WSM QualityOS

Deviation Detail

J.213.192.2 — QUALITY INVESTIGATION REPORT

File New Deviation

F.213.100.2 — REQUESTS FOR DEVIATIONS

Batch Affected

Severity *

Description *

Immediate Action Taken

CAPA Owner

🔐

Sign Deviation Record

21 CFR Part 11 — your signature files this deviation under your account

??

—

Password to Sign

✅

—

Create New User

USER MANAGEMENT · 21 CFR PART 11 ACCESS CONTROL

Full Name *

Username * (no spaces)

Password *

Confirm Password *

Role *

Department

🔐

Administrator Authorization Required

Admin password required to create new system users — 21 CFR Part 11

??

—

Admin Password

✅

—

Report Preview & Sign

SIGN BELOW TO AUTHORIZE — 21 CFR PART 11

🔐

Authorize Report Generation

Your e-signature will appear as the authorizing officer

??

—

Password to Authorize

✅

—

Register New Container

CONTAINER REGISTRY · DOT / ISO TRACKING

🪣 Container Identification

or enter manually below

Serial Number / Label ID *

Division *

Container Type *

Manufacturer Part # *

Gas Service *

Alloy / Material

Service Pressure (PSI)

Water Capacity (L)

📋 DOT / Inspection Data

DOT Specification

Manufacturer / Mfr Date

Last Hydrostatic Test

Next Hydrostatic Due

Retest Interval

Status

Current Location

Owner / Customer

Notes

🔐

Sign Container Registration

Your signature registers this container — 21 CFR Part 11 / DOT Tracking

??

—

Password to Sign

✅

—

CUSTOMER MANAGEMENT · DISTRIBUTION & TRACEABILITY

Customer Name *

Customer Type *

Label Type *

Contact Person

Phone

Email

Account Number

Delivery Address

City

State / ZIP

Gases Purchased

CoA Required

Notes / Special Requirements

Record Delivery

BATCH → CUSTOMER ASSIGNMENT · TRACEABILITY

Customer *

Batch Number *

Gas

Cylinders Delivered

Delivery Date

Driver / Delivery Person

Purchase Order #

CoA Sent

Delivery Notes

🔐

Sign Delivery Record

Your signature records this delivery — Chain of custody

??

—

Password to Sign

✅

—

Qualify New Supplier

E.213.82.1 -- SUPPLIER QUALIFICATION PROCEDURE

🏢 Company Information

Supplier Name *

Website

Primary Contact *

Contact Email *

Phone

Country

⚗️ Regulatory Info

Gases / Products Supplied * (Ctrl/Cmd = multi-select)

NDA / NADA Number *

Supplier Type

CoA Provided

CoAs on File

📋 Qualification Assessment

Last Audit Date

Next Audit Due

QA Score (%)

Status *

Notes / Conditions

✍️ Electronic Signature -- 21 CFR Part 11

🔐

Sign Supplier Qualification Record

Your signature certifies this supplier was assessed per E.213.82.1 and enters them into the ASL

??

--

Password to Sign

✅

--

New Order Entry

CUSTOMER ORDER · PURCHASE ORDER · WORKFLOW INITIATION

📋 Order Source & Customer

Order Type *

Customer *

PO Number / Reference

PO Date / Request Date

Urgency

Required Delivery Date

⚗️ Order Items

Gas Product

Mixture Grade Required

Cylinder Part #

Quantity (cylinders)

Purity / Specification

📝 Additional Info

Notes / Special Requirements

New EPA Protocol Assay

EPA/600/R-12/531 · PROCEDURE G1 / G2 / G3 · PGVP: WSM-FL-001

🧪 Candidate Standard

Cylinder Serial Number *

Container ID

Gas Component *

Balance Gas

Target Concentration *

Units

Assay Procedure *

Cylinder Pressure (psig)

📊 Reference Standard -- §2.1.3

Reference Standard Type *

SRM / ID Number *

Lot / Sample Number

Certified Concentration

Ref. Uncertainty U (k=2)

Ref. Standard Expiration

🔬 Assay 1 Results -- §2.1.5

Assay Date *

Measurement 1 *

Measurement 2 *

Measurement 3 *

Measurement 4 (opt)

Measurement 5 (opt)

Multipoint Cal. Instrument & Date

Zero/Span Relative Difference (%)

ℹ️

Reactive Gases — Second Assay Required (§2.1.5.2)NO, SO₂, H₂S, NH₃, NOₓ, HCl require a 2nd assay ≥7 days after Assay 1. The system will flag this assay for Assay 2 entry. TOST will be calculated automatically once both assays are entered.

Tolerance Quick Check

VERIFY ANALYTICAL RESULT AGAINST WSM SPECIFICATIONS

📊 Check Parameters

Mixture Grade *

Certified (Target) Concentration *

Measured Analytical Result *

Units

Record New Laboratory Analysis

§ 213.160 · LABORATORY CONTROLS · TOLERANCE VALIDATED

🧪 Sample & Mixture Identification

Batch Number *

Gas / Product *

Mixture Grade *

Division

📊 Analytical Results — Live Tolerance Check

Certified (Target) Concentration

Measured Result *

Units

CO (ppm)

CO₂ (ppm)

H₂O (ppm)

Additional Component (opt.)

Instrument Used

${esigBlock("lab-anlys","la","Analyst Electronic Signature","Sign to certify accuracy of analytical results — ALCOA Attributable & Accurate")}

New Special Gas Formulation

ISO 6142-1/2 · GRAVIMETRIC OR MANOMETRIC · BLENDING RECORD

⚗️ Product Identification

Product Name *

Mixture Grade *

Blending Method *

Cylinder Serial Number *

Cylinder Part # (from registry)

Target Concentration *

Units

Balance Gas

Certification Period (years)

⚖️ Component Details (add each component)

Component Name *

Target Concentration (ppm)

Target Weight (g)

Actual Weight (g)

Component Purity (%)

Type

🧪 Cylinder Preparation

Cylinder Treatment

Vacuum Level Achieved

Blend Date *

Incubation End (auto: +4 days)

🔐

Sign Formulation Record

Your signature as blending operator — ISO 17025 / 21 CFR Part 11

??

—

Password to Sign

✅

—

Record Special Gas Assay

ISO 17025 · NIST TRACEABLE ANALYSIS · PROCEDURE G1/G2

⚗️

Formulation: — —

📊 Reference Standard Used

Ref. Standard Type *

Standard ID / Number

Certified Concentration

U Reference (k=2)

🔬 Assay Measurements (min. 3 discrete readings)

Assay Date *

Instrument Used

Zero/Span Drift (%)

Measurement 1 *

Measurement 2 *

Measurement 3 *

Measurement 4

Measurement 5

Assay Number

🔐

Analyst Electronic Signature

ISO 17025 — certifies accuracy and traceability of this assay

??

—

Password to Sign

✅

—

Update Supply Reading

SUPPLY SOURCE

🏭

—Record current level / pressure reading. History is tracked automatically.

📋 Current Reading

Operating Pressure (PSI) *

Daily Boil-off Rate (% / day)

Delivery Volume (gallons) — if delivery today

Current Pressure (PSI) *

Note

Add Custom Purity Grade

GRADE MANAGER · ADD FOR ANY GAS · IMMEDIATE EFFECT

⚙️

Custom Grade Add a new purity grade (e.g. Pure Clean, Zero Grade, Instrument Grade) for any gas. It will appear immediately in analysis forms, CoA, and grade selectors.

📋 Grade Identification

Gas *

Grade ID (internal key) * Lowercase, no spaces. Used internally.

Grade Label (display name) *

Description

Color Theme

📊 Purity Specification Limits (ppmv)

Minimum Purity (%) *

Max O₂ (ppmv)

Max H₂O (ppmv)

Max THC (ppmv)

Max CO (ppmv)

Max CO₂ (ppmv)

Max N₂ (ppmv)

Max Ar (ppmv)

Notes / Reference

New Manufacturing Job

SPECIAL GAS · CYLINDER ASSIGNMENT · WORKFLOW INITIATION

🏭

Assign a cylinder and start the production workflow Once created, the job moves through: Assignment → Baking → Passivation → Filling → Homogenization → Analysis → [Quarantine] → Release

📦 Cylinder & Product

Cylinder Serial Number *

Cylinder Part #

Link to Formulation (optional)

Product Name *

Gas Component *

EPA Protocol Gas?

Order Reference

Assigned Operator *

Scan Cylinder at Station

BARCODE · DATE · TIME · OPERATOR AUTO-LOGGED

📷

Scan the cylinder barcode to log station arrival System records: station, timestamp (${new Date().toISOString().slice(0,16).replace('T',' ')} UTC), operator (${CU?.name||'—'}). Cylinder advances to next stage automatically.

📷 Scan or Enter Cylinder

Cylinder Serial Number *