Feature Article : Preparation & Tips for Successful Factory Audits
To help ensure that potential or existing suppliers deliver high-quality products, operate efficiently, and support continuous improvement, process surveys and factory audits are performed.
From supplier capability and qualification to process control and quality system audits, Pro QC offers a wide range of options. More specific audits incorporate standards such as the ISO series, TS 16949 specifications for the automotive industry, social accountability and sustainability, C-TPAT for security, GMP, AS 9100 for aerospace and many others. Requirements for audits do vary based on a number of factors. Two of our commonly requested general system audits include:
Supplier Capability & Qualification – Auditors survey potential suppliers and provide feedback regarding general operations, quality systems, qualifications and capabilities. This critical information aids in determining if the supplier is a viable source and potential partner.
Supplier Process Control & Quality System – Auditors evaluate all manufacturing process control systems for existing or new suppliers. Audits cover several areas, including evaluations of management, quality control methods, non-conforming materials, production, corrective action and inspection and test equipment.
In general, there are four questions considered to be critical to the audit process:
1) Are controls defined? 2) Are controls applied? 3) Do controls really work? 4) Will controls last?
For additional insight, we reached out to two of Pro QC’s supervisors to identify recommendations that ensure audits performed provide maximum value for all parties.
Consistent advice received maintains that preparation for an audit is a necessary component for success. Jean Champlain, Pro QC’s Supplier Development Manager in China, believes that “preparation for a factory audit can be broken down by responsibilities of the client (buyer), supplier (factory) and third party (Pro QC). Communication and documentation are key actions that increase the likelihood objectives are met.”
Champlain expands on this idea by providing the following outline of responsibilities and advice for each role identified:
The Client (Buyer):
* Informs the supplier to let them know an audit will be scheduled and provides additional contact details as available. Considers the length of time requested by the supplier, in addition to any initial hesitations noted. It is not considered appropriate to surprise a supplier with a visit to perform an audit. Audits should be expected to start and end at a predetermined time.
* Evaluates the expectations of the audit and relevant necessary components that should be incorporated into an on-site checklist or other evaluation tool.
The Supplier (Factory):
* Informs related internal people regarding the scope, agenda and contents of the upcoming audit. Educates management and staff members on what to expect during the audit.
* Completes and submits the Supplier Profile and Booking Form so the auditor can review preliminary information and the office can schedule accordingly.
* Keeps quality records and logs up-to-date and easily accessible. This usually includes current procedures, notification/distribution logs, inspection/audit records, CARs, FMEAs, DHFs, batch records, personnel records, etc.
* Ensures key members are available during the audit. . Pro QC International (3PQ Auditor):
* Works with the client to understand their expectations and the product and specific standard(s) involved.
* Selects an auditor best suited to the requirements noted and provides him/her with necessary training and recommendations to follow.
* Provides an audit notification letter along with an agenda of the audit, the Booking Form for scheduling and the Supplier Profile to the supplier to inform them of the audit activities so they can inform and prepare their internal attendees as noted previously.
* Selects a suitable audit checklist or develops a customized one if necessary.
Aside from checklists as a useful auditing tool, Laurie Meehan recently published an article relating to the Use and Misuse of Audit Checklists. In the article, she identifies a few key advantages that are worth mentioning:
“Items on an auditor’s checklist are likely to be aligned with regulations or a specific report format, or both. This makes verifying compliance and preparing the final deliverable easier and more systematic.”
“Checklists help with memory retention so details to be verified are not overlooked.”
“Checklists can promote consistency across the auditing program so different auditors will follow similar procedures when qualifying vendors and conducting QA audits.”
For additional insight, we also spoke with Eric Morgan, Pro QC’s Technical Supervisor in the United States, for an inside perspective as an auditor. When we asked Eric what he does to prepare for conducting an audit, he advises that, “determining the scope and objectives is a critical starting point that must be followed up by a review of the standards to be audited against and the procedures and reference documents should be incorporated into the research preparation.” Additionally, he carefully reviews any earlier CARs or PARs that have been issued or implemented to compare against regulatory standards, impacted areas and gage the overall efficacy of the action or change.
During training, Eric advises new auditors that “staying neutral and keeping the interview positive” is important. In addition, auditors must be sure to ask for copies of supporting documentation and provide detailed photos to help supply adequate evidence to support observations or claims. He also noted that asking questions and observing if there is evidence to support that the process inputs equal the desired outcomes are key. Eric suggests auditors “always place themselves in the position of the person who will be collecting the information.”
Finally, Eric summarizes the essence of an audit as well by adding “audits are meant to provide a value added activity for the auditee and the shareholders requesting the audit. While the audit provides shareholders with qualitative observations from an independent perspective, the audit should also present the auditee with an opportunity to realize their potential and make improvements as necessary. Properly conducted audits will assist with better alignment of activities to the priorities, needs and wants of the customer; also known as the voice of the customer (VOC). Subsequently, the vendor can take advantage of the initiative by developing systems that will enable them to eliminate risk, increase profit and/or reduce waste.”
Mary Chris Easterly expands on the perception of the auditor and value of an audit in a recent article included in ASQ’s September 2014 Audit Report, in which she notes that, “ideally, an organization always operates in a state of control and compliance with requirements. If there is a lapse in control or compliance, the organization’s systems should be able to quickly detect the exception and address it to prevent recurrence. Audits should be valued, because an audit is an opportunity to find any missing links or potential issues.’
For more information regarding specific audits, the process in general, or to schedule an on-site visit, please contact us at email@example.com.
Additional related information we have published online includes: