Our Consulting services provide technical leadership and support in pre-, mid-, and post-production environments at any point in the global supply chain.

Our seasoned, specialized quality engineers are typically deployed as part of a larger managed program. This ensures full alignment with client strategy and goals for supplier quality – not just the activity at hand. We can provide full Quality Engineering services through the entire manufacturing life cycle. Capabilities include:

Pre-production

DHF Files- Remediation

BSI / Dekra Checklist (SME Review)

Labeling MDR Gap Analysis

Biocompatibility/Stability Evaluation

Regulatory Consultants

Reliability Engineering

Risk Management

PFMEA

First Article Inspection program development

Production

CAPA

IQ/PQ/OQ

Process Control Validation

Measurement Systems Analysis

In-process and Final Inspection program development

Production Line Improvement

Post-production

Dock-to-Stock program development

Supplier Inspection Training

Root Cause Analysis

Quality- and Production-related gap analysis

Key Benefits

located in hundreds of cities throughout the US and in over 50 industrialized foreign countries

industry experts to suit your needs

short- or long-term availability

global presence, local position

fully supported by TSG’s Engineering, IT, and administrative program management resources

Getting Started

We typically begin a long and successful client relationship by satisfying a single, challenging requirement for expert Engineering support. Feel free to talk to a Sales Representative or Project Manager about your needs, without obligation. All we need to get started is your:

Specific technical requirements

Geographic area and time frames

A purchase order or signed contract

… and TSGs service team will provide you with a variety of suitable support options in the shortest possible time.

Our Source Inspection services are essential in helping you manage fluctuating activity across your supply chain.

For our aerospace, defense, and medical device clients, source inspections are essential to maintaining regulatory compliance, avoiding counterfeit parts and running a leaner, more profitable business. With our management process, expertise and coverage, and your inspection parameters and direction, you can extend your quality organization to anywhere in the world within 24 hours. This allows you to slash your travel budget, keep your experts at home, and be represented by local individuals who are both a technical and a cultural fit.

Reach Further. See More. Spend Less.

Through TSG you can accomplish all your First Article, In-Process, Final or Containment inspections without having to worry about expanding or contracting your workforce. We can both reduce your costs and achieve better results.

Our Quality Audits can help you in a crunch, or free up your valuable resources to focus on strategic supply relationships.

In any case, our approach is structured for the flexibility and consistency you need to execute a value-adding audit program. Our auditors are specialists in their fields, providing you subject matter expertise, as well a focus in areas you deem as critical. TSG’s “Audits With Teeth” approach ensures that every audit we perform for you has specific technical, quality, and business goals. Their close proximity to your suppliers anywhere in the world also ensures that cultural issues are put aside, so emphasis may be placed on your first priority: the systems that create products that go into your supply chain.

Key Benefits

Superior Auditing Resources:

Thousands of Associates located close to your suppliers around the world

TSGs Auditors are high-caliber specialists that only require a subtle orientation to your procedures

Auditor performance is measured and monitored

TSG’s internal process ensures auditors are screened, qualified, and validated by TSG Audit management

You always have the option of first-approval of Auditors

Industry Focused:

TSG assigns industry experts depending on your requirements, e.g. AS 9100, ISO 9000, cGMP

Alternatively, we adapt to your proprietary approach or provide you with TSG’s comprehensive Audit Procedures

Getting Started

Some of our most successful Managed Audit Programs have begun with a single, typically challenging, audit requirement. Feel free to talk to a Program Manager or our Field Engineering Directors about your needs, without obligation. All we need to get started on your program is your:

Procedures, SOPs, Training material, Checklists, etc., in electronic format or otherwise (or TSG can provide these)

Suppliers to be audited, including commodity types, locations and time frames

A purchase order or signed contract

… and TSGs service team will direct all your auditing engagements to your satisfactory completion.

Managing supplier corrective and preventative actions (CAPAs) can be challenging and time consuming.

They require constant monitoring, follow-up, and review from several different stakeholders inside and outside your organization. Our proven process for taking supplier CAPAs from acknowledgement to evidence of effective closure has proven to be faster and less expensive than using precious in-house resources.

We manage corrective actions for numerous Fortune 500 companies around the world. Whether you provide TSG with pre-defined corrective actions or combine your corrective actions with our managed audit services, we will partner with your suppliers to ensure corrective actions are closed and measured for effectiveness.

Key Benefits:

TSG aligns our proven Corrective Action Management process to your business requirements.

Our CAPA review team comprises certified industry experts that are aligned with ISO, cGMP, etc.

TSG’s automated and personal follow-up provides fast closure.

TSG filters all your supplier responses first to provide you with a qualified output for your final review.

You have online, on-demand access to all CARs and supporting documentation, 24/7.

TSG’s automated system, STEPQ, alerts you when action is required.

Using STEPQ, you have real-time CAPA data to trend your supplier performance.

Get your suppliers up to speed without slowing you down.

Our Supplier Remediation helps you to develop suppliers to sustain your minimum level of acceptable requirements or regulatory standards. This is achieved through an initial assessment of selected suppliers, benchmarked to your custom needs or best practice standards, and subsequently remediating the observations and non-conformances discovered with close technical support.

Elevate Your Supply Base. Fast Track Your CAPA Process.

Our global team of quality professionals works hand-in-hand in a close partnership with you and your suppliers to establish and work towards manageable, achievable goals. Our team helps your suppliers implement systems that will improve and/or remediate systemic gaps in their Quality and Manufacturing Systems. Our tried-and-true process has helped clients across multiple industries achieve a stronger and more reliable supply base, and in the process it has helped their suppliers mature their own quality and manufacturing systems to become more sustainable partners.

TSGs Supplier Remediation Infrastructure

Global network of TSG Quality Engineers

Standard process to fast track closure of remediation findings

Standard process for developing suppliers into higher levels of compliance

Ready-to-use library with skeleton compliance system elements, e.g. Procedures, Work Instructions, Training

Full program team support, e.g. Management, Administration, Technical Review, Technical Translation

Automated Metrics to track, escalate (when required), and document progress

REMOTE ASSESSMENT

Offering comprehensive supplier review without having to be on-site, TSGs Remote Surveillance Assessment tool combines the qualitative aspects of secure, objective evidence gathering with the quantitative aspects of automated, tracked and scored supplier evaluation criteria.

Once an  program is underway, we manage all aspects of data collection and review with your chosen suppliers. We review supplier responses and either accept or request more information where needed. When supplier responses require more information, we work with them to provide a complete picture. RSAs are also scalable, from the acquisition and checking of basic supplier details, to a true remote assessment by a certified lead auditor. Part of the scoping process is to work with you to determine the right level of depth and oversight required.

RSAs, like all TSG-managed events, are available through our STEPQ website and can trigger corrective action (CAPA) and other related events– all of which can be viewed and controlled through your real-time activity dashboard or scheduled email alerts.

For Suppliers:

Easy user interface helps suppliers quickly complete their information. When editing, suppliers see sections, position, and requirements for each section.

If a supplier user attempts to submit an incomplete checklist, a reminder message appears, requesting a complete checklist.

For Clients:

Authorized users can check the status of the program in real-time. Where action is required, notifications will also be sent automatically via email.

When viewing the checklist, dynamic graphs can highlight overall results at a glance.

The supplier responses, objective evidence, score, and status are shown.

Any subsequent action (like a corrective action) appears as a ‘connected’ event, and follows its own process to closure (including separate supplier response).