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Featured Article from The ATA Chronicle (June 2006)

Guess What: Time for Your Audit (and I don't mean by the IRS!
By Michael Collins

The following originally appeared in spring 2006 issue of the CATI Quarterly, the newsletter of the Carolina Association of Translators and Interpreters, an ATA chapter(www.catiweb.org). It is reprinted here with permission.

Translation work in the medical and pharmaceutical arenas is accompanied by a different set of requirements than is seen for other fields. The Food and Drug Administration and other regulatory agencies keep a close eye on companies and institutions that develop and use products in human beings, and rightly so: one mistake can result in injury or even loss of life.

As translators and interpreters, most of us are acutely aware of our responsibility to do our work carefully and accurately for this very reason. We are accustomed to being asked to provide back translations, translator résumés, certifications, and other means of verifying that we have done our work professionally to the best of our ability.

Nevertheless, it came as a surprise when one of my business partners informed us that one of our pharmaceutical clients wanted to audit us. My initial response was something along the lines of: "They want to what ?"

We were not the only ones-the auditors were also rather surprised that we had never been audited before. What followed was a period of adjustment as we came to terms with what exactly there is to audit about translation service providers.

The auditors were as much in the dark on this point as we were. The initial list of items for inspection that was sent to us included items like "Tour of the Facility," "Personnel and Training Program Records," "Regulatory Inspection History," "21 CFR Part 11 Compliance, where applicable." The closest we had come to some of the items was translating them. Nevertheless, our auditors proved very open-minded and ready to learn; they adapted the program based on our input and information from another translation service provider.

Our final list was much more familiar-looking:

• Tour of the facility;

• General overview of the organization and facility

- Personnel records
- Job descriptions
- Training opportunities for staff;

• Record retention policy and procedures

- Storage and archiving;

• Standard operating procedures

- Quality control/quality assurance
- Linguistic resources, translator selection, background, training
- Translation tools and methodology
- Outsourcing;

• Project management;

• Confidentiality procedures;

• Disaster recovery and business continuity plan; and

• Client type breakdown.

We were now ready for the actual audit visit.

The auditors asked us to set aside up to two days for the review. For a small office like ours (six full-time employees), this represented a considerable investment in time, as it would occupy half of our work force for the entire audit period.

As the reader undoubtedly knows, most translation agencies are not very large-just a few in-house staff, a long list of contract freelancers, and little or no budget for training programs, ISO 9000 certification, or other activities that are common at larger corporations. In addition, we have very little in the way of production facilities and raw materials, few on-site safety hazards (other than what may be lurking at the back of the refrigerator), and very little regulation to deal with.

Except for a few very big players, our industry is composed primarily of small- to mid-sized companies that are exempt from the more onerous and restrictive regulations. Would auditors who were accustomed to reviewing production lines and reams of personnel training records understand our lean operations, or would they find us wanting and recommend ending our collaboration with their company?

As part of our preparations, we collected samples of all the forms we had created over the years to help us track our work. These included:

• Proprietary statement (to be signed by employees and contractors);

• Confidentiality statement (to be signed by employees and contractors);

• Job checklist;

• Work process checklist;

• Sample certification form; and

• Employee handbook with job descriptions.

In addition, we drew up a project procedure list outlining the process we follow and our translator selection guidelines. We also listed hiring procedures, our archival and document storage policy, training options, and other relevant procedures. We gathered statistics on types of clients and volume handled.

As we prepared for the audit, we discussed the "intimidation factor," that is, the natural tendency to feel defensive whenever an authority figure starts looking over your operations. We made up our minds to relax, be completely open, treat the audit as a learning experience, and let the chips fall where they may.

The auditors arrived early in the morning and began with the "tour of the facility." To our great appreciation, the two women delegated to check us out approached the task with a positive attitude that quickly put us at ease. As they toured our small office, they asked each employee what his or her job was, how long they had been there, what their specialties were, etc. They were interested in the tools each person used and had available, particularly technical dictionaries, both paper and online.

When reviewing our network/information technology equipment, they quizzed us on our backup policy. We were able to describe the system we use, where we store tapes, other backup options, and more. They offered several useful suggestions, something which was to set the pattern for the audit. These ranged from suggesting that we consider an online backup company option, to cautioning us not to leave our backup tapes in a coat pocket when we take them out of the office.

A look at our filing system brought predictable questions: How long do you keep files? How secure are they? Do you tell your clients what your storage policy is? Recommendations included converting to more fire-resistant filing cabinets, keeping scanned versions on electronic media off-site, and documenting our archival and security policies.

Of particular interest to the auditors were our procedures, and any documentation we might have of them. We produced blank copies of our job checklist and our "problem projects" checklist, and showed them our daily tracking schedule. They quizzed us on how we managed projects, how translators were selected for jobs, and other aspects of job tracking. They sometimes circled back to topics, and it was not clear to us whether they were trying to understand or just making sure we were giving the same answers to the same questions.

The other topic that they spent quite a bit of time on was our translator selection process. It was clear that they were striving to reach a comfort level regarding how their company's work was being handled and by whom. Questions like the following were asked repeatedly:

• Do you have résumés for all your translators on file? How often do you ask them to update their résumés?

• How do you know they are qualified? Do you have copies of the tests you have given them?

• Who checks your translators'work?

• What is your quality control process?

• Who checks translations in languages you cannot read in your office?

• How do you know a job is complete when you send it to us?

• How do your staff and your translators keep up to date in the industry, and how do you know they do?

• And many, many others...

It gradually became clear that the auditors really knew their business and were truly trying to understand ours. We did not always have the answer we thought they might have wanted to hear, but we were often pleasantly surprised by their reactions.

For instance, when the question of a disaster recovery plan came up, they wanted to know: Do we have one, and what would we do in the event of a major disaster? We could not honestly say that we had a plan in place, other than to try and work out of our homes. However, several of us had attended a local chamber of commerce workshop on how to start creating a disaster recovery plan a few weeks ago and were able to show them the materials. As it turned out, they were not disappointed that we had no plan, but rather were pleased that we had actually taken a concrete step toward creating one.

The same was true regarding employee and translator training. We could not point to a large, well-funded, and well-organized training department. However, we stressed the fact that our company pays for employees to attend ATA and Carolina Association of Translators and Interpreters (CATI) conferences and other field-related workshops and seminars. We also pay employees for continuing education in the field of translation and interpretation. The auditors accepted this very positively. We were able to produce some of the CATI, ATA, and software training certificates from past activities.

Indeed, many sets of questions and inquiries sent us scrambling to round up documentation: old translator tests, résumés, and training and continuing education certificates. For other activities we had no documentation at all. In the end, this constituted the area where they most took us to task.

Over and over again, they expressed confidence in our processes and resources, and accepted the fact that since we have had very stable staff over the years, we are all very familiar with our processes. But that same familiarity kept us from feeling the need to document thoroughly many of our processes. If you are already doing something, they asked, why not take credit for it? Document it so that you can take credit.

• If you are paying for people to attend conferences, place copies of the certificates in their folders, and have them update their résumés once a year.

• If you are following a consistent backup policy, make a checklist to show you are following it.

• If you test software in your office, make a note of it and file it.

• If you are doing a final in-house check for completeness, indicate it in your quality policy.

• Make and keep a list of all the languages you have worked in.

• If you have a security policy, write it down and when you train people, write that down, too.

The theme was recurrent and insistent: If you are already doing it, take credit for it. At some point, they reminded us, another set of auditors is going to come. And nothing will make them go away faster than if you can quickly produce documentation on the issues that interest them.

At the end of the day, the auditors informed us that they would not need to come back the next day. We could expect their recommendations in the form of a written report in a few weeks, and a return visit in two years or less.

For our part, we took a long list of helpful suggestions with us about how to improve our organization and...how to take credit for what we are already doing.

As the auditors prepared to leave, they remarked that they appreciated that we had not become edgy and defensive by the end of the long day. It seems that many of their audits start out well enough, but the strain eventually causes some irritation to surface in some cases. That is perhaps entirely understandable, for who likes to have their day-to-day operations scrutinized and criticized at length?

However, we couldn't help thinking of our pre-audit decision to relax and treat it as a learning experience. In the end, our attitude went miles toward making what could have been a stressful and depressing experience into an opportunity for learning and growth.

On a final note, it is clear that freelance translators and interpreters can benefit from what we experienced as well. Surely it makes sense to update your résumé each time you attend a conference or publish an article. Surely agencies who receive your updated résumé on a regular basis will be positively impressed that you are active in the field and busy expanding your professional knowledge. After all, you went to the trouble of attending that training course-why not take credit for it?

 

Michael Collins is co-owner of Global Translations Systems, Inc., which he helped found in 1992, and a former Fulbright scholar to Yugoslavia. He currently serves as vice-president of the Carolina Association of Translators and Interpreters, an ATA chapter. Contact: mike@globaltranslation.com.