My coworkers and I regularly follow work instructions throughout the day and occasionally we come across issues or illogical steps within work instructions. Sometimes they are simple mistakes such as one or two steps, however other times an entire section of a work instruction is illogical. When this happens, we immediately contact quality and communicate what we have found and recommendations on remediating such issues. The employees who write the work instructions typically don’t have technical backgrounds, so they do not always understand the exact process of what they are writing. I would recommend my company hire technical writers who have experience performing similar job duties to those that they are updating or writing, so the writer has a strong idea of how the process should flow.
I have several examples of Quality department issues with work experience over the years. To be specific, I will talk about our quality department where I currently work. Unfortunately, depending on the organization, people are able to get away with things that may not be possible in other organizations for whatever reason. With the Department of Defense, there is a great deal of red tape. For someone to be held accountable for negative actions there will have to be a series paper trail as verification that there is an actual problem. Same with our quality management department. The quality team may utilize a PI to identify a known or existing problem however to implement change there is a ton of paperwork that has to be done. Due to this, most of the time, the DQ team will play nice and try to get the offender section to comply in a basic compacity. When that does not work out, meaning they decide to ignore the verbal or email corrective requests then a paper trail or write-ups began in order to document that someone identified a quality issue and that they took action for corrective measure however the offending department does not adhere to the correction so the documentation ensures that if anything unfortunate occurs due to the quality not being up to standards, the quality team will not be penalized.
I think the quality department can become to preoccupied with finding problems, which is not hard to do for any product. Therefore, a collaborative environment must exist so that if problems are located, proper guidance is offered to product managers. Equally, some problems should not be allowed to delay a project. When I did QC, I would pick up the phone and call the engineering to teajm to explain quick fixes. The engineering team was appreciative of me doion so.
Communication is one of the most important issues that arise between QA and other departments. Especially when there are multiple departments that need oversight by QA, certain things are not shared correctly. It is important to have uniform work and communication, so everyone knows what to expect. When issues are found at the final hour, resources are at risk of being wasted. The cost of unused materials can hurt a company financially. It is important that each QA personnel do the same work in the most efficient way, so production does not have to wait on some people but not others for results on the product. Clear and constant communication is needed for the healthiest relationship between these departments.
Based on your work experience in any company, what were some issues you found with the quality department and how would you fix them?
For example:
I work in the manufacturing department of a medical device company but all of our documentation goes through Document Control. As a result, projects get delayed because certain modifications in quality system documents do not meet the standards of Doc Control. A way to eliminate the waste in time from the back and forth between Document Control and Manufacturing is to state the standards for quality system documentation in a procedure. Therefore, the engineers have a clear understanding of what is acceptable in there redlines. While document control has a set guideline as to how documents are supposed to look in terms of formatting, referencing, etc.
As a technician at the FDA, I make media such as broth and agar for certain for food samples and then physically turn them into quality department to either get approved or rejected. Because I make media for the microbiology department, issues have occurred where agar was being rejected due to not being checked for approval on time, causing bacteria to grow due to improper storage. The agar could have been make correctly, but if a specialist did not show up to approve of it, place it into the proper conditions such as a refrigerator or in a dark cabinet due to light sensitivity, then all of the media made has to be tossed. This should be fixed through human resources. The several times these situations have occurred was always because the staff did not show up for work. There are only three specialists who can approve of the media which also makes it difficult. I believe that if more people were hired or trained to assist then there wouldn't be much of a problem.
Based on your work experience in any company, what were some issues you found with the quality department and how would you fix them?
For example:
I work in the manufacturing department of a medical device company but all of our documentation goes through Document Control. As a result, projects get delayed because certain modifications in quality system documents do not meet the standards of Doc Control. A way to eliminate the waste in time from the back and forth between Document Control and Manufacturing is to state the standards for quality system documentation in a procedure. Therefore, the engineers have a clear understanding of what is acceptable in there redlines. While document control has a set guideline as to how documents are supposed to look in terms of formatting, referencing, etc.
While the quality department that I work in has significantly improved from when I first started to now, there is still something I would fix. The main issue that I would fix is that no one in quality has worked in the lab, and the only person that worked in the lab before worked in there a long time ago before we got half of our instruments. They make decisions for the lab, but they do not take into account what the lab truly entails in the day to day. They end up piling on more work and get upset when the work does not get done. I would put into place that a policy can not be put into place without the consultation of a few lab members, and if the policy is truly necessary, then the lab members should be a part of the MOC process where they can amend it to work with the lab.
When I worked in Post Market Surveillance, one issue we noticed was the ability to gain appropriate information in a timely manner. Since Post Market deals with a lot of customer complaints (the customer being the surgeons), communication for additional information is facilitated by sales reps that may or may not be as responsive as needed to gain a better understanding of the situation to determine the root cause and investigate if further action is required. A way to mitigate this issue would be to improve the reporting structure of various departments to increase communication and complete investigations in a timely manner as a complaint that may need to be reported to the FDA or EU must be reported within a tight timeframe.
In my current role, we work very closely with Quality and have found that having every protocol and report reviewed by many members and Quality can slow down the process of completing experiments on time. To combat this issue it may be necessary to hire more resources to review documents or change the system to only require quality review at the conclusion of the experiment so all data can be reviewed at once.
Based on my past work experience I have faced some difficulties about implementing my ideas and introducing my scientific knowledge into the procedure I was hired to work on. It seems that a simple change cannot just happen as quickly because it requires going through the change control process. I have waited for 3 years but still didn't get to see any outcome. Many times, the company doesn't want to spend that much money and time for the change control. I think it could be improved by having a good relationship with the overall change control department and maintain regular communications about the status of the proposed ideas/change.
Like @bb254, I also work for a company that has a document control system that wastes a large amount of time and resources. While I understand the need for a quality management system and the need for quality to review and control any documents being implemented by the company, sometime document control can be way too involved. I have personally had documents rejected for the most absurd reasons. Most recently, I had a document rejected for putting a period after an abbreviation on one of my training records. While there is no company policy saying this cannot be done, and no other department has a problem with it, document control insists it goes against Good Documentation Practices. Even those these problems do exist and they can create a lot of waste and make extra work, the best way to get around them is to face them head on. I have found that discussing the issues with Doc Control and Quality may not always resolve them, but will allow me to complete things the way they want them done to get them approved quicker and use my time for other purposes.
An issue that I’ve had while working in a quality department was with process change controls. A company that I worked for had an issue that resulted in a huge million-dollar complaint from a customer. The customer’s product was ruined with a substance that formed from adding a new chemical during the process of making the product. The company outsourced the use of this chemical, and the company that provided it, had a change that was made internally to that particular chemical. Well, the change wasn’t a big change, and it wasn’t reported all the way up to the top. Turned out that the chemical change caused a buildup somewhere else down the line during manufacturing which then broke off onto the finished product. This issue could have been avoided if the proper process change form was used. This form shows what part of a chemical was changed and enables the company to make sure the change is acceptable for use in their product. Following process change protocols would have prevented this from occurring.
Based on my work experience in the companies I have worked at one of the challenges I have face everywhere is communication. This challenge has been in quality and outside of quality. When I worked as a Biological Quality Lab Analyst, I would test samples for microorganisms as well as complete environmental monitoring in certain filling areas. Whenever there was an environmental discrepancy on the floor an environmental discrepancy report would be initiated and then sanitation would clean, and we would go in and sample and production could then resume. While this seems simple, we would always get told the wrong time and go in and sample before cleaning was finished or production would be waiting on us to sample. If effective communication were made between all parties involved these issues could have been avoided and prevented delays in starting production back up. I would fix the issues by having the parties involved to still sign off as they were doing and require the next party that is completing the next task to document their signature, date, and time they were taking over to close out the environmental discrepancy report.
Solving quality management issues keeps your life sciences organization on the right side of the FDA. However, compliance isn’t the only benefit. Excellence in quality management helps your organization produce the best medical devices on the market. It helps you get your device to market faster and gain a competitive advantage. Quality management can build your brand reputation and keep you from costly customer complaints and product recalls. Successful management and leadership of the quality department for an organization involve an integrated approach that includes a communication network that extends both horizontally and vertically within the organization as well as outward to customers and suppliers. The top challenges identified below are the primary constraints to achieving effective quality assurance. Each challenge is defined, concerns indicated and successful resolution identified. Most of these challenges are interrelated; therefore, one will often affect others. These challenges are especially critical in a new or turnaround operation where quality has either not been established or otherwise ignored for an extended amount of time. An organization may also experience multiple challenges in the same timeframe as well as high turnover, primarily in the quality department.
1. Management Commitment – All the challenges listed here connect to management commitment. Failure to communicate the appropriate details for management will almost certainly lead to a lack of support. Identifying and determining the details, cost, and justification, setting a timeline, and getting approval for completing all necessary activities is an essential first step in a plan to successfully address challenges and reduce risk. Providing management with updated status on these challenges is also important.
2. Inadequate Quality & Production Planning – It is critical for the sales function to have the technical and logistical capability as well as team support to produce reasonable quotes. Without a proper team feasibility review with all relevant stakeholders before committing to a price and subsequent PO, sales may underquote. This deficiency can lead to compromises in quality. The feasibility review should also include risk analysis to stay ahead of any potential technical or logistical issues. Make sure all customer requirements derived from drawings and specifications are clearly understood by all internal and external stakeholders. If the organization needs other specifications to further clarify “grey areas” or otherwise protect them, include those as well. Do not assume you cannot negotiate existing or new specifications. Negotiating specifications could increase the organization’s capability to produce the required product as well as minimize cost for the customer and organization.
3. Quality Support for Problem-Solving and Continuous Improvement Project Teams – Ongoing efforts to resolve problems and otherwise continue to make improvements based on the importance of issues is imperative to maximize the effectiveness of an organization as well as stay ahead of the competition. Failure to form and maintain these project teams as well as include the appropriate team members will lead to higher scrap rates, decreased customer satisfaction, and increased risk for the organization. Team leaders that maintain priority-based action item lists with firm completion dates should drive these teams. Team leaders should keep top management in the loop to sustain their commitment to the resources needed to address the challenges.
4. Employee Communication and Engagement – Keeping all employees in the loop is essential to productivity and quality as well as the morale of the organization and can drive a positive culture. This approach is a two-way street that includes communicating with the employees as well as getting input from employees. Failure to make these connections will lead to gaps in information shared both ways that will cause a decline in quality and productivity as well as employees’ willingness to contribute. Methods to communicate to employees include monthly meetings, posting (current) results, newsletters, etc. On the other side, maximizing engagement includes involving employees in corrective actions, continuous improvement initiatives, training needs assessments, etc. Communication and engagement also involve managers visiting work areas on a regular basis to facilitate informal two-way conversations.
5. Procedures and Instructions not Written or Updated – This is one of the most common findings in ISO-9001 QMS third-party audits for organizations that certify to this standard. Some organizations rely too much on verbal communications and partially retained memories. The extent of documentation should be determined based on the complexity and interactions of the various processes as well as the scope of training for the employee. A guideline to use for developing a work instruction set is to have a basic version visible at the point of use for those who perform the task regularly. Also, have a more detailed version taken from the training documentation available at the point of use accessible by recently trained employees or employees that have not run the process for a while. There should also be a system of tracking documents to assure the most current version is available.
6. Breakdown in Customer Relationships – This is usually a result of poor or declining quality or delivery and related communications. Accompanying this is a poor follow-up on issues or otherwise no substantial progress to resolve issues. It is critical to maintain ongoing communications on the status of any issues that include an action plan with identified dates of completion. Depending on the significance of the issue, you may communicate by email or phone. Use the phone when speed and clarity are essential. Document calls by following up with emails to primary stakeholders.
7. Training and Development – This is a systemic issue for the majority of organizations at some level. There is a tendency to get new employees to the work areas as soon as possible. Managers that interact regularly with new employees in their work areas indicate that employees often express concern about training for their job. Employees are afraid to approach their supervisor for fear of criticism for not retaining all the information communicated to them during their brief training session and that it is not available at the point of use. The ideal training program should consist of an approved documented program that considers past experience and entails the level of complexity depending on the type of job. This hands-on approach should include describing the job, showing them how to do the job, and then letting them do the job to validate their training. The trainee should also be comfortable asking follow-up questions, and there should be a mentor assigned to the trainee for a designated amount of time, depending on the level of complexity.
8. High Turnover and Shortage in Quality and Production Employees – High turnover rates can have a substantial effect throughout all levels of the organization. Reasons for high turnover can include inadequate pay, lack of appreciation or being mistreated by the supervisor, and insufficient training related to performance issues (employee leaves or is terminated). As the popular phrase goes, “people are your best resource.” This should always be on the minds of management. Ongoing and adequate training and development, praise for a good job done, and appropriate pay for a given job will go a long way to retain employees at all levels of seniority as well as affect the bottom line.
9. Lack of Investment in Quality Equipment or Quality-Related Production Equipment – After setting priorities for equipment repair, refurbishment, or replacement through problem-solving or continuous improvement teams, management needs to plan ahead to have the financing available to address the challenges. Many companies have great expectations on the front end of problem-solving and continuous improvement initiatives but stall out due to declining or shifting priorities. Return on investment for many capital projects is typically one to three years based on quantifiable and qualifiable considerations. Management must have the strategic vision to maintain the commitment to move forward with these investments.
10. Supplier Evaluation and Development – Suppliers are an important part of the quality equation. All too often, suppliers fall off the radar until they have issues. Frequently, these issues are only taken seriously when reject supplier material reaches the organization’s customer. Suppliers providing material with critical characteristics should be high on a priority list for evaluation and development. Purchasing and quality should thoroughly assess all critical suppliers before their approval for use. In some cases, dual sourcing could also be considered as a contingency when a supplier is unable to provide an acceptable material.
Within my regenerative medicine company, QA tends to get overwhelmed by the amount of paperwork and documentation that they have to review and create as well as delays in releasing materials needed for processing. Every time a process is completed by a Manufacturing Associate, the documentation needs to be reviewed by management and QA to make sure that there is GMP compliance as well as process compliance. Also, if an issues arises during a process or training run, QA is responsible for reviewing the Notification of Event or Protocol Discrepancy Report that are written for each process deviation. Sometimes there could be multiple batch records given to one QA associate in one day and the batch records need to be reviewed before completion of the entire process run, which could be 3 days to 35 days depending on the client and process procedures. Since that could happen, sometimes other batch records are not reviewed for a number of days, which could lead to delays for the release of the product to the patients, especially if mistakes are caught during the review. Another issue is material release. For clinical and commercial manufacturing of these products, materials need to be released by QA before being used in processing. Some materials could be as simple as pipet tips or even specific labels that is required for use. Sometimes if a batch record is made late or the warehouse doesn't realize that they have run out of an item since there was a gap in processing, there could be delays up to 3-4 hours due to materials not being released, which would also push back the processing time. This could lead to large deviations especially if the process requires certain steps to be done within a specific time window that is allotted for the cells to need a change in media to needing a break from incubation.
I understand where the annoyance is coming from. As someone who works in quality, there are definitely outlines in the SOP for certain documentation that seems almost too time consuming when the important information we know is there. I think another issue/concern with all of the documentation (with regard to time) is how much time it takes for one person to review, just for another department to adjust with what they think is correct, and the back and forth continues until many weeks have passed... no progress made. This is especially difficult when it is one specific department or approver that takes FOREVER to look at something you create, just for when they do take a look, there are "errors" that need to be adjusted, and then the process repeats. A strange challenge my company came across was where a certain SOP from the production team was greenlit (not very much changed, just an adjusted appendix), but someone found an error (a copy paste thing from the previous revision) after the whole document was approved. Clearly this was just human error, and the approvers glanced over the 50 page document..., but the issue comes where a CAPA had to be launched, when the error was as simple as one section just had to have an adjusted title. With all this, it's obvious to see how productivity stalls when something small gets caught in the gears. Finally, although every department has their own method of documentation control (and we have one large system where all this information is held), it can be very challenging when only ONE person is able to access the documents required from their own department's files. Having one coherent system, or at least great communication can solve most of these issues, and I don't know if that is being stressed enough across different departments.
The issues that I have seen throughout the quality department working in the industry is the inconsistency of ensuring proper protocols are followed. If researchers were not being QA'd certain protocols were not executed as properly and a lot of times QA was aware. Even when paper work is not being completed the quality department should ensure researchers are conducting research with excellent quality throughout the study.
