 1
Quality
Nonconformances
Product or material that doesn't meet requirements: identify it, decide its disposition, and get it approved.
- Nonconformances 14 columns · IDs like NC-0001 · signed: Disposition approved by
- Reminder: Nonconformance due in 3 days
- Reminder: Nonconformance overdue
ISO 9001 §8.7 · ISO 13485 §8.3 · FDA QMSR (21 CFR 820) · AS9100 §8.7 · IATF 16949 §8.7
Quality
Change control
Propose, assess and approve changes to processes, equipment, materials or documents before they're made.
- Change requests 13 columns · IDs like CC-0001 · signed: Assessed by, Approved by
- Reminder: Change due in 3 days
- Reminder: Change overdue
FDA QMSR (21 CFR 820) · ISO 13485 §7.3.9 · ISO 9001 §6.3 · EU GMP Annex 15 · ICH Q10
Quality
Document control (SOPs)
Controlled documents with versions, review and approval. Each document gets a periodic review date two years ahead, and its owner is reminded a month before it's due.
- Documents 11 columns · IDs like DOC-0001 · signed: Reviewed by, Approved by
- Reminder: Periodic review due in 30 days
21 CFR 211.100 · FDA QMSR (21 CFR 820) · ISO 9001 §7.5 · ISO 13485 §4.2.4 · ISO/IEC 17025 §8.3
Quality
Training records
Who was trained on what, when, and by whom, with trainee and trainer sign-off and reminders when training falls due.
- Training records 10 columns · IDs like TRN-0001 · signed: Trainer sign-off
- Reminder: Training due in 7 days
- Reminder: Training overdue
21 CFR 211.25 · FDA QMSR (21 CFR 820) · ISO 9001 §7.2 · ISO 13485 §6.2 · ISO/IEC 17025 §6.2
Quality
Complaints
Customer complaints from receipt to closure: investigation, reportability decision, response, and QA approval.
- Complaints 13 columns · IDs like CMP-0001 · signed: Closed by QA
- Reminder: Complaint due in 3 days
- Reminder: Complaint overdue
21 CFR 211.198 · FDA QMSR (21 CFR 820) · ISO 13485 §8.2.2 · ISO 9001 §9.1.2
Quality
Internal audits
An internal audit program: each audit's scope, criteria and auditor, the report approved by Quality, and findings followed up to closure with owners, due dates and reminders.
- Audits 11 columns · IDs like AUD-0001 · signed: Report approved by
- Findings 13 columns · IDs like FND-0001 · signed: Effectiveness verified by
- Reminder: Audit in 7 days
- Reminder: Finding due in 3 days
- Reminder: Finding overdue
ISO 9001 §9.2 · ISO 13485 §8.2.4 · IATF 16949 §9.2.2 · AS9100 §9.2 · ISO/IEC 17025 §8.8
Quality
8D problem solving
Customer and internal problems worked through the eight disciplines, from the team and containment to root cause, permanent corrective action and preventing recurrence, approved by Quality, with reminders before the due date.
- 8D reports 16 columns · IDs like PS-0001 · signed: Approved by
- Reminder: 8D report due in 3 days
- Reminder: 8D report overdue
IATF 16949 §10.2.3 · ISO 9001 §10.2 · AS9100 §10.2
Quality
Risk management (ISO 14971)
A risk register per product: hazards, hazardous situations and harms, severity and probability before and after risk controls, verification of the controls, and Quality's approval, with a yearly review.
- Risk register 20 columns · IDs like RSK-0001 · signed: Approved by
- Reminder: Risk review due in 30 days
ISO 14971:2019 · ISO 13485 §7.1 · FDA QMSR (21 CFR 820) · EU MDR Annex I
Operations
Equipment and calibration
An equipment register with calibration records reviewed by Quality, and reminders two weeks before calibration falls due.
- Equipment 8 columns · IDs like EQ-0001
- Calibrations 9 columns · IDs like CAL-0001 · signed: Reviewed by
- Reminder: Calibration due in 14 days
- Reminder: Calibration overdue
21 CFR 211.68 · FDA QMSR (21 CFR 820) · ISO 9001 §7.1.5 · ISO/IEC 17025 §6.4 · ISO 13485 §7.6
Operations
Supplier qualification
Approved suppliers with their risk, certificates and qualification, approved by Quality and requalified every year.
- Suppliers 10 columns · IDs like SUP-0001 · signed: Approved by
- Reminder: Requalification due in 30 days
FDA QMSR (21 CFR 820) · ISO 9001 §8.4 · ISO 13485 §7.4 · AS9100 §8.4 · EU GMP Ch. 5
Operations
Inventory and lots
An item master, lots with expiry dates and storage locations, a Quality release before stock is used, a log of every receipt and use, and reminders before lots expire.
- Items 9 columns · IDs like ITM-0001
- Lots 14 columns · IDs like LOT-0001 · signed: Released by
- Stock movements 8 columns · IDs like MOV-0001
- Reminder: Lot expires in 30 days
- Reminder: Lot expired
21 CFR 211.80 · 211.84 · 211.122 · FDA QMSR (21 CFR 820) · ISO 13485 §7.4 · §7.5.5 · ISO/IEC 17025 §6.6
Operations
First article inspection (AS9102)
First article inspection reports following AS9102: part number accountability, materials, special processes and functional tests, and each design characteristic measured against its requirement (pass or fail is calculated), approved by Quality.
- First articles 15 columns · IDs like FAI-0001 · signed: Approved by
- Characteristics 12 columns · IDs like CHR-0001
AS9102 · AS9100 §8.5.1.3 · IATF 16949 §8.6.2
Lab
Sample log and results
Receive samples with unique IDs and storage locations, record test results against specifications (pass or fail is calculated), and have them reviewed.
- Samples 10 columns · IDs like SMP-0001
- Results 12 columns · IDs like RES-0001 · signed: Reviewed by
- Reminder: Report due tomorrow
ISO/IEC 17025 §7.4 · §7.5 · §7.8 · 21 CFR 211.194 · GLP (21 CFR 58)
Lab
Test requests and reports (ISO/IEC 17025)
Customer test requests reviewed before work starts, and test reports authorized by a signature before they're released, linked to each other, with reminders before a report is due.
- Test requests 13 columns · IDs like REQ-0001 · signed: Request reviewed by
- Test reports 8 columns · IDs like RPT-0001 · signed: Authorized by
- Reminder: Report due in 2 days
ISO/IEC 17025 §7.1 · ISO/IEC 17025 §7.8 · ISO/IEC 17025 §7.5
Food safety
HACCP monitoring log
Monitor critical control points, signed and dated when they're made, with a corrective action opened whenever a limit isn't met and daily verification.
- CCP monitoring 11 columns · IDs like MON-0001 · signed: Verified by
- Corrective actions 9 columns · IDs like CA-0001 · signed: Verified by
21 CFR 117 Subpart C · 21 CFR 120 · Codex HACCP · SQF · BRCGS
Food safety
Sanitation and pre-op inspections
Pre-operational inspections of each area before production starts, signed and dated when they're made, with a corrective action opened whenever an area fails and re-inspection before release.
- Pre-op inspections 10 columns · IDs like PRE-0001 · signed: Verified by
- Sanitation corrective actions 8 columns · IDs like SCA-0001 · signed: Verified by
21 CFR 117.35 · 21 CFR 117.80 · SQF · BRCGS
Signatures, reminders and links between tables are set up for you. A template's groups (such as Quality Assurance) are created when an admin installs it; add your people to them.
