Process Metrics
(Monitoring Quality Management System Processes)

• Input and output expectations
• Determine the sequence and interactions of the processes
• Determine and apply criteria and methods needed to ensure that both the control and operation of these processes are effective
• Determine resources needed, assign responsibility, address risk and opportunities
• Evaluate processes and implement any changes needed to ensure that these processes achieve intended results

What’s Inside AIAG / VDA’s FMEA First Edition?

• New Seven Step Process
• Structure and Function Analysis
• More detailed Failure Analysis
• Ranking (RPN) replaced with Risk analysis (Action Priority)
• more...

• Determine necessary competence of Staff / Contractors
• Ensure staff/contractors is competent
• Take appropriate steps (training…)
• Retain appropriate documented information
• Training Needs / Competency requirements matrix or equivalent – Who needs what?
• Records of competence

• Training Needs / Competency requirements matrix or equivalent – Who needs what?
• Records of competency
• Related to work instructions

COVID-19 Update from Michigan

• Richelle Kinzie, President – 616-240-9367, This email address is being protected from spambots. You need JavaScript enabled to view it.
• Dave Gawlak, VP of Sales & Marketing – 616-990-1036, This email address is being protected from spambots. You need JavaScript enabled to view it.
• Tom Droog, Technical Operations Manager, 616-813-2655, This email address is being protected from spambots. You need JavaScript enabled to view it.
• Melissa Smith, Quality Manager, 248-561-4013, This email address is being protected from spambots. You need JavaScript enabled to view it.
• Renae Bennett, Controller, 616-430-5351, This email address is being protected from spambots. You need JavaScript enabled to view it.
• Cynthia Redick, Processing Manager, 616-450-3511, This email address is being protected from spambots. You need JavaScript enabled to view it.

Internal Auditing During Pandemic

• FMEA
• SIPOC
• Turtle Diagrams

Keys to Performance

ASR auditors have found organizations going through a Stage 1 audit fail to audit their entire quality system fully.  There appears to be a misconception that a Stage 1 audit is merely a “gap” analysis or pre-assessment, and a full system audit is not necessary. 

A full system internal audit is part of the Stage 1 audit preparations. If not conducted by Stage 2, it becomes a nonconformance at the Stage 2.   (For an IATF audit, the lack of a full system audit could stop the Stage 1 audit, and the client would be deemed “Not Ready” which means they would have to repeat the Stage 1).

The purpose of a Stage 1 audit is to ensure the system is fully implemented, operational and appears to be effective in meeting not only the standard’s requirements but the organization’s internal objectives as well. A secondary purpose is to review any audit trails that surface and to identify other areas that could be nonconformances at Stage 2. 

Internal auditor competency issues continue to be a challenge for organizations whose quality or environmental system falls under the ISO banner.  ASR auditors are finding a lack of formal training of internal auditors. Organizations are responsible for ensuring their internal auditors know the standard they will audit, as well as knowledge of how to audit including the process approach to auditing as specified in the respective standard.

A strong internal audit program is a highly valuable tool for organizations to use as they drive their quality or business management system for continual improvement and performance.

ASR is available if your organization needs additional clarification of the internal audit process.

• FMEA
• SIPOC
• Turtle Diagrams

ASR Accreditation for ISO 45001:2018
June 2020
 

ANAB has granted ISO 45001:2018 (occupational safety & health) accreditation to ASR.

ANAB revised their new standard accreditation process to limit initial accreditation to only technical areas associated with the initial accreditation witness audit.  This means ASR can provide accredited ISO 45001 certification in a limited scope of technical areas.  These technical areas include:

Main Cluster: Mechanical

IAF Codes:

17b – limited to fabricated metal products

18 – Machinery and Equipment

19 – Electrical and Optical Equipment

22 – Other Transport Equipment

ASR will continue to add additional technical areas/IAF codes as requested by our clients.  Each new code expansion will require ANAB to witness ASR’s ISO 45001 auditors.

If you have questions or would like to participate in a witness audit to further expand our ISO 45001 accreditation certificate, contact This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it.

• NEW AIAG / VDA Failure Mode & Effective Analysis Course
• SIPOC (Supplier Inputs Process Outputs Customer) Course
• Turtle Diagrams

Audit Trails from Restarting Operations due to COVID-19
June 2020
 

As businesses and industry slowly restart, organizations are thinking about COVID-19 management and operation start-up, with a return to stable operations and communication of that restart plan to relevant interested parties/stakeholders.
 
Management of COVID-19 is key to the return of a safe work environment. Plans may include a strategy for virus prevention, reduction of potential exposure, and implementation of a reaction plan if the virus is detected within the organization and should cover both employees and visitors.
 
Once that’s in place, organizations should expect to show auditors how they handled the COVID-19 recess as a result of limited production or the complete stop and restart of operations.
 
For many, restarting the organization may include several items that could lead to a variety of audit trails at the next audit. For example, the auditor may ask about addressing workforce availability and whether refresher training was necessary for those who were laid off. Auditors may query material planners about the status of inventory on hand, the possibility of expired materials in the plant, supplier readiness, and supply chain capacity, including outsourced processes. Auditors may ask about customer orders and changes to forecasted requirements, delivery schedules, backorders, canceled orders, and work in progress. From an infrastructure perspective, auditors will be interested in tooling and equipment that may need some attention prior to start-up. Does production software need to be revalidated, and if so, how was that done? How were calibrated tools with expired dates, out of date software, or past due maintenance handled? How was the ongoing suitability of those items verified? Were first articles or first piece approvals required to prove that the manufacturing processes were still capable of producing parts to the applicable specifications? These are some, but not all, issues organizations are facing in their return to operations.
 
From a business planning and management system perspective, auditors will expect to see updates to an organization’s risks and opportunities documentation or contingency plans. Auditors will expect management review records to capture the implementation of COVID-based reactions and the risks/opportunities associated with the ramp-up plan to resume “normal” operations. Auditors will likely ask about objectives, how they may be impacted as a result of the shutdown, and what action plans are in place to mitigate any adverse effects.
 
The objective is to return to a safe and stable operation while utilizing the management system to control the outcome and monitor for effective results.
 

• NEW AIAG / VDA Failure Mode & Effective Analysis Course
• SIPOC (Supplier Inputs Process Outputs Customer) Course
• Turtle Diagrams