Prima can help. Click on problems that apply to you to see how Prima has assisted other clients. If your challenge isn't listed here, call us anyway; we're capable of more than can be listed.

Substitute “accounts payable,” “inventory tracking,” or a number of other terms for “engineering change” – those are some of the similar challenges we’ve tackled. We’ve solved them with a combination of services.

Initially, we process map the situation to determine what is really going on. Too often, it varies by shift, supervisor, or day of the week. Too often it reveals inconsistencies and contradictions within the system.

With a process map showing everything that is going on, we can then facilitate discussions to resolve factors contributing to confusion and help define the best process. We can also develop the communication tools to share the official process – procedures, process maps, training.

Process mapping was part of the solution to this problem, along with developing procedures and a documentation organization scheme to retain project bidding information. The process map outlined how to bid a project and served as an index to a repository of knowledge and past projects, as well as boilerplates and checklists developed by Prima to make the process more repeatable and efficient.

Prima’s client was inspecting incoming empty vials for a variety of glass defects. The defects were to be classified as minor, major, or critical, depending on the nature and severity of the flaw. Some defects were more subtle than others. The differences in severity were sometimes subtle also. We developed a defect manual that, for each glass defect, included a photograph, a schematic showing where the defect was likely to occur, and a verbal description of the degree of severity. The manual worked so well that we were asked to develop a defect manual that also included product, stoppers, and caps.

Prima met this challenge with a graphic procedure / index, wall-mounted at the work center. In addition to the routine steps performed regularly, it included a table identifying each periodic operation, a schedule of when to do them, and references to documents that provided detailed instructions for the periodic operations.

Like many problems, this one had a number of solutions. Prima will analyze your process and determine the approach best suited to the situation.

Unfortunately, procedures are often confusing and unhelpful, and this may be due to several problems, such as:

• chronologically describing tasks that are not chronological.
• attempting to describe in words something that is more easily understood with diagrams or photos.
• not writing for the user’s literacy level.
• inaccurate information (therefore casting doubt on any of its accuracy, and discouraging use).
• too much information, or too little.
• contradictory information relative to other sources.

Prima has helped several clients tackle this problem, enhancing quality, safety, and throughput, as well as achieving ISO 9000 or 14000 certification.

We first analyze the situation and determine the root cause(s). In one situation, procedures were historically so inaccurate that operators stopped even considering them! Our solutions include:

• graphic procedures, in a variety of formats, that are very easily understood.
• flowcharts in situations where decision points need to be highlighted.
• presenting the material in tables when there is a significant volume of discrete information to be shared. Well-illustrated equipment manuals are an effective way to present changeover, setup, operation, and troubleshooting information. In addition to being user-friendly, these document sets tend to be lean—a real plus when considering documentation maintenance costs.
• helping clients define the user communities and the most appropriate supporting documents for each.
• integrating electronic systems to ensure the latest copy is always available.
• ensuring document approvers are appropriate, knowledgeable, and add value with their review.

Prima has created various kinds of training materials, ranging from on-the-job training checklists to leader-led courses or from self-directed training manuals to computer-based training (CBT). We can help you determine which delivery method best meets your needs; sometimes more than one method is required.

For example, when asked by a client company to provide training materials for its maintenance team to meet a regulatory requirement, Prima developed materials for several different classes of equipment. The client planned to conduct leader-led courses to train the entire team initially. However, for new employees, something less time-intensive and more self-directed was desired. Thus, the final set of materials for each class of equipment consisted of an electronic presentation with instructor notes for a leader-led course, a CBT with an assessment activity, and a maintenance training manual for ready reference. These materials could be used together, to supplement one another, or separately, as dictated by needs.

Documents often contain contradictory information when information is repeated. This repetition can stem from at least two sources:

1. ill-defined or poorly understood document architecture (what type of information goes where, policy versus procedure versus guidelines, etc.) and/or
2. a knee-jerk reaction to problems and deviations. (A document will be updated to address a specific situation, without ensuring that the change doesn’t impact or contradict other documents.)

Prima strives to eliminate both. When creating new documentation, we use a detailed process map to develop a “document architecture.” This architecture defines the most logical location for information (e.g., a procedure, a reference manual, a log, or a form). Then, we do not repeat that information elsewhere unless absolutely necessary. We also ensure that document controls—addressing issues such as approvals, revisions, and training on the new information—are in place. The architecture—a blueprint for what to update with what kinds of changes—serves users long after Prima has completed the contracted work, ensuring procedures can remain accurate.

In a situation where we were working with existing documentation that lacked a well-defined architecture, Prima created a database to track document revisions and to cross-reference any related documents. If a document change was initiated, we knew of the other documents affected and initiated changes for those as well, deleting unnecessary repetition. This database, originally created for Prima use, later became an integral part of the client’s document-change system.

One way to eliminate reactionary duplication in response to an issue is to designate a team to review proposed changes. This team determines whether document revision is indeed the proper response and, if so, exactly which document(s) should be revised. Prima has participated in such team reviews, helping to identify the documentation requirements and to assess whether inadequate documentation is causing deviations. (Quite often it is the process or a lack of training, among other causes.)

All too often, the documentation required to support a change, product release, or installation is an afterthought. This is a particular challenge in heavily regulated environments; when testing and validation are complete, the documents to support production requirements must also be available before use.

Prima has solved this problem in several environments. In one case, we developed “operational drafts” of procedures to be used to support testing and validation. With a limited list of approvers, these documents could be quickly introduced. As problems arose during testing, they could be efficiently modified. When testing or validation was complete, implementation was simple.

In another approach, we participated in a team review of proposed engineering changes and identified the documentation requirements for each change. We developed and executed the documentation plan to ensure everything was ready when needed.

We also had a situation that challenged “Whatever It Takes.” An OEM called us on a Thursday afternoon as they loaded a truck with the machinery they’d manufactured, tested, and assembled over eight months. It was headed to Canada for installation, and they just remembered that part of their contracted delivery was documentation in French. We connected with our team member who speaks French fluently. She pulled an all-nighter and the manual was ready the next morning.

To combat these inefficiencies for a major client, Prima aided in implementing two processes to replace document routing.

1. All reviewers were asked to attend regularly scheduled document approval meetings. At these meetings, reviewers discussed the draft documents, the Prima writer electronically made agreed-upon changes, and the approvers signed the final documents.
2. Documents awaiting approval were placed in a document signing room, where approvers could sit quietly to review and sign them. One individual monitored the progress of each document and notified any remaining approvers that their signatures were still needed. Both processes significantly reduced delays.

After losing a number of contracts due to insufficient documentation, a manufacturer turned to Prima to help make their documentation more robust. Prima observed the affected processes, asked many questions, took a lot of notes and many photographs, and created detailed process maps.

Using these maps, Prima determined the document formats best suited to convey the information and began constructing the appropriate type of documents (procedures, charts, reference manuals.) The document architecture (a blueprint we developed based on the process maps’ information) defines what is where, and will aid in future updates as well as locating information.

The manufacturer is already using the process maps for marketing. And the final robust document set not only supports current product lines, but can be easily modified to support future products.

When a company that had never manufactured a pharmaceutical product was ready to add an active pharmaceutical ingredient to their product line, they called on Prima for help. Though the new process would use existing equipment, the process needed to be validated and the documentation updated to prepare for an initial FDA audit.

Prima wrote the functional specifications, the detailed design specifications, and the protocols and reports for installation qualification (IQ) and operational qualification (OQ). We also edited other qualification and validation documents for accuracy and consistency. In addition, Prima created document maps indicating all the documents (procedures, drawings, etc.) associated with each piece of equipment. These maps were used to ensure that every related document was reviewed for accuracy and updated as required. The documentation was completed on time; the company passed the audit.

A client was replacing an old sterilizer and called on Prima to help complete the validation documentation. They needed to verify that the sterilizer reached the specified temperatures and that sterilization was effective for various load types. Prima wrote the validation plan and the protocols for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Because the equipment was new, the client was unable to answer some questions. When we were unable to resolve the questions using vendor-supplied reference material, we consulted directly with the vendor. The validation was completed quickly and efficiently.