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Quality Assurance Questionnaire

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QUALITY ASSURANCE QUESTIONNAIRE

This Quality Assurance Questionnaire (the Agreement) is entered into as of by and between:

Client Name:

Provider Name:

WHEREAS

WHEREAS, Client requires quality assurance review and verification services for the Project identified below; and

WHEREAS, Provider represents that it possesses the expertise, personnel, and systems necessary to perform the quality assurance services described herein; and

WHEREAS, the parties intend by this Agreement to set forth the Scope of Work, Payment Terms, confidentiality obligations, and other terms governing Provider's performance of quality assurance activities.

PROJECT IDENTIFICATION

SCOPE OF WORK

Provider shall perform quality assurance activities, inspections, testing, documentation review, and corrective action verification applicable to the Project. Provider's services shall include, at a minimum, the following:

QUALITY ASSURANCE CHECKLIST

For each item below, check the applicable box and provide comments where needed. Provider must retain supporting evidence and documentation for all affirmative checks.

1. Conformance to Specifications

2. Documentation Completeness

3. Functional Testing / Performance

4. Safety and Regulatory Compliance

CORRECTIVE ACTIONS

For any non-conformances identified, Provider shall document corrective actions, assign responsibility, and verify closure within the schedule below.

PAYMENT TERMS

Client shall pay Provider for the services performed under this Agreement in accordance with the following payment provisions.

TERM AND TERMINATION

This Agreement commences on: and continues until:

Either party may terminate this Agreement for cause upon written notice if the other party materially breaches any provision and fails to cure within days after receipt of such notice. Termination for convenience by Client requires days' prior written notice.

CONFIDENTIALITY

Each party shall maintain in confidence all Confidential Information disclosed by the other party and shall not disclose such information to third parties except as required by law or as necessary to perform its obligations under this Agreement. "Confidential Information" includes technical data, specifications, test results, business or financial information, and any other non-public information designated as confidential or that a reasonable person would understand to be confidential given the nature of the information.

The obligations of confidentiality shall survive termination of this Agreement for a period of three (3) years, except for trade secrets which shall be protected to the extent permitted by applicable law.

GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the State of without regard to its conflict of laws principles.

ENTIRE AGREEMENT

This Agreement, including any attachments and any Scope of Work described herein, constitutes the entire agreement between the parties with respect to its subject matter and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether oral or written. Any amendment or modification must be in writing and signed by authorized representatives of both parties.

ATTACHMENTS AND EVIDENCE

Provider shall attach or reference supporting evidence for all checklist items, including test records, photographs, inspection logs, and corrective action documentation. List attached items below.

CERTIFICATION

The undersigned certify that the information contained in this Questionnaire is accurate and complete to the best of their knowledge and that the Provider performed the described quality assurance activities in accordance with this Agreement and applicable standards.

Client:

By:

Date:

Provider:

By:

Date:

Enter text✕

What the Quality Assurance Questionnaire Is and When It’s Used

A Quality Assurance Questionnaire is a structured, itemized form used to evaluate processes, products, services, or supplier performance against defined quality standards. It collects factual responses on procedures, controls, test results, nonconformances, corrective actions, and responsible parties to support audits, regulatory reviews, vendor qualification, and continuous improvement. In practice it serves as both a data-collection tool and an audit record, often incorporated into supplier onboarding, internal audits, release checks, or post-incident reviews. The form may be submitted electronically and retained as part of the quality management system.

Why a Quality Assurance Questionnaire Matters

A QA Questionnaire standardizes inspections, reduces subjective reporting, and creates a traceable record for compliance, corrective actions, and performance tracking. It improves consistency across teams and provides evidence for audits and regulatory inspections.

Why a Quality Assurance Questionnaire Matters

Who Completes and Reviews a QA Questionnaire

Distribution and final sign-off are typically routed to persons with delegated authority; retention requirements depend on industry and applicable law.

  • Quality Manager: Designs questionnaire, assigns sections, and reviews aggregate results for trends and corrective actions.
  • Supplier / Vendor: Completes sections on processes, materials, and certifications when qualifying or requalifying vendors.
  • Internal Auditor: Uses questionnaire responses as evidence during scheduled or forensic audits to verify control effectiveness.

Core Sections to Include in a Professional QA Questionnaire

A complete QA Questionnaire groups items into logical sections so reviewers can assess compliance, root cause, and corrective action. Organize the form to match your quality management or supplier qualification workflow.

Process Details

Describe the process steps, controls, and responsible personnel so reviewers can map responses to operational reality and identify control gaps.

Product / Service Data

Capture product identifiers, lot/batch numbers, specifications, and inspection results to link answers to tangible deliverables and traceability records.

Compliance Checklist

List specific regulatory or contractual clauses and require explicit Yes/No evidence and attachments where noncompliance or exceptions exist.

Nonconformance & CAPA

Record observed defects, severity, root-cause analysis, corrective actions, owners, and target completion dates to drive remediation.

Attachments & Evidence

Allow scanned reports, test certificates, photos, and logs to be attached with clear naming conventions and version control.

Signatures & Audit Trail

Include signer identity, role, date/time, and an immutable audit log for accountability and evidentiary value in audits or legal reviews.

Essential Fields and Required Data Elements

Form Title: Quality Assurance Questionnaire
Entity Name: Full legal name
Product ID: SKU or lot number
Inspection Date: MM/DD/YYYY
Reviewer: Name and role
Signatory: Authorized signer

Step-by-Step: Completing a QA Questionnaire

Follow a consistent sequence to reduce errors, collect evidence, and ensure timely review and closure of findings.

  • 01
    Prepare: Gather process documents, specs, and prior reports before starting.
  • 02
    Complete Fields: Answer each question fully and attach required evidence.
  • 03
    Review: Have a second party verify responses and attachments.
  • 04
    Sign & Submit: Authorized person signs; form routed to quality owner.

Configuring the Questionnaire in an Online Workflow

Set up logical routing, conditional fields, and access controls so responses flow to the right reviewers automatically.

Field Configuration
Conditional Sections Show only when specific answers require follow-up
Reviewer Assignment Route by product line or region
Attachment Rules Require PDF or image evidence for key items
Access Control Limit edit rights to named roles

Where to Send or File the Completed Questionnaire

Decide submission destinations to support storage, auditability, and integration with downstream systems.

  • Quality Management System: Upload signed copy to QMS repository for retention and audit reference.
  • Supplier Folder: Attach to supplier record in ERP or vendor management system.
  • Internal Audit Team: Route flagged responses to auditors for follow-up or verification.
  • Regulatory Submission: When required, file supporting evidence with regulatory reporting packages.

Digital Sharing, Signing, and File Formats

Store signed copies in a secure content repository with access controls and preserved audit metadata to support compliance and forensic review.

  • Accepted Formats: PDF, DOCX, JPEG, PNG, and CSV for structured exports
  • Integrations: Connectors to Salesforce, Microsoft 365, Google Workspace, NetSuite, Box, and AWS support routing
  • Authentication: Email, SMS code, or stronger identity checks where required

Timelines, Review Deadlines, and Processing Expectations

Define clear timing rules for completion, review, and corrective-action closure so stakeholders meet audit and operational requirements.

Initial Completion:

Complete questionnaire within 3 business days of inspection or request

Reviewer Response:

Reviewer to respond within 5 business days with acceptance or findings

Corrective Action:

Root cause and CAPA plan due within 15 calendar days

Verification:

Verification of corrective action within 30 calendar days

Audit Retention Trigger:

Signed record retained per retention policy after closure

Common Mistakes to Avoid When Preparing the Questionnaire

  • Incomplete evidence: attaching summaries instead of original test reports creates gaps that auditors will flag and may require rework and delays.
  • Inconsistent identifiers: using different product or lot numbers across fields prevents traceability and complicates root-cause analysis.
  • Ambiguous answers: selecting 'Yes' without clarifying notes or attachments leads reviewers to assume nonconformance or demand follow-up.
  • Unauthorized sign-off: allowing individuals without delegated authority to sign can invalidate the record for supplier qualification or vendor payment.

Risks and Consequences of Incorrect or Missing Information

Operational Delay: Shipment holds
Regulatory Action: Fines or remediation
Contract Liability: Breach claims
Financial Loss: Rework or recalls
Audit Findings: Escalation to management
Data Breach: PHI exposure risk

eSignature Pricing and Feature Snapshot for Completing QA Questionnaires

Common vendor criteria for signing and managing QA Questionnaires include starting price, trial availability, bulk-send capability, audit trail, HIPAA support, and envelope limits. signNow is listed first for comparison.

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 free trial, no credit card Varies by vendor Varies by vendor Varies by vendor Varies by vendor
Bulk Send Available (Business Premium) Available on business plans Available Available Limited
Audit Trail Yes Yes Yes Yes Yes
Envelope Cap No envelope cap 100 envelopes/user/year Varies by plan Varies by plan Varies by plan

Frequently Asked Questions About the Quality Assurance Questionnaire

Answers to typical questions covering legal validity, e-signing, evidence, and correction workflows to help practitioners avoid common compliance issues.


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