qms-supplier

Supplier Quality

Qualify. Monitor. Improve.

The supplier nobody was watching. 12 lots rejected. 3 SCARs still open. Acceptance dropped from 94% to 87%. The data was there—nobody connected it into a picture.

The supplier nobody was watching.

ABC Materials had been your API supplier for three years. Qualification was thorough—audited their facility, reviewed their quality system, tested initial lots. Everything passed.

Over the next three years: 12 lots rejected at incoming inspection. 3 SCARs issued, 2 still open from last year. 4 audit observations, 2 unresolved. Quality trending downward—94% acceptance rate two years ago, 87% last quarter.

The data was all there. Nobody had connected it into a picture.

Supplier Scorecard

Then Lot 2024-103 failed release testing. The investigation traced the failure to the API. This wasn't a sudden problem—it was the latest data point in a three-year decline.

The supplier lifecycle

Supplier lifecycle

Identification → Qualification → Onboarding → Monitoring → Development → Exit.

Most organizations handle the first three phases reasonably well. They fail at monitoring because they lack the data to understand supplier performance over time.

Incoming inspection

Reduced inspection for suppliers with strong track records. Tightened inspection when problems emerge. Skip lot for highly reliable suppliers and non-critical materials.

When incoming inspection finds a problem, the system can automatically tighten inspection for that supplier.

CoA verification

Suppliers provide CoAs claiming their material meets specifications. Seal compares CoA data to your specifications automatically. If the CoA shows a result outside your acceptance criteria, the system flags it—even if the supplier considers it acceptable.

SCARs

When supplier quality fails: document the issue, notify the supplier, evaluate their response, verify effectiveness.

Seal tracks SCARs from initiation through closure, with escalation when suppliers don't respond. You can see which suppliers have open SCARs, which are overdue, which have recurring issues.

Performance scorecards

Computed automatically from actual transaction data: on-time delivery rate, incoming inspection pass rate, SCAR response time. A supplier trending downward on quality triggers review. A supplier with strong performance qualifies for reduced inspection.

Capabilities

01Approved Supplier List
Living ASL with qualification status, material scope, and quality agreements. Only approved suppliers can provide manufacturing materials.
02Risk-Based Qualification
Different rigor for different risk levels. Critical suppliers get full audits; minor suppliers get streamlined review.
03Incoming Inspection
Sampling plans by supplier and material. Automatic adjustment based on performance history.
04CoA Verification
Compare supplier certificates to your specifications automatically. Flag discrepancies before material enters inventory.
05SCAR Management
Track supplier corrective actions from issue through verification. Escalate when responses are overdue.
06Performance Scorecards
Objective metrics computed from actual data. Delivery, quality, and SCAR performance at a glance.
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Approved Supplier List
Approved Supplier List

Entities

Entity
Description
Kind
Supplier
Your product is only as good as your materials. One contaminated lot destroys a batch.
type
Critical Supplier
API supplier. Full qualification, annual audit. On-site assessment of facility and systems.
template
ABC Materials Inc.
API supplier three years. 12 lots rejected. 3 SCARs. 4 audit observations. Lot 2024-103 caused the recall.
instance
Standard Supplier
Excipients, packaging. Desktop qualification, periodic review.
template
Performance Scorecard
94% acceptance two years ago. 87% last quarter. The data was there. Nobody connected it into a picture.
type
ABC Scorecard
Delivery: 91%. Quality: 87% (was 94%). SCAR response: 2 open >90 days. Pattern clear. Action overdue.
instance
SCAR
Supplier Corrective Action. 3 issued, 2 still open from last year. Escalate when suppliers don't respond.
type
Qualification
Qualification is easy. Monitoring is where organizations fail. The data shows performance over time.
type
Incoming Inspection
Reduced, normal, tightened, skip lot. Level adjusts automatically based on performance. Trust built on evidence.
type
Quality Agreement
Formal expectations. When you need to check what's covered, one click away.
type
Change Notification
Supplier changed their process. External change triggers your internal response.
type

FAQ

Each supplier-material combination can have different qualification requirements and inspection levels. A supplier might be approved for one material but pending qualification for another. The system tracks this at the material level, not just the supplier level.