Drug manufacturers are turning to temporary workers to fill gaps in production, and to save on salary costs. This leads to serious training issues. “In a regulated environment like ours, the matter of training is usually pretty well addressed—with the exception of the contingent labor piece,” says Steve Sawin, president of Operon Resource Management, a firm which helps life sciences companies manage part-timers. “Many companies do a poor job in terms of process and product training of the contingent worker, especially up front prior to placement.”
The challenge for manufacturers? “How do we make this resource ready to hit the production floor to make a contribution initially and to meet the expected learning period?” he says. “On the premise that quality and compliance can otherwise be maintained, it becomes a financial trade-off: learning curve attainment to idle labor cost.”
Managers will say, “Why do I want to invest the time in training this person when they are only going to be with me a short period of time?” Sawin continues. “Another underlying reason is that these group leaders or supervisors just do not have the time. In the interest of cost-take-out, their numbers have been reduced or their scope of work has been increased.”
Sawin recommends that manufacturers have an established, comprehensive “on-boarding” process that includes a thorough qualification screening, tailored company orientation and process training, and close management and supervision of those workers once they’re on site.
Our interview with Sawin follows. For an audio interview, click here (registration required).
PhM: What are the biggest labor issues that drug manufacturers have today (particularly within their facilities), and how are these issues related to training?
S.S.: Cost! White House to Your House healthcare costs are an issue. Cost pressures are either at the manufacturer’s doorstep or they’re coming! Margin squeeze will force manufacturers to look at all cost drivers and few are bigger than labor. So I see one of the biggest challenges that drug and device manufacturers will be to do more for less in terms of labor. And one way to do that is by developing a flexible workforce; so you only use what you need and you only pay for what you use. And clearly a tool to accomplish that is contingent labor.
But back to the issue of “training and labor”: In a regulated environment like ours the matter of training is usually pretty well addressed; with the exception of the contingent labor piece (or temporaries). Too often, because of the “temporary” nature of the worker’s tenure, many do a poor job in terms of process and product training of the contingent worker; especially up front prior to placement.
PhM: Is the issue of contingent labor training becoming more significant for drug manufacturers in light of recent trends towards leaner, more nimble workforces? Has it also become a more significant regulatory issue in your estimation?
S.S.: You know, I am not as close to the drug manufacturers as I am to the device folks. But I have to believe that the forces of cost reduction are the same. For any operation in the manufacturing process that has a relatively short ramp-up or learning period, and where demand for this resource is not always steady, contingent labor is an option. Then that issue is how do we make this resource ready to hit the production floor to make a contribution initially and to meet the expected learning period. On the premise that quality and compliance can otherwise be maintained, it becomes a financial trade-off: learning curve attainment to idle labor cost.
In terms of a current regulatory issue, I don’t know! But we can all be sure that if the labor that we put on the production floor does not meet regulatory or quality systems standards they will make it an issue.
PhM: What do manufacturers really struggle with, specifically, regarding the training of part-time or outsourced workers?
S.S.: I think they really struggle with the fact that generally speaking the outsourced provider does not provide the needed general process or maybe even product training that they need, so they, the manufacturer is faced with doing it themselves. And the reaction typically is ‘why do I want to invest the time in training this person when they are only going to be with me a short period of time’. Another underlying reason is that these group leaders or supervisors just do not have the time. In the interest of cost-take-out their numbers have been reduced too or their scope of work has been increased.
PhM: What few basic practices do drug manufacturers need to put in place to meet these challenges? How can training become as flexible and thorough as staffing needs to be?
S.S.: That’s a good question; and I am assuming you mean in terms of contingent or temporary labor? I think it varies widely depending on where the manufacturer in terms of their internal training program or training culture; and where their staffing provider is in term of their value proposition.
There are some very good examples on the medical device side on how they have addressed this. And at the risk of inserting a commercial here, we have worked with several organizations to, not only address training of temporary labor but to address the whole “on-boarding” process for manufacturing labor. This has included:
- Tailored Application & Qualification
- Tailored company Orientation
- Tailored Process Training
- On-site labor placement, optimization and management
So it could be as easy as selecting the right partner who brings the proper value proposition to the relationship.
PhM: Have you seen an increase in on-site training—where consultants or solutions providers come in-house to accelerate or perform on-demand training?
S.S.: Not really. But there is a reasonable dose of the “not invented here” culture . . . we know our needs best so we will do it ourselves. And this may be more visible in the bigger organizations.
PhM: Are web-based training services and modules expanding and helping?
S.S.: I see a lot of web-based training materials being developed and a lot of it is very good stuff. But I don’t see it as much in terms of manufacturing workers. However, I would suspect that too will change in time.
PhM: As workforces become more global and diverse, language becomes an obstacle to training. To your knowledge, have regulators raised concerns about whether training materials can be understood by workers? What are proactive manufacturers doing to make sure their materials are understood by speakers of various languages?
S.S.: I don’t know what issues regulators have raised regarding the language issue, but I see more and more (almost all) organizations instituting an English-Only environment. And I see them backing that with English Comprehension testing. The speaking and understanding skills are important too…..and are usually assessed during the balance of the on-boarding process (orientation & training).
PhM: Do manufacturers seem to have a handle on exactly who is performing what tasks, and if they’re even qualified to do so?
S.S.: Boy, that one is all over the board! I think for the most part manufacturers have designated responsibilities by function—for example, the group leader or department manager is responsible for ensuring an understanding of cGMP’s.
PhM: Related to the above, are paper-based training records a problem, and is automating training and recordkeeping something most manufacturers need to do more of?
S.S.: Yeah, most are electronic records of the training requirement. Matter of fact many have unique barcodes assigned to individual operators. When the barcode a work-order for a certain product, it will indicate whether they are qualified in terms of process, product or machine training.
In other environments that we work with that are more manual the DMR has a daily start-up checklist that prompts the operator and the supervisor to go to the training record in the DMR to determine compliance. i.e., is this operator trained on this part or product.