Medical Gas Self-Audits

Problems in your medical gas operations do not have to spell disaster.

Practically every FDA seizure action of which I am aware could have been avoided by performing periodic, thorough self-evaluations. In a nutshell, the FDA would rather you discover (and correct) a problem than they discover it. Diligence and prompt corrective action when needed is key to enjoying continued success in the medical gas business.

Oxygen TanksAlthough some FDA field personnel may offer suggestions or appear helpful in other ways, never forget that they are not extensions of your compliance program and they aren’t consultants. They are enforcement personnel whose primary function is to assess your compliance with Current Good Manufacturing Practices (CGMP).

It is also necessary to remember that past inspections are not indicative of future inspections or even of your current compliance status. Although impromptu pronouncements of new CGMP policy has eased the past couple of years, we will never escape the simple fact that inspectors are individuals, each with their own “pet” issues and ideas of what is important. It’s confusing and very frustrating to be cited for multiple violations when the last inspection yielded a clean slate and nothing has changed! Unfortunately, that’s just the way it is when compliance is such a subjective matter. Therefore, diligence in performing self-audits on a regular basis is the surest way to know where you stand.

How often should a self-audit be performed? The Code requires self-audits to be performed at least annually, but past audits, observations or FDA enforce-ment action may dictate the need for more frequent attention. If distributor managers keep in mind that their entire medical gas production operation is at stake (and in many cases, industrial gas production as well), there should be no problem in determining an appropriate timeframe between audits.

Mandatory Self-Audits
A periodic self-audit is much more than just a good idea—it’s the law! CGMP requirements state:

“Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for: (1) A review of every batch, whether approved or rejected, and, where applicable, records associated with the batch; (2) A review of complaints, recalls, returned or salvaged drug products and investigations.”
                                                                                                  
—21 CFR, 211.180(e)

Concern has been expressed that self-audits serve as a road map to a company’s deficiencies, guiding inspectors to violations. Experience has shown that this should not be a great concern assuming deficiencies have been addressed. The FDA has answered this concern only indirectly by addressing the issue regarding over-the-counter drugs in the July 1988 Human Drug CGMP Notes:

“Investigators should not, however, routinely ask to review OTC self-audit reports (a firm’s own audits and inspections of its operations), although FDA reserves the right to review such records.”

It’s confusing and very frustrating to be cited for multiple violations when the last inspection yielded a clean slate and nothing has changed!

One solution to the problem is to document that a self-audit has been performed and identify the various operational areas which were examined, while reserving detailed audit notes in a separate file. Absent some specific reason, an inspector would not normally ask to examine audit notes beyond the basic documentation.

Preparing for the Audit
Since the requirement to perform self-audits stipulates that procedures must be prepared, your written Standard Operating Procedures should give detailed instructions for performing the audit, including operational areas to be examined, how often, by whom, how the audit is to be conducted, corrective action and follow-up.

Checklists are most frequently used in performing self-audits. Broad terminology such as “Batch Production Records,” “Calibration Records,” etc. offer little detail to give a true picture of compliance or a basis for follow-up. If your checklist merely lists such operational areas by name, consider annotating each on a separate page with detailed observations. Record keeping and procedural deficiencies are usually sporadic events, and a simple “yes” or “no” box is meaningless.

Adulterated Product
To be able to recognize the most serious problems, an auditor should understand how the FDA views “adulterated product.” Product may be deemed adulterated within the meaning of the Federal Food, Drug and Cosmetic Act if methods or controls affecting quality, safety and purity are not in conformance with CGMP. It is important to realize that the FDA may deem product adulterated regardless of whether it is, in fact, bad.

Although some FDA field personnel may offer suggestions or appear helpful in other ways, never forget that they are not extensions of your compliance program and they are not consultants.

Consider this example: If analytical reports are unavailable for span gases, the analyzer’s calibration is questionable. Since the calibration cannot be relied upon as accurate, neither can the results of the sample’s analysis. If the sample’s analysis is invalid, no valid determination has yet been made as to the product’s purity. Since the benefit of the doubt is always given to safety, the product is deemed to be adulterated if it has been placed for distribution or distributed. If a company fails to initiate a voluntary recall of all distributed lots and takes corrective measures regarding the span gases, the FDA would likely consider a seizure action alleging “adulterated product.”

As seen in the above example, an auditor should always consider how the breakdown of one part of a system may affect another part of the system. Think in terms of “cause and effect.”

Performing the Audit
Self-audits are usually performed by compliance managers who are trained and designated members of the Quality Control Unit. For companies that fill medical gases at multiple locations, it may be more cost-effective for a branch supervisor to perform the audit, allowing the compliance manager to focus on follow-up activities or corrective measures.

When you perform your self-audit, don’t cheat. Glossing over a problem area will not hide it from an FDA inspector and may, in fact, only make the problem worse by calling your commitment into question. If a deficiency is found, even if it occurred a single time, make note of it. The Quality Control Unit will determine what, if any, corrective action is necessary. It may be helpful to make copies of records that do not conform to procedural requirements to be used in training classes. Typical examples include incomplete records and records not reviewed by Quality Control personnel.

Pre-dated Delivery Tickets
When inspecting a facility, the FDA is especially interested in confirming that product has not been shipped prior to analysis and final review by Quality Control. One pitfall that can be easily discovered and corrected deserves special mention because it recently led to a seizure action. Several distributors found themselves in an untenable position by the time-saving practice of printing delivery shipping papers the afternoon prior to actual delivery when the gases involved may not yet be ready. However, computer programs usually enter the current date of printing by default. A comparison of the shipping paper date with analytical data or other production records will indicate that product has been shipped the day prior to analysis and review.

Deficiencies in a medical gas program usually occur because employees fail to follow written procedures.

If you print shipping papers the day prior to delivery, your self-audit follow-up should include amending your written procedures to explain the practice and require drivers to date and initial shipping papers at the time of delivery. Verbal explanations to supplement written procedures are always questionable and can be avoided easily by adding a sentence or two to your written procedures.

Follow-up
After you have completed auditing your medical gas operations, you are only halfway through. Clearly, audits are not performed for their own sake. Since the objective is to discover and correct problems, you will need to formulate a corrective plan based on deficiencies discovered.

Deficiencies in a medical gas program usually occur because employees fail to follow written procedures. In most cases, the solution lies in retraining. In small companies where uniformity among branch operations is not an issue, managers may discover that actual practices are acceptable CGMP, but simply differ from written procedures. Rather than attempt to change established habits, you may find that amending your procedures to align with present practices is the simplest solution.

Finally, after you have documented the self-audit and corrective measures taken, immediately schedule your next review. Time has a way of slipping by and a program that began well can unravel before you know it. If you allow employees to become too accustomed to doing things the wrong way, getting the program back on track is extremely difficult. In the meantime, the FDA seems to have an uncanny knack for showing up at your most vulnerable time. Will you be ready?

Gases and Welding Distributors Association
Mike Lopez Meet the Author
Mike Lopez, NWSA safety consultant, is the owner of Safety & Compliance Associates, Inc. in Trussville, Alabama.