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Operations & Quality · Quality Systems

Build the system. Train the team. Prepare for the audit.

SharpSigma helps manufacturers implement and strengthen quality-management systems, prepare for certification and process audits, build core quality documents, close gaps and train teams to use the system in daily operations.

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01 · Certification readiness

IATF 16949 & ISO 9001 readiness.

SharpSigma supports implementation and certification readiness; certification itself is performed by an accredited certification body.

  • IATF 16949:2016: gap assessment, QMS implementation, process ownership, required procedures, internal-audit readiness, management-review preparation and corrective-action closure.
  • ISO 9001:2015: QMS design or upgrade, process mapping, documented information, internal audits, management review and certification-readiness support.
  • Evidence planning, action tracking and closure against the applicable requirement.
  • Integration of quality-system requirements into actual engineering, supplier, manufacturing and operations workflows.
IMPORTANT DISTINCTION

Readiness support—not certificate issuance.

SharpSigma can help build, implement, assess and improve the management system and prepare the organization for external certification audits. SharpSigma does not represent itself as the certification body unless separately and explicitly stated.

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02 · Process audit readiness

VDA 6.3 preparation and gap closure.

Prepare processes, evidence and teams for customer or internal process-audit expectations using structured gap assessment and action closure.

ASSESS

Process-element review

Review applicable VDA 6.3 process elements, evidence, interfaces, responsibilities and operating controls.

CLOSE

Gap & action management

Convert findings into owned actions, due dates, objective evidence and closure verification.

PREPARE

Audit readiness

Prepare process owners and operating teams to demonstrate the system through records, controls and actual execution.

03 · Core quality tools

Create the documents—and make them usable.

SharpSigma can create, facilitate, review, restructure and align the quality-planning documents that connect product risk to manufacturing control.

FMEA

DFMEA & PFMEA

Creation, facilitation, risk review, linkage to lessons learned and updates as design or process conditions change.

CONTROL

Control Plans

Creation and alignment to PFMEA, product/process characteristics, reaction plans, inspection and process controls.

LAUNCH

APQP & PPAP

Planning, gate reviews, evidence tracking, submission preparation, readiness review and issue closure.

MEASUREMENT

MSA & SPC

Gauge R&R / measurement-system planning, control-chart strategy, process capability and Cp/Cpk/Pp/Ppk interpretation.

PROBLEM SOLVING

8D, RCA & corrective action

Containment, root-cause logic, corrective-action development, effectiveness verification and recurrence prevention.

AUDIT

Internal & supplier audits

System/process audits, supplier assessments, finding management, action follow-up and readiness reviews.

04 · Training

Train the team to run the system.

Training can be delivered as focused workshops, document-development sessions or role-based working sessions tied to the organization’s real processes and examples.

  • IATF 16949 / ISO 9001 awareness and implementation
  • VDA 6.3 process-audit readiness
  • DFMEA / PFMEA and Control Plan
  • APQP and PPAP
  • SPC and process capability
  • MSA and Gauge R&R
  • 8D, root cause and corrective action
  • Internal-audit and supplier-audit preparation
TYPICAL OUTPUTS

Evidence you can use.

Gap assessment, implementation plan, procedures/process maps, audit checklist, internal-audit findings, FMEA, Control Plan, APQP/PPAP tracker, training material, action log and readiness review—defined to the actual scope.

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Quality systems

Preparing for certification, an audit, or a stronger operating system?

Start with the standard, customer requirement, current gap or quality-tool problem. SharpSigma can define the readiness path and the evidence needed to close it.

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