GMP Issues: Moving QA onto the Manufacturing Floor

Published on: 
BioPharm International, BioPharm International-08-01-2003, Volume 16, Issue 8

Many companies want to conduct quality assurance activities on the manufacturing floor. But implementation can be held up. Why?

Quality assurance on the floor is the intention of many QA departments, but implementing the idea is often deferred for months or even years. How can QA help support manufacturing? And is it true that additional QA staff must be added to meet this goal?

QA review may be performed "off the floor" by reviewing production-generated GMP documents. Commonly, a production supervisor or manager reviews and corrects any errors or omissions. QA is thus a final check for compliance, occurring just before lot disposition.

Quality "on the floor" involves stationing QA people on the floor during production to assist and support the manufacturing staff in detecting and solving compliance errors in real time. In theory, cycle time is saved, failure investigations are more likely to be effective (because all physical samples still exist), and QA-to-manufacturing communication is enhanced.

The Fantasy of QA on the Floor

Perhaps the difficulty lies in everyone seeing the QA presence on the floor as a panacea. For instance, a production person may see this as an opportunity to obtain on-the-spot permission for any kind of planned deviation, thereby avoiding that pesky paperwork and long wait for approval before moving forward. The QA person may see an opportunity to get some auditing work accomplished before the next planned audit. Management sees an opportunity to increase communication among groups, improve teamwork, and accelerate problem resolution.

All of these are highly desirable outcomes. Having the ability to approve deviations rapidly can help move an unstable product intermediate quickly to the next step. Failure investigations can begin when the evidence is available and intact. There is likely to be less second-guessing later when a team decides together on urgency, approach, and importance. And a QA person who spends more time on the floor will certainly gain a more accurate picture of the actual level of compliance than a person who appears for a day or two once a year. How effective can feedback on documentation be if it is given three months after a batch is completed on the floor? By that time, the error has likely been repeated on other batches and is becoming a habit.

So what are the challenges? Some QA colleagues will tell you that making it easy to deviate amounts to condoning or encouraging deviations. This bureaucratic logic assumes that making a process difficult is an effective method to discourage its frequent use. There is a grain of truth in this, but perhaps other methods are better.

One difficulty in making the human-in-plant strategy work is the variety and gravity of issues that can suddenly arise. The QA person may not have the experience to make good decisions quickly in all cases. Given time, and the intervention of people who are a bit remote from the floor, a different decision might be made. Some events are critical and will always need to be referred to the next management level for resolution. So how do you make the QA person useful, even when they are not godlike, infallible, and fully empowered for absolutely everything?

The Bogeyman of QA on the Floor

Any member of QA can be perceived as a cop or a judge who has the power to make production and QC staff do more work and justify their actions. The QA team should discuss this stereotype and address these concerns before launching a QA-on-the-floor program.

"I feel like you treat us as if we are guilty until proven innocent," says one production supervisor. Pointing out that an FDA or European inspector might make the same assumption does not seem to mitigate such feelings. Yet, other staff are likely to say, "Please come in. I want to show you how we do this and get your input."


Can a QA person be of real assistance, given this dual role of judge and counselor? Yes, however, careful support and training are needed for both QA and production staff, and realistic and clear project goals must be set. Don’t expect a QA presence to solve everything.

Essentially, the role of person-in-plant is to prevent compliance problems from occurring or to nip them in the bud and handle them appropriately. This person is valuable when you have relatively inexperienced production and QC staff — a condition that plagues process development and clinical manufacturing. When everyone is somewhat unfamiliar with the batch record, the procedures, or the new equipment, it is helpful to have someone checking the work and giving feedback. This person can be a member of the quality group conversant in the current practices acceptable to reviewers. The QA person can advise on how best to document a deviation, how to correct an entry, or what wording to use without creating more problems. A QA person can contact management on your behalf, approve planned deviations, and make notes for improving a document at a later date. They may even check calculations if they are properly trained. If QA staff have technical backgrounds, they can participate in troubleshooting and brainstorming. If not, they can draw out the technical people to articulate what experience or data lie behind a "gut feeling."

What about commercial product settings or routine production? The veteran operator may be so familiar with CGMP procedures and batch records that documents have not been read carefully for some time. This person may benefit from spot checks by colleagues or the QA person-in-plant. A process can drift as a result of staff innovations to existing procedures; perhaps the SOP needs updating. Such QA spot checks are ideally placed to reinforce recent training or new procedures. Random spot checks can be used for monitoring overall quality. In practice, spot checks occur when staff are available, and the results are extrapolated to other critical process points, whether appropriate or not.

Some Pitfalls

Getting people to buy into quality procedures is not done by force or righteousness, but rather by diplomacy and continuous communication and negotiation. The QA person needs to understand what things are minor and what are important. Making that distinction helps maintain mutual respect.

Placing a QA person on the floor may create a conflict situation. Especially at the beginning, staff may be fearful, and much of the trepidation may be unconscious. The QA person needs to allay those feelings and demonstrate trustworthiness and helpfulness. This may mean QA staff members do not carry notebooks in the facility, and their observations do not enter the internal audit database.

What kind of QA person can do this job? Ideally, someone with good communications skills, the ability to facilitate, and a technical background. Often, a person with prior experience in development, QC, or production has the ideal skill set and experience to fill this role.

Practice on the Floor

I saw a QA person-on-the-floor program put into practice in a development division. The production staff — old hands at CGMP — were completely occupied with the late-stage clinical product. So a separate team of experienced scientists — trained to innovate, but not accustomed to operating under strict CGMP — was assigned to do the first phase 1 batches for a new product.

The QA person was a source of on-the-floor training and guidance. He stopped people as they entered the gowning room and reminded them of the proper order for attire, preventing several SOP violations. He noticed that the batch record had a flaw, contacted the documentation department, and had it fixed in time for production use. And he did real-time reviews of many of the charts, sending them back on the spot to obtain the missing initials on cross-outs.

As a result, the completed review beat all cycle records for time with both quality and production groups. The initial investment of 40 to 50 full-time employee hours per week paid back approximately three to one in prevented deviations. Many minor issues were caught before they became larger ones during on-the-spot, real-time document reviews. One batch was aborted after the facility developed a drain back-up. Left to itself, the team would have continued the process, just in case the batch could be rescued. The development team came out of the experience with an enhanced understanding of CGMP, and the QA person came away with a clearer picture of the process equipment and its operation.

Getting Started

Why is it so hard to begin a program like this? The most common reason given is lack of staff. Often this is a vicious circle: The QA staff are busy trying to get through a backlog of old records and deviations, while well-intentioned production people are repeating the same errors and omissions because feedback hasn't arrived. The longer the wait, the more difficult starting gets, and the more remote becomes the chance of having a "spare" person on the floor.

Be creative. Start with a brief tour, if that’s all you can do. Or have each new employee spend one day on the floor. Some companies require all new operations and QC employees to spend one to four weeks in document review before starting their jobs. Why not offer new QA employees the opportunity to spend a few weeks in production? This can help build relationships and make staff aware of how their actions affect others.

Hire from within. What better person to do batch record review than a former operations person who has operated the equipment and followed the batch records? This person will have technical credentials and is in an ideal situation to propose practical new solutions that will meet compliance needs. Similarly, encourage people in the quality unit to experience other jobs.

Confront the fears. Perhaps the QA person feels threatened by entering production territory. As manager, support your people in their early ventures onto the floor. Recognize the effort and risk that go with any new behavior.

Negotiate truces, if needed. If the fear is that everything this QA "spy" sees will appear in the next internal audit report, acknowledge the validity of this. Can you agree that only highly critical findings on the floor will require notifying management? Creating time and space to let people address their own problems may improve their sense of ownership and encourage greater compliance.

Remember that quality is everyone's job. No QA specialist — no matter how confident, skilled, or tactful — can be solely responsible for quality. Production people who touch the product have the ability to ensure the quality. QA is like the canary in the mine, detecting and reporting what it senses. Share the responsibility, let everyone do their jobs, and work together to make the science and the compliance better. BPI