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Be Prepared for Your Next Quality Audit

Posted by Ellen McKewen

Very few people like to hear that they’re being audited, particularly by an outside organization. However, handling the occasional audit doesn’t have to be a stressful experience for manufacturers.

One of the keys to handling an audit is knowing what the quality auditor is looking for, so that you can better accommodate the audit and keep operations running smoothly. With this in mind, here is a list of the things that auditors most commonly look for when performing an audit:

General Planning

When auditors are assessing your business, one of the biggest things that they’re looking for is some kind of indication that your business processes are planned out and have objectives or standards that they should perform to.

Auditors need to know what controls are in place to ensure that your production process conforms to both your company’s internal requirements and the requirements of external organizations.

Here, you’ll want to pay special attention to the communication or link between related processes and departments. The transition from one process to the next and the communication between departments is usually the weakest link in any company’s planning.

Manufacturing_Document_ControlDocument and Record Control

Every document and record that your company uses which might affect your ability to provide service to your customers or meet client quality standards, delivery, safety, environmental, legal, and other special requirements should be tightly controlled, yet readily retrievable.

Records and documents that an auditor will check include:

  • Training Documents. To assess the effectiveness of employee training.
  • Onboarding Processes. To make sure new hires are receiving the training they need to be considered competent for their work.
  • Emergency Drill and Safety Meeting Records. To verify that employees know their emergency procedures.
  • Customer Contracts and Purchase Orders. To ensure that legal and customer requirements are being fulfilled.
  • Design and Development Records. To see if your design and development efforts follow a reliable plan to ensure that the final product meets all function and performance requirements.
  • Purchase Documents. To establish if your company has methods in place to approve suppliers/vendors that meet the Quality requirements that apply to them.
  • Quality Control Documents. To find evidence that you inspect your products prior to delivery to ensure that it meets customer requirements.

Records need to be placed in predetermined locations, and kept intact and readable for as long as your required retention period specifies.

Management Alignment to the Quality Management System

Auditors typically examine management reviews of the QualityManagement system to determine the level of commitment that management within the company has to the current quality system in place.

During their examination, auditors will check for evidence that management provides adequate resources to employees. They also look for proof that thorough communication of the importance of the system to employees took place that meet customer and legal requirements.

Auditors will attempt to determine if management team members are making satisfactory assessments of a process’ risk to the environment and to health and safety, as well as the process’ ability to meet customer requirements. A review of actions taken to mitigate risk will also be an important factor in the audit.

Maintenance and Housekeeping

Aside from checking your processes and paperwork, an auditor will need to make a manual inspection of your production facility.

Items that an auditor will often check for include:

  • Adherence to housekeeping standards (facilities are reasonably clean & clear of clutter)
  • Safe working conditions (walkways have intact railing, no open vats of exposed chemicals not in use, etc.)
  • Environmental hazards (waste and emissions are being kept to a minimum, waste is being disposed of properly, etc.)
  • Equipment is in good working order (regular maintenance has been performed, no signs of damage that could compromise operation)
  • Ambient environmental conditions within and around the production facility that could affect production standards (humidity, temperature, and the like)

Your Production Process

Manufacturing_Process

An auditor will want to review your actual production process to verify that not only is it planned out according to your documentation, but that it follows your plan and meets the various customer and legal requirements that apply to your manufacturing process.

Furthermore, an auditor will make sure that products are traceable to a manufacturing lot number if required by the customer, and customer-owned property is protected.

Your methods for monitoring and measuring your production process should be well-documented, along with your Key Performance Indicators (KPIs) that you use to set performance targets.

Customer Satisfaction

Auditors will check to make sure that you have a system in place to collect “customer perception data,” such as a survey, that allows you to get feedback from customers whether positive or negative. An auditor will also check to see if that information has been acted upon to improve customer satisfaction.

Customer complaints should be thoroughly documented, as well as their responses, or the management decision to not respond to a given complaint.

Internal Audits

Your company should have records of internal audits for your processes, training, personnel, equipment, etc. for outside auditors to review.

The auditor will assess your internal audit process for effectiveness, as well as the qualifications of your internal audit personnel, so complete records are a must.

How You Deal with Nonconforming Products

An auditor will want to review the process your company has in place to deal with products that don’t meet your customer’s performance standards. They will need to assess that any nonconforming product is identified and controlled so as not to be sent to the customer without prior consent.

Evidence of Continuous Improvement

Constant refinement of processes and procedures is a key part of maintaining a competitive edge in manufacturing. Auditors will check your records for corrective actions that you took in response to an error, as well as what preventative measures you put into place to stop the same errors from being repeated.

The auditor will need to see that your company investigated the error, determined the root cause, and took measures to prevent further errors. You should have documented evidence that your corrective actions were effective.

The Big Three

In short, auditors are looking to see that you:

  1. Say what you will do
  2. Do what you say
  3. Can prove it

Records and interviews will help you create the objective evidence that an auditor will need to make sure that your business conforms to its internal requirements, the requirements of customers, and its legal obligations.

Audits are more than just a legal obligation, they’re a chance to identify areas for improvement in your manufacturing process and verify that your efforts at improving are proceeding as planned.

Our thanks to Jay Wiessner, Quality Systems Consultant, for his contribution to this blog post.  

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Topics: Quality

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