Are electronic signatures valid?

Yes. Electronic signatures that meet intent, consent, attribution, and record retention requirements are enforceable under the ESIGN Act (15 U.S.C. §7001) and applicable state law such as UETA.

Do QCDs require notarization?

Not usually. Notarization is only needed when the QCD attaches a sworn affidavit or when state law requires notarized acknowledgements for a specific transaction.

How do I meet HIPAA requirements?

Use a signed Business Associate Agreement (BAA), limit PHI in the QCD, apply access controls, and retain records per 45 CFR §164.530(j).

What if a signature is contested?

Provide the audit trail showing signer identity, IP address, timestamp, and authentication method to establish attribution and intent under ESIGN/UETA standards.

Can I revise a signed QCD?

No edits should be made to a signed final. Instead, create an amendment or subsequent QCD referencing the original document and obtain appropriate approvals.

How long must I keep QCDs?

Retention varies. Follow federal minimums (e.g., IRS 3 years under IRC §6501(a)) and longer industry-specific rules such as HIPAA six-year retention where applicable.

Electronic Signature
Templates
Legal
Quality Control Document QCD

Quality Control Document QCD

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Quality Control Document QCD

This Quality Control Document ("QCD") is entered into as of by and between Client Name: with principal place of business at ("Client"), and Supplier Name: with principal place of business at ("Supplier").

RECITALS

WHEREAS, Supplier manufactures or supplies the goods and/or performs the services described in this QCD and any applicable purchase order or specification documents; and

WHEREAS, Client requires that goods and services conform to specified quality standards, inspection regimes and corrective action procedures as a condition of acceptance and payment; and

WHEREAS, the parties desire to set forth the quality control requirements, inspection rights, recordkeeping obligations, and remedies for non-conforming goods or services.

NOW, THEREFORE, in consideration of the mutual covenants set forth below, the parties agree as follows:

1. DEFINITIONS

For purposes of this QCD, the following terms have the meanings set forth below:

"Goods" means the products, components, and materials identified in the applicable purchase order, specification, or the goods_description field below.

Description of Goods/Services

"Specifications" means the written requirements, drawings, tolerances, and performance criteria provided by Client and incorporated into this QCD either by reference or in attachments.

2. QUALITY STANDARDS

Supplier shall ensure that all Goods and Services conform to the Specifications and any additional quality requirements described below. Supplier warrants that all delivered Goods and performed Services will be free from defects in materials, workmanship, and design for the warranty period specified in Section 8.

Additional Quality Requirements / Acceptance Criteria

3. INSPECTION AND ACCEPTANCE

Client shall have the right to inspect, test and audit Supplier's facilities, processes and Goods at reasonable times and upon reasonable notice. Inspection may be performed at Supplier's facility, during transit or at Client's site. Acceptance shall occur only after successful completion of the agreed inspection and testing or upon Client's written acceptance.

Inspection / Acceptance Period (days)

4. NON-CONFORMANCE AND CORRECTIVE ACTION

If Client identifies non-conforming Goods or Services, Client shall notify Supplier in writing specifying the nature of the non-conformance. Supplier shall, at its expense and within the timeframes required herein, correct the non-conformance through repair, replacement, rework or other agreed corrective measures. Supplier's failure to correct non-conformances within the required period shall entitle Client to pursue remedies including rejection, price reduction, repair by a third party at Supplier's expense, or termination for cause.

Notification Period for Non-Conformance (days) Corrective Action Process

5. CHANGE CONTROL

Supplier shall notify Client in writing of any proposed changes to materials, manufacturing processes, inspection methods, suppliers, or Specifications that may affect conformity. No change affecting fit, form, function or quality shall be implemented without Client's prior written approval. Approved changes shall be documented and included as revisions to the applicable Specifications.

Change Control Procedures

6. RECORDS AND REPORTING

Supplier shall maintain complete and accurate records of inspections, tests, fabrication, receipts, non-conformances and corrective actions for the retention period specified below. Upon request, Supplier shall provide copies of such records to Client and permit Client or its representatives to review originals during normal business hours.

Records Retention Period

7. AUDITS AND ACCESS

Client, or Client's authorized auditors, shall have the right to audit Supplier's relevant facilities, records and processes to verify compliance with this QCD. Supplier shall provide reasonable access and cooperation. Any third-party audits shall be conducted upon reasonable notice and at Client's expense unless non-conformity is found, in which case Supplier shall bear the cost of the audit.

Audit Notice Period (days) Third-Party Audit Permitted

Yes — Supplier consents to third-party audits as set forth above.

8. WARRANTIES; REMEDIES

Supplier expressly warrants that all Goods and Services shall conform to the Specifications and be merchantable, fit for the intended purpose, and free of defects. The warranty period shall be the longer of the period set forth in the purchase order or the warranty_period_months specified below, commencing on the date of acceptance by Client.

Warranty Period (months)

Client's remedies for breach of Supplier's warranties include: (a) requiring repair or replacement of non-conforming Goods or re-performance of non-conforming Services at Supplier's expense; (b) recovery of reasonable costs incurred by Client to effect correction; and (c) rejection and return of non-conforming Goods for full refund. Such remedies are cumulative and in addition to any other rights or remedies available at law or equity.

9. LIMITATION OF LIABILITY

Except for liability arising from Supplier's willful misconduct, gross negligence, or Supplier's indemnification obligations, neither party shall be liable for consequential, incidental, special, punitive or exemplary damages arising out of or related to this QCD. The parties' aggregate liability arising out of or related to this QCD shall not exceed amounts paid or payable under the applicable purchase order during the twelve (12) months preceding the claim.

10. INDEMNIFICATION

Supplier shall indemnify, defend and hold harmless Client and its affiliates, officers, directors and employees from and against any third-party claims, losses, liabilities, damages and expenses (including reasonable attorneys' fees) arising out of Supplier's breach of this QCD, negligence, willful misconduct, or failure to meet Specifications.

11. TERM AND TERMINATION

This QCD shall remain in effect for the term specified below for the related purchase orders or until earlier termination pursuant to this Section. Either party may terminate this QCD for material breach by the other party if the breaching party fails to cure such breach within the termination_notice_days specified below after receipt of written notice.

Related Term (months) Termination Cure Period (days)

12. NOTICES

All notices under this QCD shall be in writing and delivered by hand, certified mail (return receipt requested), or recognized overnight courier to the addresses set forth below or to such other address as a party may designate by written notice.

Client Notice Address Supplier Notice Address

13. GOVERNING LAW; VENUE

This QCD shall be governed by and construed in accordance with the laws of the state specified below without regard to conflict of law principles. The parties submit to the exclusive jurisdiction of the state and federal courts located in such state for resolution of disputes arising under this QCD.

Governing Law (State)

14. ENTIRE AGREEMENT; AMENDMENT; WAIVER; SEVERABILITY; COUNTERPARTS

This QCD, together with the applicable purchase orders and Specifications expressly incorporated herein, constitutes the entire agreement between the parties with respect to quality control obligations and supersedes all prior and contemporaneous agreements, representations and understandings. Any amendment or modification to this QCD must be in writing and signed by authorized representatives of both parties. Failure to enforce any provision of this QCD shall not constitute a waiver of future enforcement. If any provision of this QCD is held invalid or unenforceable, the remaining provisions shall remain in full force and effect. This QCD may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument.

Client:

By:

Date:

Supplier:

By:

Date:

What the Quality Control Document QCD Is and Why It Matters

The Quality Control Document (QCD) is a structured report used to record inspection results, nonconformances, corrective actions, and verification steps for products, processes, or services. It standardizes acceptance criteria, documents test data, and creates an auditable trail showing who reviewed items, when checks were performed, and what remediation occurred. Organizations use a QCD to demonstrate consistent quality practices, support regulatory audits, and maintain a repeatable record that links issues to root-cause analysis and closure. A clear QCD reduces ambiguity and helps maintain continuous improvement across teams.

Key Reasons to Use a Quality Control Document QCD

A QCD centralizes inspection data and corrective actions so teams can verify compliance, measure failure trends, and produce evidence for audits under industry or federal rules such as HIPAA or FDA controls when applicable.

Who Typically Completes the Quality Control Document QCD

Multiple roles may prepare or sign a QCD depending on industry and internal controls:

Quality assurance technicians and inspectors who perform hands-on checks and record measurements, samples, and pass/fail status during production or receipt inspections.
Operations managers and supervisors who review findings, approve corrective actions, and escalate nonconformances to engineering or compliance teams.
Regulatory and compliance staff who validate that records meet audit requirements and that corrective actions satisfy applicable standards and regulations.

Ownership and signature authority should be defined in the document header so reviewers know who may approve, reject, or accept items listed in the QCD.

Primary Signers and Their Roles

QA Manager

Responsible for final acceptance of inspection results, reviewing corrective action plans, and ensuring closure. The QA Manager verifies records, signs the QCD to confirm compliance, and retains oversight of trend data and nonconformance metrics.

Operations Lead

Conducts or validates frontline inspections, documents test results and immediate actions, and signs to confirm operational readiness. The Operations Lead coordinates with maintenance and engineering to implement fixes and update process controls.

Essential Sections to Include in a Professional QCD

A complete QCD groups inspection metadata, measured results, deviations, corrective actions, verification steps, and final disposition so reviewers can follow the lifecycle of each finding.

Header Data

Document ID, revision, location, inspector name, department, and date provide traceability and link records to production lots or batches.

Inspection Criteria

List the specific acceptance criteria, referenced standard or drawing, equipment used, measurement tolerances, and sampling plan used during the check.

Measured Results

Record numeric readings, pass/fail flags, observations, photos, and evidence so subsequent reviewers can verify the original measurement and reproduce testing if needed.

Nonconformance Details

Describe deviation severity, root-cause hypotheses, affected lots or serial numbers, and immediate containment actions taken to prevent recurrence.

Corrective Action

Assign responsible party, due date, action description, and verification method to close the loop on corrective measures and document effectiveness checks.

Signatures & Audit Trail

Include role-based sign-off fields, reviewer comments, and a timestamped audit trail that records who changed or approved entries for compliance and dispute resolution.

Step-by-Step: Completing the QCD from Start to Finish

Follow these sequential steps to ensure consistent completion, accurate evidence capture, and proper sign-off for each inspection event.

01

Prepare Document: Select correct QCD template and revision.
02

Record Metadata: Fill batch, lot, inspector, and date fields.
03

Perform Inspection: Capture measurements, photos, and observations.
04

Sign & Archive: Obtain required signatures and save final QCD.

Configuring an Online QCD Workflow

Set up a repeatable digital workflow that enforces required fields, assigns reviewers, and preserves an immutable audit trail for each QCD submission.

Field	Configuration
Required Fields	Make inspector, date, and measurements mandatory.
Approval Order	Assign QA Manager then Operations Lead as approvers.
Notifications	Email or SMS alerts for new QCDs and overdue actions.
Retention Tag	Apply retention classification and access controls.

Where to File or Send a Completed QCD

A completed QCD should route to the document repository, assigned approvers, and any regulatory folders while preserving an audit trail for each transfer.

Document Repository: Save signed QCD to your controlled record system (PDF/A preferred).
Approver Inbox: Send a review task to the QA Manager and Operations Lead.
Compliance Archive: Copy final QCD into audit and regulatory folders.
External Parties: Share redacted QCDs with suppliers or customers as required.

Digital Signing and eSubmission Considerations

Use an eSignature platform that records signer identity, timestamps, and an immutable audit trail to preserve legal validity.

Authentication: Email, SMS, or advanced methods like KBA or SSO.
File Formats: Accepts PDF, DOCX, and preserves embedded evidence.
Integrations: Connects with systems such as Salesforce and NetSuite.

Ensure the chosen platform supports retention controls, optional BAAs for HIPAA, and export of a certificate of completion for each signed QCD.

Timelines and Processing Expectations for QCDs

Establish clear response and closure deadlines to manage corrective actions and regulatory reporting obligations tied to inspection findings.

Immediate Containment:

Address safety-critical findings within 24 hours.

Corrective Action Plan:

Submit responsible owner and plan within 5 business days.

Verification:

Complete effectiveness checks within 30 days.

Final Sign-off:

QA Manager signs after verification and closure.

Regulatory Reporting:

Report incidents per agency deadlines when required.

Key Milestones in QCD Processing

Track milestone events from inspection to archival to ensure timelines are met and audit evidence is complete.

01

Inspection Performed

Measurements and evidence captured at the test date.

02

Nonconformance Logged

Deviation recorded and severity classified promptly.

03

Action Assigned

Corrective steps allocated with due dates.

04

Closure Verified

Verification completed and final sign-off recorded.

Common Mistakes When Preparing a QCD

Entering incomplete metadata, which breaks traceability between the QCD and production lot or batch numbers, delaying audits and investigations.
Failing to record measurement units or precision, causing ambiguity that can lead to rework or contested inspection outcomes.
Delaying corrective action assignment or missing due dates, which compounds quality issues and increases regulatory risk.
Using unsigned or unverified signatures, which may render the QCD noncompliant with ESIGN/UETA standards for electronic records.

Penalties and Risks from Incorrect or Missing QCDs

Operational Risk: Production delays or recalls.

Regulatory Fines: Enforcement actions and monetary penalties.

Safety Incidents: Increased risk of harm to users or staff.

Contract Disputes: Claims and liability exposure.

HIPAA Violations: Patient data breaches where applicable.

Audit Findings: Negative audit reports and remediation orders.

eSignature Vendor Comparison for QCD Workflows

Compare basic pricing and feature availability across common eSignature vendors. signNow appears first to show its entry-level pricing and capabilities.

	signNow	DocuSign	Adobe Sign	PandaDoc	HelloSign
Starting Price	$8/user/mo	$15/user/mo	$14/user/mo	$19/user/mo	$15/user/mo
Free Trial	7-day trial	Yes, trial	Yes, trial	Yes, trial	Yes, trial
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
Envelope Cap	No cap	100 envelopes/user/year	Varies by plan	Varies by plan	Varies by plan

Real-World Examples of QCD Use

These short case arcs show how organizations apply QCDs to streamline inspections, approvals, and audit readiness.

Optica Ventures — COO

Optica centralized inspection reports into a single QCD template to reduce ambiguity and speed reviews.

The team automated routing to approvers.
As a result, turnaround improved, handoffs were clearer, and customer-facing response times shortened while preserving an auditable trail for each shipment.

Tech Data — CEO

Tech Data integrated QCDs with their ERP to attach batch IDs and photographs automatically.

Integration reduced manual entry.
The result was fewer data errors, faster reconciliation, and clear evidence for compliance teams during internal and external audits.

Frequently Asked Questions About the Quality Control Document QCD

Answers to typical questions about signature validity, retention, and getting QCDs accepted by auditors or customers.

Need help? Contact support

Are electronic signatures valid?
Yes. Electronic signatures that meet intent, consent, attribution, and record retention requirements are enforceable under the ESIGN Act (15 U.S.C. §7001) and applicable state law such as UETA.
Do QCDs require notarization?
Not usually. Notarization is only needed when the QCD attaches a sworn affidavit or when state law requires notarized acknowledgements for a specific transaction.
How do I meet HIPAA requirements?
Use a signed Business Associate Agreement (BAA), limit PHI in the QCD, apply access controls, and retain records per 45 CFR §164.530(j).
What if a signature is contested?
Provide the audit trail showing signer identity, IP address, timestamp, and authentication method to establish attribution and intent under ESIGN/UETA standards.
Can I revise a signed QCD?
No edits should be made to a signed final. Instead, create an amendment or subsequent QCD referencing the original document and obtain appropriate approvals.
How long must I keep QCDs?
Retention varies. Follow federal minimums (e.g., IRS 3 years under IRC §6501(a)) and longer industry-specific rules such as HIPAA six-year retention where applicable.

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