Blog entries

Do Your Corrective Actions Meet Smithers' Expectations?

SQA Quality Auditor — Mon, 07 May 2012 16:00:20 +0100

Clients have commented that recent changes to Smithers' Corrective Action process have helped them create a more robust process for their organizations and develop better nonconformance responses and system improvements.

To help you continue to improve your Corrective Action system, we created a new document titled, SQA's Corrective Action Expectations.

Our auditors will be verifying submitted Corrective Actions against these outlined expectations and will identify when the resp...

How to Avoid a Common Weakness in Internal ISO Audits

SQA Quality Auditor — Thu, 19 Jan 2012 17:08:01 +0100

By Helmut Jilling, SQA Auditor

There is a common weakness in internal audits. The old element-based checklist method was easy to use - just a series of checklist questions and answers. But over time, the checksheets became less effective. Audits focused on the same few questions, again and again. They ceased to uncover other issues and improvements.

The ISO Process Approach is much better. It follows audit trails through the process and into related linked processes, but it is m...

SQA Joins Smithers Rapra at Upcoming Conferences

SQA Quality Auditor — Tue, 11 Oct 2011 11:58:58 +0100

Smithers expertise is often recognized at national conferences. Representatives from Smithers Quality Assessments have joined with another Smithers business group, Smithers Rapra, at two major upcoming industry conferences.

Smithers Rapra is a global leader in rubber, plastics, polymer and composites testing and consulting services focused mainly on the tire, industrial, transportation, consumer and medical industries. It is one of the five business groups under the Smithe...

New Online Tools for Root Cause Analysis Available

SQA Quality Auditor — Thu, 25 Aug 2011 13:31:30 +0100

We recently announced that as of August 22, 2011, any corrective actions resulting from a non-conformance identified during an audit should be accompanied by a root cause analysis as part of the corrective action submittal.

Read our August 2011 Newsletter to learn why.

To assist you with this new requirement, we have developed a 5-Why tool which can be used as a simple root cause methodology, or you can submit your own version.

Access our 5-Why Tool.

For ...

4 Things to Look for in a Quality Auditor

SQA Quality Auditor — Mon, 15 Aug 2011 18:07:17 +0100

In late July, Smithers Quality Assessments (SQA) held an Auditor Training conference in Akron, OH near our corporate headquarters. Our goal is to make sure our auditors are up-to-date on the latest information regarding the business management systems for which we are accredited, including ISO 9001, AS9100, ISO/TS 16949, ISO 13485 and ISO 14001.

There are several quality and environmental business management systems certification companies out there. We all likely use different ...

AS9100 Rev. C Deadline Quickly Approaching!

SQA Quality Auditor — Wed, 29 Jun 2011 10:01:51 +0100

AS91XX:2009: Deadline Almost Here!

July 1 is quickly approaching. Remember all AS9100 audits must be conducted to Rev. C utilizing the AS9101D requirements for the audit and reporting process. Your auditor will notify you 45-60 days prior to your audit to request the following information in order to better plan your assessment:

Scope of audit including complexity
...

AS9100 Certification Has Business Benefits and Helps Employees Understand Role in Quality

SQA Quality Auditor — Tue, 14 Jun 2011 17:38:05 +0100

Certification to the AS9100 Standard has many obvious benefits, including access to the best practices of the aerospace industry, and clearly demonstrating your company’s commitment to quality products and services to your customers and prospects.

What you may not realize is that once you are AS certified, your company name is entered into the OASIS database. This database is a major resource many large OEMs use to find new suppliers with expertise in various areas. It can be a ...

Think Beyond "Human Error" in Corrective Action Requests in Quality Management Systems

SQA Quality Auditor — Wed, 25 May 2011 13:33:45 +0100

A key aspect of an effective and acceptable response to a Corrective Action Request (CAR) in a Quality Management System is the identification and statement of “Cause.” A CAR is a procedure used in response to a nonconforming product, service or process.

The expectation from ISO guidelines is that the organization will investigate and resolve the process in their quality management system that:

did not exist,
failed, or
was weak to the poin...

SQA Experts on Panel for March 8 "Transitioning to AS9100 Rev. C" Workshop

SQA Quality Auditor — Wed, 02 Mar 2011 17:53:49 +0100

Representatives from Smithers Quality Assessments will be on hand to answer questions and provide insight into the transition to AS9100 Rev. C. in a free March 8 Workshop sponsored by Purdue Manufacturing Extension Partnership.

Click here for more information.

Through a mixture of presentations and discussions, participants will:

Discover that as of July 1, 2011 ALL AS9100 audits will be to the new standard
Learn the differences between AS9100 Rev. B and Rev. C
Experienc...

Detailed Documentation and Research Can Streamline ISO 13485 Audits

Ed — Thu, 17 Feb 2011 16:20:52 +0100

As an auditor for the ISO 13485:2003 standard for the design, manufacturing and distribution of Medical Devices, I can attest to the benefits of preparing for and documenting audit information in detail. Through the implementation of ISO 13485, companies increase the probability of making safe and effective medical devices, meeting regulatory requirements, and ultimately meeting customer expectations. Many times a client may not realize that a comprehensive internal audit needs to be conducte...

Expand Your Definition of a Quality Management System to Include All Business Functions

Tracy — Tue, 01 Feb 2011 05:00:00 +0100

As organizations enter compliance with AS9100 C, there are many steps you can take to streamline the internal audit and certification process. These include defining your process so it encompasses all business areas; understanding the roles and responsibilities of your management team in the certification process; and viewing the internal auditing process as a business asset, not a function, and staffing it appropriately.

A clear and effective development plan for the life of your Qual...