Understanding quality control and compliance management

The more diverse the range of substrates, the more printing colors and processes used on a job, the more converting and finishing operations, then the more chance there is of something going wrong or of quality being compromized. Possible problems can range from:

• Poor register

• Color variation

• Picking

• Hickeys

• Poor die-cutting

• Poor transfer of foils

• Waste stripping problems

• Missing labels

• Poor slitting or scoring

• Bar code verification problems

• Adhesion problems

• Dispensing and application problems

The list could go on, but what can already be seen is that the range of things that can cause quality, accreditation or compliance problems in label and package printing is quite diverse. The more quality, accreditation or compliance variations or problems that a buyer can find, the more chance there is of the job or part of the job being rejected or a discount negotiated. It may even lead to the loss of accreditations or the supply contract.

Little wonder then, that the industry increasingly makes use of technology and systems that can pick-up print register or color problems, identify faults, verify barcodes, as well as check or inspect a whole range of other quality or possible standards variations. In addition, most of the leading brand owners and retail group will expect their label and pack suppliers to have some kind of quality control, quality management, quality audit, statistical process control  or compliance management system which, today, is increasingly being integrated into a sophisticated Management Information System (MIS) and automated workflow process. See Figure 6.1.

Having a system that provides a platform for quality, accreditation or compliance control, with detailed written procedures, recording and documentation of quality and performance issues, employee training, returns procedures and complaints logging has therefore become an important element in the management of label and package printing production information.

When problems or complaints arise there also needs to be a system of reporting and corrective actions, including the generation of management reports that enable faults or compliance trends to be ascertained and analyzed, perhaps leading to updating of quality control or compliance procedures or new employee quality training documentation.

Quality control systems may also store ISO, OSHA or other international or national Standards requirements and documentation that can be viewed or print generated by employees. Depending on the end-user sector, there may also be specific food, pharma, industrial regulations or compliance requirements. So what quality control, quality management, quality standards, compliance or accreditation schemes may label and package printers be working to?

Quality Control, also called Quality Management, Statistical Process Control (SPC) or Total Quality Management (TQM), are all management systems in which tests and/or inspections are applied at various stages during inventory management, during label or package printing production and during finishing to ensure that the end product meets pre-determined specifications and standards of quality and performance.

For the printers of pharmaceutical or food labels and packaging, there are also other quality or performance systems that they may have to work to:

FDA- or EU-compliant materials, Good manufacturing Practice (GMP) or Certificate of Compliance (CoC) for pharmaceutical products and medicines, and BRC Global Standards for the food and retail sector suppliers.

In the label and package printing industry, ISO 9000 has become the standard by which key label users, brand owners and buyers assess whether a system and procedures are in place to check and test incoming materials, or manage and control quality. More sophisticated quality management and quality control systems now being adopted by the label and package printing industry include Statistical Process Control, Total Quality Management and Six Sigma. See Figure 6.2.

All these quality systems and standards outlined in the flow chart, together with GMP, CoC and BRC Global Standards, are amplified in rather more detail as follows:

ISO 9000. Achieving certification to the internationally recognized quality management standard ISO 9000 has become the most common way for the label and package printing industry to introduce and implement a quality management system and demonstrate its commitment to quality. For many label and packaging industry suppliers and converters – as well as label buyers – it has become the expected standard.

Implementation of the BS EN ISO 9000 quality standard involves making a large number of small quality improvements across a wide range of business processes. Activities can be managed as a process, with each activity adding value to the last, all ultimately leading to customer satisfaction. Simple, user friendly, documentation can be created around a company’s existing business practices.

Statistical Process Control (SPC). A system by which printed label and pack quality results can be controlled, Statistical Process Control (more commonly known as Quality Control in the past), depends on the Quality Assurance functions of raw materials specifications and controls, printing process control, on acceptable standards and tolerances and on inspection. Each of these elements is further outlined below. Also Figure 6.3. 

• Specification and control of materials. Label printing uses a wide range of raw materials – label stock, ink, adhesives, varnishes, blankets, rollers, cutting dies, etc. – which should all ideally be controlled. Raw materials properties that can be measured, tested and controlled include the moisture content, brightness, gloss, absorption or picking of paper face materials; the tack, gloss, drying, color, yield or flow of inks or varnishes and Shore hardness of blankets, plates or rollers.

• Printing process control. The control of printing and processes can begin at the press fingerprinting stage, while color bars, targets, grayscales and other devices or instruments are used to provide objective measurements and numbers to control production. Instruments used for checking at various stages throughout the color origination, proofing, or printing process stages include spectro-photometers and densitometers.

• Standards and tolerances. Agreed standards and tolerances should preferably be established between the printer and the customer at the time the job specifications are finalized and accepted. These should aim to agree on tolerances for color variations, density variations, register variations, cutter tolerances, etc. and will vary according to the quality of the labels being produced.

• Inspection. The use of inspection procedures is essential in ensuring that SPC systems function properly and that materials control, process control and standards and tolerances are all functioning properly, ensuring that quality is improved and waste reduced.

Total Quality Management (TQM). The basis of TQM is that any product or service can be improved upon and that improvements reduce costs, provide better performance and give higher reliability. The approach of TQM is that any company can continuously improve the quality of its goods and services – manage its quality performance – through the participation of all levels of employees.

Developed in Japan after the Second World War, TQM’s management approach is aimed at long-term success through customer satisfaction. It is based on the participation of all employees within a company or group and on improving processes, products and services. Key elements within a TQM program include:

• The customer defines quality. His requirements are confirmed and any problems identified

• Senior management is responsible for taking the ‘quality’ lead in developing the company’s quality culture and strategy. All employees should be involved

• Quality is dependent on design and execution of all processes and systems to a high standard. It should be designed in from the beginning

• Error prevention should be built in to work processes and systems

• The ‘cost of quality’ or the ‘price of poor quality or non-performance’ should be calculated

• Problem solving techniques should be developed and implemented

• Continuous quality improvement is key to achieving higher quality standards

• Suppliers should be involved in the achievement of quality targets

• An ongoing aim should be to shorten response times

• Results should be communicated to employees

Label companies already working to ISO 9000 standards can move to higher levels of quality management through implementation of TQM
or Six Sigma.

Six Sigma. Six Sigma is a management methodology that enables businesses to achieve a goal of increasing profits, improving product quality and enhancing employee morale by eliminating waste, decreasing process variation and by identifying and reducing defects in manufacturing. It uses information and statistical analysis to improve a company’s operational performances, practices and systems by identifying and preventing ‘defects’ in manufacturing and related processes, enabling companies to both anticipate and exceed expectations.

More than just a quality system like ISO or TQM (Total Quality Management), Six Sigma is more about a philosophy or way of doing business in which defects are measured per million opportunities. Developed by Motorola, the Six Sigma methodology can be defined by reference to three levels: metric, methodology and philosophy.

• Metric. Commonly referred to as 3.4 Defects Per Million Opportunities (DPMO) provides a guide for considering at least three opportunities for a physical component.

• Methodology. The tools and roadmap that provide a structured method of solving problems.

• Philosophy. The route to reducing variation in a business by taking customer-focused, data driven decisions.

Six Sigma and TQM have many characteristics in common. They both focus on quality control, both address quality problems at their roots, both focus on solutions geared to the overall goal of the business, both rely on data as evidence, both require senior management to buy into the quality program and both aim for a lasting cultural change throughout the whole organization. Six Sigma however, is more quantitative and more pragmatic in its approach, using statistical analysis performance management. Six Sigma can be incorporated within an existing TQM environment.   

GOOD MANUFACTURING PRACTICE (GMP)

A GMP is a system that is used for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the initial starting materials, premises and equipment to the training and personal hygiene of staff.

Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

CERTIFICATE OF COMPLIANCE (COC)

A certificate of compliance (CoC) with the European Pharmacopoeia (also called CEP) is a document published by the EDQM (European Directorate for the quality of medicines) and which certifies that a substance with pharmaceutical purpose is well manufactured and controlled according to the equivalent monograph of the European Pharmacopoeia.

For a CEP, the manufacturer of a substance must file with the EDQM a technical file describing the product, its manufacturing, controls effectués… mode. It is assessed by members of the EDQM and the manufacturing site is inspected by one of the European agencies.

The advantage of the CEP is considered that the technical file of the substance was assessed and that on applications for authorizations to market multiple of a drug in Europe, it is more necessary that each national agency to do this assessment. Thus, CEP represents a kind of guarantee of quality and is therefore heavily used to active principles, especially if they are produced in some countries (such as the India or China) where quality standards differ from those in Europe.

In addition, by 2019 more than 80 per cent of global drug production will need to be complaint with regulations regarding unit identification.

BRC GLOBAL STANDARDS

BRC Global Standards is a leading safety and quality certification programme, used by over 23,000 certificated suppliers in 123 countries, with certification issued through a worldwide network of accredited certification bodies.

The Standards guarantee the standardization of quality, safety and operational criteria and ensure that manufacturers fulfil their legal obligations and provide protection for the end consumer. BRC Global Standards are now often a fundamental requirement of leading retailers.

MIS QUALITY CONTROL SYSTEMS

Starting with ISO 9000 as an internationally recognized quality management standard, it is possible to bolt on any or all of statistical process control, total quality management and Six Sigma systems to MIS systems to eventually rise to the highest levels of quality management and customer quality satisfaction.

Today, some of the leading MIS systems for label and package printing incorporate quality control modules and are able to integrate with Esko’s Automation Engine, as well as to presses, AVT inspection (see Figure 6.4) and ABG finishing equipment to automatically collect and analyze quality control data.

Esko’s Automation Engine serves as the heart of any size prepress production operation, enabling unparalleled workflow automation with rock-solid quality control. It comes with extensive business system integration capabilities and is highly scalable.

A job in Automation Engine represents a production order that organizes the data storage for the job but also the job’s metadata, its link to order ID, due date, customer info, Customer Service Representative contacts, etc.

Besides these administration attributes, a job can also contain the graphical specifications like barcode, inks, RIP options. This job information can be used in any workflow to take advantage of all the data that is already there, avoiding double entries.

Importantly, Automation Engine ensures increased efficiency and throughput and saves time and money. It is, by all standards, an exceptional answer to the daily challenges of print professionals who need to increase quality, reduce errors and drive cost out of the process.

It is also able to obtain information from external systems through SQL queries, XML or XMP data. This data populates job information and workflow parameters, using values that already exist. Examples include step and repeat data, barcodes, colors to be used, etc.

All job information is kept in an internal database, which can be archived for future use. Order administration systems can be linked through an MIS integration project, such as those undertaken by Cerm, Label Traxx, Tharstern, EFI, Global Vision and other suppliers. Information and data are centralized, which reduces operator intervention. Savings are achieved by measuring and billing consumables, proofs and plates.

The following paragraphs look at how some of these leading suppliers enhance Quality Control and Quality Assurance.

With the Label Traxx Quality Control Module, it is designed to assist in improving shop-wide quality control and the documentation of quality issues and costs. The Module incorporates five sections: Quality Procedures, Return Materials, Non-conforming materials, Complaints log and Documentation.

Put together these sections set out to improve shop-wide quality through the use of recommended quality procedures . embedded into the workflow  and configuring the interface for the capture storage, and display of recommended procedures for all production events. It will also capture and display customer-specific procedures. Importantly, it eliminates all of the Post-It notes, notebook and high-light forms that employees often forget to look at.

The recording of product returns with reason codes and corrective actions for reporting processes is also available within the Module, as well as the recording of non-conforming materials from vendors. It will also store and present OSHA and ISO requirements systematically.

Taking a different approach to Quality Control, Cerm consider ‘Quality’ as inherent to daily practice. Starting with quality at a GMP-certified customers first, they found that ‘quality is a work attitude,’ and not just a checklist.

The most important Quality Assurance features available in Cerm Software include:

• Approval procedures

• Project related screens

• Quality level management

• Quality groups

• Checklists

• Shopfloor line clearance

• Unique identification of raw materials and finished goods

• Sampling

• Traceability

• Registration and the following up of complaints.

An unlimited number of quality levels can be created in the software, containing rules for product approval, product ganging, product mixing and batch release. These can be set as a default per customer. It is also possible to impose an approval cycle for every new calculation, product, sales order and job, and these are created in the software.

Based on a database of of quality checks the series of checks that need to be executed . based on certain criteria (multiple appearance conditions) are defined. This forms the basis for the printing of a Quality checklist report per job. The document is to be filled out by operators and QC/QA throughout the flow.

For complaints, Cerm have developed what they call a ‘message’ module, which stores all communications . visit reports, customer communications, supplier communications, as well as ‘complaints’, production remarks, etc. that should be kept in a central database, although most of the time hidden.

These messages can be found with an easy ‘click’, and can contain questions about the cause of complaints (see Figure 6.5) and descriptions about the solution.

Cerm software is fully JDF/JMF compliant and integrates this functionality in the complete production flow. A JDF workflow reduces risks and mistakes by avoiding data re-entry and automating manual, repetitive steps from the production process. Therefore links exist with pre-press workflows (already mentioned above with the Esko Automation Engine), Printing-machines, Finishing-machines and Camera inspection systems (see AVT below).

Another MIS vendor with a Quality Management software solution is EFI. By setting up quality tests for specific raw materials, vendors, finished goods or customers, the EFI software can ensure that quality materials are being placed into inventory and that customers receive the products they expect. As quality issues arise, corrective action reports can be generated. And, through integration with DMI/Shop Floor Data Collection and scheduling, rework and schedule changes become less disruptive.

The latest version 4.1 of the EFI Packaging Suite, introduced at Labelexpo includes certified workflows geared toward real-world label and package converting environments. Each certified workflow combines the core EFI Radius ERP software with modular, integrated components from EFI’s portfolio, as well as with key third-party technologies, such as Esko’s Automation Engine.

One of the components in the Suite, the new Auto-Count 4D shop floor production intelligence platform, is making its worldwide debut. This innovative new component automatically collects accurate, up-to-the minute production data including counts, press status, speed and other critical information directly from production equipment in real-time. Through full plant visibility and data-driven reporting now in a browser based environment, packaging printers can have all of the information they need to make decisions in seconds.

Within the Tharstern Job Tracking Module there is the ability in their print ‘passport’ to track and record completion of required quality procedures during operations and ensure departmental compliance with quality assurance procedures e.g. operator confirms the imposition has been checked and approved. Operators can additionally add and edit their own notes on a job; these can even be emailed to a designated address. Milestone restrictions prevent jobs from being started if certain milestones have not been achieved, such as plates and material not ready.

OTHER QUALITY MANAGEMENT AND SOFTWARE SOLUTIONS

Outside of the main label and package printing MIS system, there are now an increasing number of print quality inspection, color, fault, barcode and other inspection solution available, both software and hardware . many of which are already being integrated with Esko’s Automation Engine and MIS systems. Some of the key solutions are briefly described below.

AVT recently premiered their Helios Turbo HD, which offers high definition resolution inspection along and across the web at full press and rewinder speeds – without sacrificing quality assurance and key applications such as in-line barcode verification.

To meet the specific needs of digital printing in the label and narrow web markets AVT introduced Helios D, an automatic, 100 per cent print inspection system. Based on AVT’s Helios product line, Helios D supports all stages of digital production workflow, including the identification of specific defects like missing nozzles, ink dripping spots, and color changes as soon as they occur. The result is reduced waste, enhanced production and comprehensive process monitoring, according to the company.

A new generation of AVT's in-line spectral measurement supporting nearly any application, including transparent flexible, paper, cartons, etc., SpectraLab II offers a compact design, advanced color workflow management and improved in-line to off-line measurement correlation. SpectraLab II also features enhanced color reporting capabilities, including real-time alerts to third-party reporting systems when colors shift out of tolerance.
The AVT systems extract business intelligence from the production floor and provide seamless connectivity to MIS and pre-press for optimized automated workflows.

Like some other quality control equipment and systems suppliers Global Vision has also embedded a Quality Control Platform within Esko’s Automation Engine so as to provide an all-in-one quality assurance solution that runs as a background process and results in an annotated and viewable design file within Automation Engine. This further enables rapid and systematic review of all detected packaging and labeling errors throughout the workflow, from upstream design to print.

Being able to process more jobs efficiently, while reducing the inherent risk of errors is critically important for label and package printer customers.

By integrating Global Vision’s Quality Control Platform into Automation Engine, it becomes possible to address the growing complexity of artwork quality assurance within a single solution that connects to other Esko applications in Esko Software Platform 16.

This approach enables everyone from graphic and print suppliers to brand owners to have access to automated quality control tools. Automated quality checking tools additionally enable label and package printers to process more jobs with the same people and yet with fewer errors. Being able to process more jobs efficiently, while reducing the inherent risk of errors is critically important today.

A ‘unique, highly adaptive’ new color management software solution for label and packaging applications is available from QuadTech. Without any hardware modifications to the press, QuadTech’s ColorTrack software integrates with ink formulation software to simplify workflow and reduce the number of ink corrections needed to achieve accurate, optimal color.

Meeting the demand for more in-line finishing and shorter runs has become easier with such integrated systems. Operators can control the entire production process from reel to reel. Miniature scanning heads recognize everything from standard colors to inks and coatings, invisible to the human eye, reducing job set-up time and waste.

It was because meeting the quality and consistency demands of brand owners had become increasingly difficult, that QuadTech, in partnership with ColorConsulting, developed what they describe as a ‘color expert in a box’ that automates the process of delivering absolute consistency from press-to-press, shift-to-shift, and plant-to-plant.

A wide range of on-screen dialogue boxes can be viewed in the system, including set-up screens, trends (see Figure 6.7.), LAB view, inspection
(Figure 6.8), etc.

With human color experts, according to QuadTech, three to five color corrections on start-up are typical for a new job – or even six to eight for difficult colors.

ColorTrack can achieve more accurate color in one or two corrections. ColorTrack claims to be the only software that offers this level of press-side connection between color measurement and ink management.

QuadTech’s Color Measurement with DeltaCam makes advanced, in-line spectral measurement affordable. For around the cost of a color register system, printers can utilize accurate, automated L*a*b* measurement on film, paper or board – ensuring that all printed product is within their customers’ color specifications.

Printers can reduce time and waste while maintaining color throughout the roll – without the need to wait for a roll change to measure with a handheld device. Operators can spot problems early and make corrections quickly, thus minimizing waste, customer complaints, and rebates.

Automatic and intelligent 100 per cent inspection solutions including the detection of defects such as streaks, hickeys, registration errors, unremoved matrix, missing labels, in-line absolute color measurement to ISO standards using the GV-Spectro in-line spectrophotometer - based system (Figure 6.10), and barcode verification are all now possible using the Guardian PQV flagship system (Figure 6.11) from PC Industries.

The system also offers automatic job changeover on the fly for digital printers to seamlessly continue 100 per cent inspection on press. In addition, automated remote job set-up off press help flexo printers reduce downtime when frequently changing jobs.

PC Industries also has a customizable system that verifies 1D and 2D barcode quality against ANSI/ISO standards. Their compliance package provides a secure login, reporting and documentation to allow pharmaceutical printers to fully comply with FDA CFR Part ll Compliance. Grading and verification can now be done at higher speeds while maintaining accuracy and minimum code size. The system also can verify human readable characters using OCR/OCV technology.

Another software company that has introduced a new software program for label printers is One Vision. Called DigiLabel, it is a comprehensive 2-in-1 system of automated label production which eases complex label workflows for digital label printers and combines print data optimization and label production planning. The benefits of the system include improved transparency, a safe production process and significant improvements in efficiency.

The software includes workflow solutions that enable the entire production workflow to be integrated, standardized and substantially automated. It also provides detailed quality control and optimization of print files and images using RIP and Inksave software, as well as individual solutions for the imposition of PDF files or flattening of transparencies – all done automatically.

DigiLabel makes use of this expertise in the entire production workflow: print data are automatically subjected to a quality control and then optimized. The automated production of die-cutting forms (see Figure 6.12) or laser-cutting configurations, standard cut lines, a white background and the automatic dispatch of a release PDF to the customer for approval saves labour time and staff resources.

The ColorCert Suite of software products from X-Rite provides real-time color and print quality process control and reporting to help packaging printers and converters better manage the complexities of CMYK, extended gamut, and spot color workflows, regardless of the printing process, substrate, or industry standard.

The ColorCert Suite consists of three modules specifically designed to help various members of the packaging workflow manage specifications and monitor quality control from the artwork to premedia to the ink room to the press room. The modules include:

• ColorCert Desktop Tools enable the accurate creation of color specifications and process controls at multiple points throughout the packaging workflow.

• ColorCert ScoreCard Server combines reporting and statistical process control to provide brands, packaging converters and premedia professionals with an easy-to-use dashboard for the monitoring of print quality by supplier, plant, machine, customer, work type, and more.

• ColorCert Repository Server, a secure, online asset management solution for storing, managing and deploying packaging color assets so that the most up-to-date assets are always being used and the packaging workflow is optimized.

• For brand owners, ColorCert provides an overview of supply chain performance to ensure accurate and consistent color across regional or global partners.

GLOBAL DRUG COMPLIANCE

The demand for unique product identification solutions, fueled by a global increase in regulations in the pharmaceutical industry, where more than 80 per cent of global drug production will need to be compliant with regulations regarding unit identification by 2019, has lead Adents and Microsoft to combine their expertise in unit identification and business intelligence to introduce a new Cloud platform named Adents Prodigi.

This new process, claimed to be the only Level 4 traceability solution (Figure 6.13) that can centrally manage regulatory requirements imposed on the pharmaceutical industry, as well as allow laboratories and CMOs to take advantage of the massive amounts of data generated during the serialization and Track and Trace process, offers extraordinary opportunities in terms of visibility on the life of products, but also represents a major challenge in terms of data management.

Adents Prodigi relies on advanced Microsoft Azure technologies and allows drug manufacturers to securely generate, exchange and control the huge amount of data created through unit identification.  The Adents Prodigi platform also integrates data analysis (including Microsoft Power BI) and machine learning tools, providing powerful analytics capabilities for these new sources of information.

In total, Adents Prodigi stands as an ideal solution to ensure compliance with new regulations while efficiently mining and utilizing new data to better manage production and distribution practices beyond regulatory compliance in terms of:

• Unit identification and traceability

• The fight against counterfeit medicines

• OEE and productivity monitoring across production sites

• Enhanced user experience and personalized communication

• Real-time data visualization and analysis

FINDING THE OPTIMUM SOLUTION

As can be seen from the MIS, software and hardware solutions set out in the preceding paragraphs, there is now a wide range of products that can be used to inspect, check and record almost any aspect of quality control, quality management and compliance. More come onto the market every year. Not all are fully integrated with MIS, but the list continues to grow.

Depending on the quality or compliance requirements demanded by customers, label and package printers can now find a solution or solutions for pretty well any quality-related application, market or customer. It is a question of looking to see what is available and test or trial as required so as to find the optimum solution.