Tapemark: Glossary of Terms

Glossaryof Terms

Term	Definition
2P	Process Preparation. 2P is a facilitated team-based design process (kaizen event) that uses simple tools combined with the creativity of people to Prepare Process breakthroughs that meet the needs of all stakeholders.
3P	Product and Process Preparation. 3P is a facilitated team-based design process (kaizen event) that uses simple tools combined with the creativity of people to Prepare Product and Process breakthroughs that meet the needs of all stakeholders.
483	The Federal Government form used by the FDA inspector to document non-conformances to Federal law.
510(K)	See Premarket Notification (PMN).
5S	Sort, Straighten, Shine, Standardize, Sustain A Lean manufacturing method to remove what is not needed and keep what is needed; place things where they can be easily reached when needed; keep things clean in the workplace; maintain cleanliness; and teach an attitude to inspire pride and adherence to established standards.
7 Forms of Waste	Overproduction, producing more than demanded or before it is needed. Transportation of materials. Motion of workers or machines. Waiting for parts to arrive or a machine to process. Processing waste; non-value added steps; doing more than what is needed. Inventory: raw material, WIP, finished goods. Defects.
Abbreviated New Drug Application (ANDA)	Application made to the FDA for a generic, bioequivalent version of a branded drug. The first company to receive FDA approval of an ANDA receives 180 days of market exclusivity for the generic drug.
Acceptable Quality Level (AQL)	The maximum % or proportion of variant units in a lot or batch that, for the purposes of acceptance sampling, can be considered satisfactory as a process average. AQL is also used as a general term for finished product acceptance testing.
Acceptance sampling	Inspection of a sample from a lot to decide whether to accept that lot, in reference to a continuous scale. Two types, including attributes sampling and variables sampling, are used to note the presence or absence of a characteristic and the numerical magnitude of a characteristic.
Acceptance Sampling Plan	A specific plan that indicates the sampling sizes and associated acceptance or nonacceptance criteria to be used.
Accreditation	Certification by a duly recognized body of the facilities, capability, objectivity, competence and integrity of an agency, service, or operational group or individual to provide the specific service or operation needed.
Action plan	A specific method or process to achieve the results called for by one or more objectives. May be used as a simpler version of a project plan.
American National Standards Institute (ANSI)	A private, nonprofit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. It is the United States' member body in the International Organization for Standardization.
American Society for Quality (ASQ)	A not-for-profit association that develops, promotes and applies quality related information and technology for the private sector, government and academia.
Analysis of Variance (ANOVA)	A basic statistical technique for analyzing experimental data. It subdivides the total variation of a data set into meaningful component parts associated with specific sources of variation in order to test a hypothesis on the parameters of the model or to estimate variance components. There are three models: fixed, random and mixed.
Assignable cause	AKA "special cause." A name for the source of variation in a process that is not due to chance and therefore can be identified and eliminated.
Attribute data	Go/no-go information. The control charts based on attribute data include percent chart, number of affected units chart, count chart, count per unit chart, quality score chart and demerit chart.
Audit	An independent examination of a work product or set of work products to assess compliance with specifications, standards, contractual agreements, or other criteria.
Backing	The relatively thin flexible material to which the adhesive or other primary material is applied.
Batch	See Lot.
Black Belt (BB)	A full-time team leader responsible for implementing the Six Sigma process improvement projects — define, measure, analyze, improve and control (DMAIC) or define, measure, analyze, design and verify (DMADV) — within the business to drive up customer satisfaction levels and business productivity.
Calibration	The comparison of a measurement instrument or system of unverified accuracy to a measurement instrument or system of known accuracy to detect any variation from the required performance specification.
Cause and effect diagram	AKA "Fishbone." A tool used to analyze process dispersion and illustrate the main causes and subcauses leading to an effect.
Center for Biologics Evaluation and Research (CBER)	Protects and enhances the public health through the regulation of biological and related products including blood, vaccines, tissue, allergenics and biological therapeutics. (FDA)
Center for Devices and Radiological Health (CDRH)	Responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. (FDA)
Center for Drug Evaluation and Research (CDER)	Assures that the drugs available to the American people are safe and effective. (FDA)
Center for Food Safety and Applied Nutrition (CFSAN)	Responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. (FDA)
Centerline	A line on a graph that represents the overall average (mean) operating level of the process.
Certificate of Analysis (COA)	Describes quality control data, such as physical and/or analytical test results, for a particular lot of product. The data were generated by testing the product against established testing methods. It contains the name of the product, lot code, test data, test specifications, and a signature of the party certifying the test results as accurate.
Certification	The result of meeting the established criteria set by an accrediting or certificate granting organization.
Child resistant (CR)	A package that will pass a test protocol administered by the US Consumer Product Safety Commission.
Class I	An FDA classification of medical devices, Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class I devices are subject to "General Controls" as are Class II and Class III devices. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.
Class II	Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. Class II devices are also subject to special controls such as special labeling requirements, mandatory performance standards and postmarket surveillance. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.
Class III	The most stringent regulatory category for devices, Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices include replacement heart valves, pacemakers, and implanted cerebella stimulators.
Closing	An important phase to process development for learning and growing. The project is evaluated for what was learned, what went well, and what to change for next time.
Code of Federal Regulations (CFR)	Code of Federal Regulations, Title 21 contains US regulations that directly apply to biopharmaceutical development.
Cohesive	Sticks only to itself.
Cold seal	The joining of two materials by application of pressure.
Commercialization	The phase in the product cycle to move forward with contract manufacturing; marketing and distribution plans are in place.
Compliance	A state of operations that ensures activities are following documented protocols.
Computer Aided Design (CAD)	Software used by engineers to create precision drawings or technical illustrations. CAD can be used to create two-dimensional drawings or three-dimensional models.
Conformance	An affirmative indication that a product or service has met the requirements of a relevant specification, contract or regulation.
Continuous Improvement (CI)	The ongoing improvements of products, services or processes through incremental and breakthrough improvements.
Control chart	A chart with upper and lower control limits on which values of statistical measure for a series of samples are plotted.
Control limits	The natural boundaries of a process within specified confidence levels, expressed as the upper control limit (UCL) and the lower control limit (LCL).
Coordinate Measuring Machine (CMM)	A device that dimensionally measures 3-D products, tools and components with an accuracy approaching 0.0001 inches.
Core	A tube on which rolls are wound.
Corrective Action Preventive Action (CAPA)	The methodology used to define the root cause of a problem and correct it. A preventive action may be taken where appropriate to prevent the same issue from recurring in other identified areas. The effectiveness of the action taken must be verified to assure the root cause of the problem was actually corrected.
Corrective Action	The action to reduce or eliminate the cause of an identified problem.
Corrective Action Recommendation (CAR)	The full cycle corrective action tool that offers ease and simplicity for employee involvement in the corrective action/process improvement cycle.
Cosmeceutical	A marriage of cosmetics and pharmaceuticals. These are topically applied and contain ingredients that influence the biological function of the skin to improve the appearance by delivering nutrients necessary for healthy skin.
Cost of Goods Sold (COGS)	Also called Cost of Sales, COGS is the total direct expenses incurred in the production of a good. COGS includes the cost of materials used to make that good and the cost of labor to produce it. COGS does not include indirect expenses, like marketing, accounting, and shipping.
Cost of Quality (COQ)	Includes four elements: External Failure Cost: cost associated with defects found after the customer receives the product or service Internal Failure Cost: cost associated with defects found before the customer receives the product or service Inspection (appraisal) Cost: cost incurred to determine the degree of conformance to quality requirements (measuring, evaluating or auditing). Prevention Cost: cost incurred to prevent (keep failure and appraisal cost to a minimum) poor quality.
Cost-benefit analysis	An examination of the relationship between the monetary cost of implementing an improvement and the monetary value of the benefits achieved by the improvement, both within the same time period.
CP Index	A process capability measurement which determines whether the process variability can fit within the specification range. CP calculations are based on an estimation of the standard deviation.
Cpk Index	A process capability measurement which reflects the current process mean's proximity to either the upper specification limit or lower specification limit. Cpk calculations are based on an estimation of the standard deviation. The greater the Cpk value, the better.
Critical Control Point (CCP)	A step at which control can be applied and is essential; to prevent or eliminate a safety hazard or reduce it to an acceptable level.
Critical Quality Attribute (CQA) or Critical to Quality (CTQ)	The "key" measurable characteristics of a product or process whose performance parameters or specification limits must be met in order to satisfy pre-determined customer and regulatory requirements.
Current Good Manufacturing Practices (cGMP)	Current accepted standards of design, operation, practice and sanitization. The FDA is empowered to inspect manufacturing plants in which drugs are processed, manufactured, packaged and stored for compliance with these standards.
Cycle time	The elapsed time between the start and completion of a task or an entire process.
Defect	A product or service's nonfulfillment of an intended requirement or reasonable expectation for use, including safety considerations. Four classes of defects range in severity from Class 1 — very serious; leads directly to severe injury or catastrophic economic loss, to Class 4 — minor; is related to minor problems with respect to intended normal or reasonably foreseeable use.
Defective parts per million (DPM)	Total defects divided by total possible defects X 1,000,000 = DPM
Delamination	Separation of composite layers, either local or covering a wide area. Can occur in the cure or subsequent life.
Design for Six Sigma (DFSS), also (DMADV)	A data driven quality strategy for designing products and processes. It is an integral part of a Six Sigma quality initiative consisting of five interconnected phases: define, measure, analyze, design, and verify.
Design of Experiment (DOE)	A planned approach for determining cause and effect relationships. DOE studies can be applied to any process with measurable inputs and outputs.
Deviation	Any planned change from established plans, protocols or procedures; when an activity is performed in a manner that deviates from the established performance expectations.
Die	A device in converting machinery used for cutting a desired shape from a face material of a flexible material or for punching out shapes from the entire laminate or other material.
Die cut	The line of severance between a pressure sensitive label and its matrix by the cutting edge of a die.
DMAIC	A data driven quality strategy for improving processes and an integral part of Six Sigma quality initiative. Define, Measure, Analyze, Improve and Control.
Double coated	An adhesive or other coated material that is applied on both sides of the backing, which serves principally as a carrier for the adhesive or coated material.
Emboss	A raised design on a surface created by pressure of dies, rollers and printing presses.
Engineering Change Order (ECO)	A controlled form used to capture proposed engineering changes, discussion and resolution of the decision process prior to execution of the change(s).
Enhancer technology	Specifically for transdermal applications, any technology that enhances the ability for the drug molecule to penetrate through the skin. Examples include electricity (iontophoresis), ultrasound (phono- or sonophoresis), magnetism, and heat.
European Union (EU)	An intergovernmental and supranational union of 25 democratic member states. The European Union's activities cover all areas of public policy, from health and economic policy to foreign affairs and defense.
Extrusion	The process of taking 100% solids (usually in pellet form), and feeding them into an extruder. The pellets are heated and turned into a high viscosity molten material, which is then coated out of a slot die, onto a web.
Face material	Any paper, film, foil or other material suitable for converting into die cut parts. In the finished construction, this material is bonded to the adhesive layer and becomes the functional part of the construction (base material, facestock, etc).
Failure	The inability of an item, product or service to perform required functions on demand due to one or more defects.
Failure mode analysis (FMA)	A procedure to determine which malfunction symptoms appear immediately before or after a failure of a critical parameter in a system.
Failure mode effects analysis (FMEA)	A procedure in which each potential failure mode in every subitem of an item is analyzed to determine its effect on other subitems and on the required function of the item.
Feasibility	A step in the project plan for the team to evaluate the practicality or viability of the project, such as facility and resource needs, design reviews of the project, and quotes and execution of experimental orders.
First Article	The purpose of a first article procedure is to provide a method to verify and document that first run orders, used tooling, equipment, materials, and processes were properly designed, assembled, and verified to meet customer and Tapemark requirements.
Flexographic printing	A method of direct rotary printing using raised image printing plates, affixed to plate cylinders that transfer ink/coating to a substrate.
Flood coat	The coating of an entire surface with ink, adhesive, coating, etc.
Food and Drug Administration (FDA)	The US Department of Health and Human Services agency responsible for ensuring that food, drug, medical device, cosmetic, biologic, and vaccine products which reach the consumer are safe, wholesome and effective.
Four-color process	Printing with yellow, magenta, cyan and black, using screens to create all other colors.
Gauge Repeatability and Reproducibility (GR&R)	The evaluation of a gauging instrument's accuracy by determining whether the measurements taken with it are repeatable and reproducible.
Good Laboratory Practices (GLP)	Consists of 144 requirements that control the procedures and operations of toxicology laboratories, according to the American Society for Quality.
Good Manufacturing Practices (GMP)	A quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of pharmaceuticals, medical devices, food, etc, to ensure that products are safe, pure, and effective.
Green Belt (GB)	A business team leader who has been trained on the improvement methodology of Six Sigma and will lead a process improvement or quality improvement team within his or her organization.
Hazard Analysis and Critical Control Point (HACCP)	A quality management system for effectively and efficiently ensuring farm to table food safety in the United States. Regulations for various sectors are established by the U.S. Department of Agriculture and the FDA.
Heat Seal	The joining of two materials by application of heat and pressure.
Heat Seal Study (HSS)	A study to determine temperature and pressure parameters needed to yield optimal pouch seal characteristics.
High Performance Liquid Chromatography (HPLC)	An analytical method using a separation technique to create distinct bands which can then be profiled.
Histogram	A graphic summary of variation in a set of data. The pictorial nature of the histogram lets people see patterns that are difficult to detect in a simple table of numbers.
Hydrocolloid	An adhesive matrix formed by combining gums, synthetic rubber and/or polymers.
Hydrogel	A matrix that contains water, it can be manufactured from natural gums, synthetic polymers or both.
Hydrophilic	Having a strong attraction for water and able to spread it readily (opposite of hydrophobic). Examples include anti-fog masks and blood glucose strips.
Hydrophobic	Lacking attraction for water, repels fluid and forms a bead (opposite of hydrophilic). Examples include waxes and silicones.
Initiation	The phase in the Project Cycle when the team develops its Project Plan with elements addressing objectives, scope, assumptions, timeline, deliverables, team list, budget, risk assessment, and documentation.
Inspection	Measuring, examining, testing and gauging one or more characteristics of a product or service and comparing the results with specified requirements to determine whether conformity is achieved for each characteristic.
Installation Qualification (IQ)	Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered.
Interleave	To insert separate sheets of paper, etc between layers of other materials to facilitate handling or to prevent the layers from touching (slipsheet).
International Organization for Standardization (ISO)	A network of national standards institutes from 140 countries working in partnership with international organizations, governments, industry, business and consumer representatives to develop and publish international standards. Acts as a bridge between public and private sectors.
Investigational New Drug Application (IND)	An application to the FDA to begin clinical trials of a new drug or biologic on humans. The IND gives the plan for the study and contains formulation, manufacturing and animal test result information.
International Conference on Harmonisation (ICH)	The "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" is a joint initiative involving both regulators and research-based industry representatives of the European Union, Japan and the USA in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.
ISO 13485	An international standard that specifies requirements for a Quality Management System for an organization to provide medical devices and related services.
ISO 9001	An international standard that specifies requirements for a Quality Management System overseeing the production of a product or service and how it will be managed and reviewed.
Jidoka	The ability to manually or automatically shut down the production line when an abnormal situation occurs, so that bad parts are not produced.
Just-in-time (JIT) manufacturing	An optimal material requirement planning system for a manufacturing process in which there is little or no manufacturing material inventory on hand at the manufacturing site and little or no incoming inspection.
Kaizen	Gradual unending improvement by doing little things better and setting and achieving increasingly higher standards.
Kanban	A production-control system that uses cards or tickets as visual signals to trigger or control the flow of materials or parts during the manufacturing process.
Kiss cut	A die cutting operation which cuts through the face sheet to a liner but not through the liner.
Knife cut	Rectangular die cut parts in continuous form separated by a single knife cut to the liner across the web (butt cut).
Laminate	The material formed by bonding two or more materials together as in a pressure sensitive construction. To apply one layer of material over another.
Lean Manufacturing	Initiative focused on eliminating all waste in manufacturing processes. Principles of Lean include zero waiting time, zero inventory, scheduling, batch flow, line balancing and cutting actual process times.
Liner	The layer in the pressure sensitive construction that prevents one layer of materials from sticking to the next. The release liner also protects the material from contamination prior to application.
Lot	A definite quantity of some product manufactured under conditions of production that are considered uniform.
Master Batch Record (MBR)	A document used to record the production of a drug product.
Master History File (MHF)	A collection of documents used to record the development, qualification and/or validation of a manufacturing process.
Material Review Board (MRB)	Tapemark's cross-functional team that monitors and provides resources to the Non-Conformance Management system, elevating concerns as needed.
Material Review Report (MRR)	A report generated for a non-conformance event where product and/or material is or may be affected.
Matrix	The material of which the sample is composed or the substrate containing the analyte of interest.
Mean	A measure of central tendency; the arithmetic average of all measurements in a data set.
Mil	One thousandth of an inch.
MLI	Thousand Linear Inches.
Monomer	A small molecule that may become chemically bonded to other monomers to form a polymer. Hydrocarbon monomers, such as styrene and ethene form polymers used as plastics like polystyrene and polyethylene. The differences between monomers can affect properties such as solubility, flexibility, and strength.
MSI	Thousand Square Inches.
Net Promoter^® Score	The percentage of customers who are promoters (those who are highly likely to recommend your company or products), minus the percentage who are detractors (those who are less likely to recommend your company or products). Net Promoter Score = % of Promoters — % of Detractors ^® Satmetrix Systems, Inc., Bain & Company, and Fred Reichheld
New Drug Application (NDA)	After completing clinical trials on a new drug, a pharma company will file an application to the FDA for a license to market a new drug in the US.
Non-Conformance Management (NCM)	A system used to identify product or material that does not conform to specified requirements. This system provides a means of investigating the non-conformance, documenting what actions were taken to contain the problem or material, documenting the disposition of the product or material, a CAPA element to correct the situation and prevent recurrence, and a QA manager's signature indicating all items were completed satisfactorily.
Nutraceutical	Any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease.
Occupational Safety and Health Administration (OSHA)	The main federal agency to ensure worker safety and health in the United States by working with employers and employees to create better working environments.
Office of Combination Products (OCP)	An office of the FDA that ensures timely and effective pre-market review of combination products. Acts as a facilitator to the three FDA regulatory centers (CBER, CDER, and CDRH) by developing resources to streamline the regulatory process, reaching out to industry representatives, and maintaining a combination products tracking database to monitor the review process.
One-piece flow	The movement of products through the full manufacturing process one unit at a time, as opposed to batch processing.
Opacity	The measure of the amount of light that can pass through a material.
Operational Qualification (OQ)	Documented verification that the equipment related system or subsystem performs as intended throughout representative or anticipated operating ranges.
Original Equipment Manufacturer (OEM)	A company that uses product components from one or more other companies to build a product that it sells under its own company name and brand.
Over the counter (OTC)	A drug that can be purchased without a prescription.
Overlaminating	Application of a clear film to a web for the purpose of protection or to enhance graphic quality, usually done in-line on the press.
Pantone Matching System (PMS)	The brand name of a system for specifying colors – a standard in the printing industry. Property of Pantone, Inc.
Pareto chart	A graphical tool for ranking causes from most significant to least significant. It suggests most effects come from relatively few causes; that is, 80% of the effects come from 20% of the possible causes.
Pattern Coating	Coating applied in a pattern that does not completely cover the surface.
Permeability	The capability of being permeated; especially having pores or openings that permit liquids or gases to pass through.
Phase I	Initial safety studies in humans. May include as few as 10 subjects, often healthy volunteers, to determine side effects.
Phase II	Following Phase I, a drug is tested for efficacy typically in blind, randomized trials, in which a control group receives a placebo. Phase II trials typically involve 100-300 subjects with the disease or condition of interest, and testing may last from several months to two years.
Phase III	Following Phase II testing, a drug is tested in a large-scale setting (several hundred to several thousand patients) to determine effectiveness, benefits, and the range of possible adverse reactions. Most Phase III studies are randomized and double blind, and typically last several years. Usually two well-controlled studies are necessary to establish efficacy. Following successful Phase III studies, a drug company will file an NDA.
Phase IV	Following FDA approval and marketing, drug companies may conduct further studies on their products. Post-approval studies have several objectives, including comparing the drug with other drugs already in the market, monitoring the drug's long-term effectiveness, and determining additional potential uses for the drug.
Plan-Do-Check-Act (PDCA) cycle	AKA "Shewhart cycle." A four-step process for quality improvement. First, a plan to effect improvement is developed. Second, the plan is carried out, preferably on a small scale. Third, the effects of the plan are observed. Last, the results are studied to determine what was learned and what can be predicted.
Poka yoke	Japanese term which means mistake proofing.
Polycarbonate	A high clarity film having the versatility of acetate with the durability of polyester.
Polyester (unsaturated)	A product of an acid-glycol reaction commonly blended with a monomer to create a polymer resin.
Polyethylene	A tough, stretch plastic film having very good low temperature characteristics.
Polymer	Molecules consisting of structural units and a large number of repeating units connected by covalent chemical bonds.
Polypropylene	A thermoplastic material similar to polyethylene, but somewhat stiffer and softening at a higher temperature.
Polystyrene	An aromatic polymer made from the monomer styrene, a liquid hydrocarbon that is commercially manufactured from petroleum. At room temperature, polystyrene is normally a solid thermoplastic, but can be melted at higher temperature for molding or extrusion, then re-solidified.
PPK	A ratio of the distance between the process average and the closest specification limit, to three standard deviations of the long-term process variation. Uses the long-term variation in the process, as a result, serves as a good indicator of the process performance the customer is seeing.
Premarket Notification (PMN) also called 510(K)	Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device. The FDA will determine whether the device is equivalent to a device already placed into one of the three classification categories or to properly cllassify new devices.
Pressure sensitive label	A self-adhesive label construction composed of facestock, pressure sensitive adhesive and release liner.
Preventive action	Action taken to remove or improve a process to prevent potential future occurrences of a non-conformance.
Primary label	A label that acts as the main identification of a product.
Primary Mode of Action (PMOA)	Regulation that governs assignment of a new combination product to one of the three FDA regulatory centers for review: the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), or the Center for Devices and Radiological Health (CRDH). The FDA defines PMOA as the single mode of action of a combination product that provides the most important therapeutic action of the combination product. For example, if the PMOA of a drug-device combination product is attributed to the drug, it will be assigned to CDER for pre-market review.
Process	A set of interrelated work activities characterized by a set of specific inputs and value added tasks that make up a procedure for a set of specific outputs.
Process capability	How a process is running in relation to its specifications.
Process Capability Study (PCS)	A study to measure the capability of a specific piece of equipment or a process under specific operating conditions.
Process Development (PD)	A project phase where Tapemark defines and documents a specific manufacturing process for a specific customer product.
Process improvement	The application of the plan-do-check-act (PDCA) philosophy to processes to produce positive improvement and better meet the needs and expectations of customers.
Process map	A graphical representation of the process which is used to define bottlenecks.
Process Qualification (PQ)	Establishing documented evidence through appropriate testing that the finished product manufactured by a specific process meets all release requirements for functionality.
Process Validation (PV)	Establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.
Product Launch Team (PLT)	At Tapemark, a specialized team of experts that drives your product from development through commercial launch. Each of Tapemark's multiple PLT teams consists of a process engineer, a quality engineer, and a production operator.
Production Manufacturing Record (PMR)	A document used to record the production of a non-drug product.
Proof	A prototype of the printed job that is used for in-house quality control and/or for customer inspection and approval.
Quality Management System (QMS)	A formalized system that documents the structure, responsibilities and procedures required to achieve effective quality management.
Quality policy	The foundation of the company's Quality Management System as a commitment to achieve in the workplace. Tapemark’s Quality Policy is “Commitment to Excellence through Innovation, Design, and Continuous Improvement.”
Register	The fitting of two or more images or die cuts on top of each other in exact alignment.
Registration	In the manufacturing process, to ensure that two or more images or elements are exactly aligned.
Release	The force required to free or separate a pressure-sensitive material from its release liner.
Request for Designation (RFD)	A formal document submitted by the sponsors of a combination product providing information the FDA needs to determine the regulatory identity of the product as a drug, device, biologic, or combination product and assign the product to the appropriate center for review and regulation.
Resin	Typically is a polymer of plant or synthetic origin used as a filler, stabilizer, pigment or other component used principally in lacquers, varnishes, inks, adhesives or plastics. Can chemically interact with other components of the mixture.
Release liner	The component of the pressure sensitive stock which functions as a carrier for the die cut part. Prior to application, it protects the material and readily separates from the part immediately before the application to its substrate.
Root Cause Analysis (RCA)	Study of original reason for non-conformance with a process. When the root cause is removed or corrected, the non-conformance will be eliminated.
Rotary printing	A printing method in which impressions are curved around a cylinder so that the printing can be done on long continuous rolls of various substrates.
Scatter diagram	A graphical technique used to analyze the relationship between two variables.
Scrap	The material waste from a manufacturing process, such as the trim from a die cut.
Screen printing	AKA “silkscreening” or “serigraphy," a printmaking technique that traditionally creates a sharp-edged single-color image using a stencil.
Screening	The first phase of any project, a determination of how the project requirements match Tapemark capabilities and resources.
Self Wound	A material rolled up on itself with no additional liner; a coating is applied to the other side so that the roll will unroll.
Servo	A device where the control input is compared to the actual position. Any difference between the actual and desired values is used to drive the system to reduce the error.
Shelf life	Allowable storage time before a product must be used.
Six Sigma	A methodology that provides businesses with the tools to improve the capability of their business processes. This increase in performance and decrease in process variation leads to defect reduction and improvement of product quality.
Slit	To cut rolls of stock to specified widths; either rotary or stationary knives or blades are used with mechanical unwinding and rewinding devices.
Soluble film	A film that completely dissolves in the mouth, in a liquid, or upon heating, soluble film can carry an active, a flavor, a vitamin, or other ingredients.
Specialty pharma	Companies that market drugs for highly specific markets, in contrast with the broad approach of Big Pharma companies.
Splice	An area where tape has been used to attach two rolls of material together to form one continuous web.
Standard deviation	Most common measure of variability to determine the spread of data in relation to the mean.
Standard Operating Procedure (SOP)	A written document that details the routine procedures to be followed for a specific operation, analysis, or action.
Statistical Process Control (SPC)	A quality control system that continuously monitors production to identify and control the specific cause of variation in a process.
Substrate	The surface to which a die cut part is applied; converters also refer to the facestock being printed as the substrate.
Takt time	The total available work time per day (or per shift, or per other time period) divided by customer-demand requirements, for the same time period. Takt time sets the pace of production to match the rate of customer demand.
Tamper-evident label	A pressure sensitive construction made with a facestock having a low strength so that attempted removal of the label will result in destruction of the label and show evidence of tampering.
Therapeutic Goods Administration (TGA)	Australian regulatory agency for drugs and medical devices, similar to the FDA.
Thermoplastic	A material that is capable of softening or fusing when heated and of hardening again when cooled, while maintaining its properties through repeated heating and cooling cycles.
Tolerance	The maximum and minimum limit values a product may have and still meet customer requirements.
Topical	Pharmaceuticals, skin care, and cosmetic products that are applied to the skin in cream, lotion, or serum form.
Traceability	The ability to trace the history, application, service or location of a product by means of recorded identifications.
Transdermal	AKA “transdermal drug delivery." Supplying a medication in a form for absorption through the skin into the bloodstream. A transdermal patch may be passive, using simple diffusion across the skin, or active, using an enhancer technology to enable the drug molecules to penetrate the skin.
Transfer adhesive	Adhesive without a carrier coated or cast on a liner; it is applied to a surface; the end user removes the liner and the adhesive stays with the surface to which the transfer adhesive was attached.
Validation	The establishment of documented evidence that provides a high degree of assurance that a specific process or system will consistently yield a product meeting predetermined specifications and quality attributes.
Validation batches	Commercial scale batches that are manufactured consecutively in order to validate a process according to a validation protocol that was developed and authorized.
Value stream	All activities, both value added and nonvalue added, required to bring a product from raw material state into the hands of the customer, bring a customer requirement from order to delivery and bring a design from concept to launch.
Value stream mapping	A diagramming tool used to follow a product's production path from beginning to end. A visual representation of every process in the material and information flows is drawn, as well as a future state map of how value should flow.
Variation	A change in data, characteristic or function caused by one or more of four factors: special causes, common causes, tampering or structural variation.
Verification	Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
Viscosity	The property of resistance to flow in a fluid or semifluid, measured in centipoises. For example, honey and motor oil have a low viscosity (0-5,000 cps); molasses and many Rx and OTC ointments have medium viscosities (5,000-50,000 cps); peanut butter and window putty have high viscosities (greater than 50,000 cps).
Visual factory	An operational philosophy based on visual controls that enable an individual to immediately recognize the standard and any deviation from it. Visual factory eliminates waste through applications such as standardization, error proofing, quick changeover, and 5S. Common tools include shadow boards, color coding, information boards, horns, whistles, lights, inventory cards, etc.
Waiver	A written authorization to release a product that does not conform to the specified requirement.
Waste	Any activity that consumes resources and produces no added value to the product or service a customer receives.
Water soluble film	A film that completely dissolves in water, that can hold active pharmaceutical or cosmeceutical ingredients.
Web	A continuous sheet of thin material moving over rollers, generally for processing; stored and transported as coils.
Zero defects	A performance standard and methodology that states if people commit themselves to watching details and avoiding errors, they can move closer to the goal of zero.