Quality Management

In order to meet both customers and your own internal expectations, each organization must have a strong quality management system and documents. The documented Process Management System must be clear in describing the controls along each step of the process, as well as identify and solve problems. When an effective quality system and documents are in place, potential consumers and stakeholders will be confident that the goods and/or services you offer meet or exceed their expectations.

We will review your current Quality Management System and documents and provide a “Gap Analysis” report highlighting areas for improvement. Once the Gap Analysis has been reviewed and agreed upon, procedure modifications will be performed along with any needed training.

Areas of Emphasis from ISO 9001 / IATF 16949 include:

• Scope
• General Quality System Requirements
• Management Responsibility
• Resource Management
• Production Realization
• Measurement, Analysis, and Improvement
• Performance Evaluation

Is your organization in need of Quality Training? Many organizations believe that quality is something everyone will pick up and understand over time without realizing that proper training is crucial. The better your organization and employees are trained, the better your organization will perform. PEC offers training in all aspects of Quality including but not limited to:

• Quality Management Optimization and Implementation
• Root Cause Analysis
• Error Proofing
• Internal Audits
• Process Failure Modes Analysis
• Manufacturing Control Plans
• Work Instructions

Root Cause Analysis (RCA) is the systematic approach of identifying the baseline cause of an issue that if fixed will prevent the issue from happening again. Many organizations stop short of identifying the true root cause and subsequently have the same failures over and over again causing lost time, money, and customer confidence.

Whether you are looking for training to refine your organizations RCA skills or if you are looking to have a new system implemented, our experts can help by training on or implementing the following:

• Extent of Condition
• Problem Statement Identification and Development
• Problem Analysis (using the most appropriate tools)
• Corrective Action Identification
• Read Across
• Effectiveness Evaluation

The definition of an error is a human mistake. Is your process protected from human mistakes and have you done everything to protect both your products and your people from errors? One of the more recent yet crucial requirements of an ISO 9001/IATF 16949 certified quality management system is a functioning Error Proofing system.

Whether you need an Error Proofing system implemented or your current Error Proofing system optimized, our quality experts have the knowledge and experience to develop and implement a world-class system.

The purpose of an Internal Audits Program is to make sure that your organization is following the quality management plan as defined. Many organizations will develop a robust quality management plan but over time will deviate from this plan. Internal Audits highlight deviations from the defined quality management plan and help the organization identify and correct issues as soon as possible.

Our quality experts can implement and perform your internal audits, or we can take a look at your current system and recommend and implement improvements.

Are you currently looking to get your company ISO 9001 or IATF 16949 certified or preparing for your upcoming certification Audit? The key to passing an audit or achieving ISO/IATF certification is proper preparation. PEC has a certified Lead External Auditor on staff to educate you on the current requirements and what to expect during an audit. PEC will guide you through every subsequent phase of audit preparation.

Our experienced consultants will review your current documents and procedures and provide a “Gap Analysis” highlighting areas for improvement. Once the Gap Analysis is reviewed with your organization, a detailed mitigation plan will be developed that addresses your organization’s specific needs. Once the mitigation plan is approved, PEC consultants will help your organization to implement the agreed-upon plan.

The key to mitigating audit findings is a thorough understanding of the regulations as well as a thorough understanding of Quality, Engineering, and Operations. Too many times, organizations establish a mitigation plan without truly understanding the regulations or the intent of the regulations. PEC has a certified Lead External Auditor on staff that will review your findings for accuracy and helps your organization understand any deficiencies.

In collaboration with your organization, we help you to author an appropriate response to the auditing organization. Once the initial response is submitted, PEC will help your organization develop and implement a mitigation plan with timelines that are reviewed periodically.

PEC has successfully guided organizations in mitigating multiple major audit findings by reviewing and rewriting processes, developing a mitigation plan, and leading the implementation of the mitigation plan. Each organization we have consulted experienced zero findings in the subsequent audits. Let our experts assist you in mitigating your audit findings and achieving or maintaining your certifications.