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WCH PROFESSIONAL SERVICES, LLC
649 E. Green Street
2009-03 AUDIT #: Allentown, PA 18106
Phone: 570-350-9256 07/23/09 DATE:
www.wchservices.com
SAMPLE COMPANY
INTERNAL AUDIT
SCOPE: SAMPLE DIVISION
July 23, 2009
Prepared by: Sally E. Wilk
Management Consultant
WCH Professional Services, LLC
Email: swilk@wchservices.com
WCH PROFESSIONAL SERVICES, LLC We Can Help! Scope of Audit
The division included in the scope of this audit is the Sample Division.
ndThis audit is a 2 Party Audit which serves as an Internal Audit of Sample Company’s Quality Management
System.
The following elements of ISO 9001:2008 were addressed during this audit as they apply to the ISO 9001:2008
standard and Sample Company’s Quality Management System as defined in Sample Company’s Global
Operations Manual, the Sample Division’s Manufacturing Operations Manual and supporting documents: 4.1,
4.2.1, 4.2.3, 4.2.4, 5.1, 5.2, 5.3, 5.4, 5.5, 6.1, 6.2, 6.3, 6.4, 7.1, 7.4.2, 7.4.3, all of Section (including sub-sections)
7.5, 7.6, 8.1, 8.2.3, 8.2.4, 8.3, 8.4 and all of Section (including sub-sections) 8.5.
The audit was accomplished by reviewing the documents and records within the department and by interviewing
the department personnel. It is important to note that this audit represents a “window in time”.
The Internal Audit Schedule demonstrates that all ISO 9001:2008 elements will be audited during 2009. It is to
be used in conjunction with the completed “Internal Audit Checklist” provided with this report.
The following personnel were interviewed during this audit: Person A, Person B, Person C, Person D, Person E
and Person F.
Audit Summary
All of the necessary systems required by ISO 9001:2008 are well-defined. All appropriate ISO 9001:2008
requirements have been addressed by the Global Quality Systems Manual and the Departmental Operations and
Procedures Manuals. For more details, please refer to the “Positive QMS Implementation Aspects” shown
below. There were no Non-Compliances, three (3) Observations and three (3) Recommendations written during
this audit.
Positive QMS Implementation Aspects
• All measuring equipment was found to be calibrated and current.
• Hard copies of engineering drawings that were reviewed during the audit were found to be the latest
revision.
• People’s responsibilities have changed, but all of the auditees were aware of their new responsibilities
and seem to be performing them admirably, with the exception of Preventive Maintenance (reference
Observations for details.)
• Nonconforming Product and scrap are identified and segregated.
• Job Descriptions and Training Records are up to date.
• Corrective and Preventive Actions are being implemented and recorded. The Division Supervisor
indicated that the CA and PA process has proven to be a very useful tool when working with suppliers.
• The Sample Division is utilizing Lean Manufacturing methods to continual improve their operations.
WCH PROFESSIONAL SERVICES, LLC Page 2 of 4
Non-Compliances
There were no Non-compliances found during the audit. Non-compliances are written when one or more of the
following is true:
• Applicable requirements of the standard are not addressed in system documentation.
• There is a complete system breakdown.
• Unauthorized actions.
• Employees disregard process controls.
• Internal audits are not maintained.
• Obsolete or uncontrolled documents are used regularly.
Observations
There were three (3) Observations found during the audit. Observations are written when one or more of the
following is true:
• There is an observed temporary failure to meet the requirements of the standard.
• There is a failure in a few cases to follow documented processes or procedures.
• System documentation requires minor revisions or clarification.
• There are isolated system nonconformities that do not appear to represent a systemic problem.
Details of the Observations are described below:
Section 4.2.3 of ISO 9001:2008 requires that “documents required by the quality management system
shall be controlled . . . . A documented procedure shall be established to define the controls needed . . .to
ensure that changes and the current revision status of documents are identified, to ensure that relevant
versions of applicable documents are available at points of use.”
The Organization Chart in the Sample Division Operations Manual was updated on 5/11/09. Revision
History page shows 8/24/06.
Section 4.2.4 of ISO 9001:2008 requires records of Corrective and Preventive Action be kept.
The Sample Division is recording Corrective and Preventive Actions and is keeping records. These records
are not shown on the “Record Retention” page, Page 8 – dated 3/19/04, of the Division Operations Manual.
The Preventive Maintenance Sheets for the Cement Line and Paint Line indicate that PM is to be
performed weekly.
There are no records of Preventive Maintenance on either of these lines after May 2009.
WCH PROFESSIONAL SERVICES, LLC Page 3 of 4 Recommendations
Recommendations are simply suggestions that may quickly be addressed and may help to improve the
company’s QMS. There were three (3) Recommendations made during this audit.
Paint Inspection Sheets contain acceptance criteria / instructions. Due to continuous copying of sheets, the
criteria were not legible on the sheet used to record data on 07/23/09. Recommend using a fresh original to
make copies from in the future.
Carrier Chart posted in the Shipping Area should be updated. It currently lists Yellow Freight as a carrier.
Administration stated that Yellow Freight was replaced by UPS Freight approximately two months ago.
Also USF Holland changed their name to New Penn.
PI Tape for 24”-39” does not have Serial Number listed on the can. All other PI Tapes do. Recommend
showing Serial Number on the can.
WCH PROFESSIONAL SERVICES, LLC Page 4 of 4