By Paul K. Mignon
Auditing suppliers is different. Auditing suppliers is not and should not be a regulatory inspection by the customer. Auditing suppliers should not be an exercise in filling out a questionnaire together, though that can be helpful in several ways. A supplier audit should be relational, not transactional.
The auditor should also be able to answer the following questions:
Can I understand your systems? Can I understand your quality management system; your inventory system; your laboratory system; your manufacturing management system? Does it make sense? Can you describe it or better show me simply with diagrams, flow charts, or a brief written report?
Can you show me the money? Can you provide the evidence, the proof that your systems work?
Do you have a way to improve processes, systems, and your current way of doing business? Or is this the way you’ve done it for generations?
Are you clear about discussing your processes? Are you transparent? What an auditor wants to know should be clearly contained in the audit objectives of the audit plan.
How I find out what I want to know is another question and depends on the circumstance. Sometimes a standard checklist for that industry is a place to start, other times an audit team might review the key GMP systems one at a time: organization and personnel, building, facility and equipment, control of incoming materials and labels, production process controls, record keeping, warehousing, laboratory, supplier control, recalls and complaint handling, and, increasingly, safety/risk management.
Other times certain key areas for a manufacturing operation are critical, such as a USP water system, a company’s formulation process, how products are transferred in from one facility to another, or, in the case of a food operation, the effectiveness of their pest control program. In all cases, an auditor is looking to describe the processes as he/she sees them, and how they are described. Understanding the overall operation is invaluable for working on issues as they come up later and quickly answers a lot of questions for upper management.
How we achieve the audit objectives is also part of the assessment.
I say “we” because in an audit it takes two to tango. In the audit opening meeting the audit objectives are laid out and both the auditor and auditee are able to give a vision of what the successful audit will look like. Full cooperation is key. The audit opening meeting is great place for both parties to model and set the tone for the rest of the audit.
Some of the key points I make are:
- If I think there might be a finding, I’ll let the auditee know of the possibility. The auditee will know of findings beforehand and have a chance to provide more information or an explanation.
- The auditee will be able to review the draft audit report and the closing meeting comments for inaccuracies.
- The auditor is not here to scratch out findings for their own sake. The purpose is to fulfill the objectives of the audit, so the customer (my representative) has a good understanding of the processes and strengths and weaknesses of the operation.
The opening meeting, like the audit itself, may be awkward at first but by the end it should not feel like a trip to the dentist.
Positive indicators are a good flow of requested information and a good technical discussion of all affected systems. A sense of productivity should be reinforced by the auditor if things are on track.
Audit reporting/audit close-out/conflict
The use of emotional intelligence can be an important part of every auditor’s development. Recognizing the different types of conflict and how to diffuse them is part of auditing. Conflict comes in many shapes and sizes; it isn’t mentioned much in auditing education.
An example: A supplier may disagree with the whole concept of what you’re trying to do and sees no value in it. You can plow ahead and see how much information you can get or avoid conflict altogether and call the client immediately and lay out the kind of objections you are getting.
This scenario is infrequent and is usually pre-empted by planning meetings and remote auditing prior to on-site auditing. Another source of conflict will be the type of requests you make, which usually can be worked out. The last source of conflict will be findings. Just the fact of findings being discovered can be an offense to a supplier. Response to any of these can also tell a lot about the auditor and the supplier. Successfully maneuvering these issues on-site will forecast your future relationship. In many organizations the auditor will serve several roles, only one of which is auditing. The auditor’s main role may be supplier engineering, which includes specification development and technical problem solving. Other common roles are in quality assurance handling complaints, investigations, FSVP programs, and regulatory support. So, you might see an auditor during a product transfer, complaint, or initiation of a new product in another role. And they might even surprise you with a “good catch” or by solving a problem for you.
Finally, great credentials to pursue in this area are the ASQ Certified Food Safety and Quality Auditor (CFSQA) certification, ASQ Certified Pharmaceutical GMP Professional (CPGP) certification, and membership in ASQ’s Food, Drugs and Cosmetics division.
About the author
Paul K. Mignon is a senior QA auditor for Central Garden & Pet in Council Bluffs, Iowa. He performs primary and secondary audits, equipment, and process validation studies and is the site PCQI. He works in three product sectors: animal supplements/food, animal drug, and the insecticide business. He is the author of the “Animal Food” chapter in The Certified Food Safety and Quality Auditor Handbook, edited by Steve Wilson. He is an active member in ASQ’s Food, Drug and Cosmetic division and with ASTM. He is a PCQI lead trainer and an Exemplar Global principal auditor for food safety management systems.