Next Stop : a World of Possibilities
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TABLE OF CONTENTS
Disc Graphics, Inc. 10 Gilpin Avenue Hauppauge, NY 11788 T 631.300.1116 F 631.300.1388 discgraphics.com
March 2011 Greetings: We are again pleased to present this capabilities overview, illustrating our commitment to providing leading edge packaging solutions. DISC is an innovative packaging resource for a variety of markets, from personal care and pharmaceutical companies to major film studios. Over the last several decades we have built a reputation for producing packaging that resonates with consumers and aids in the product’s sale. Our customers have found we build more than creative packaging solutions, we build confidence. Through a close working relationship we are committed to truly understanding your unique situation. Our deeply experienced team will focus on solving your problems. You always know that we are dedicated to delivery, and will do whatever it takes to realize your objectives, your vision. We look forward to working with you and believe we can demonstrate what has made us the company of choice for many in your industry.
Sincerely,
Don Sinkin Donald Sinkin Chief Executive Officer
Specialty Packaging Solutions
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capabilities
Whatever your objective provides a single seamless way of getting you where you want to go.
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We provide you with a multitude of packaging options from standard print to unique multi-disc packaging Metro Tunnel | Washington, DC
capabilities
Who is We provide leading consumer-product companies with packaging that drives revenue, improves profit and fulfills their environmental objectives. Our packaging solutions exemplify innovation and creativity, and are delivered with exceptional service. It’s a blend of advanced technology, full service capabilities and market knowledge that makes us a world-class packaging solutions provider.
Background Started over 40-years ago, the company’s first product was record labels, also known as “disc labels”. Hence the name of the company, Disc Graphics refers to the labels in the middle of 33 1/3 LP’s. Records are long gone and our company has transformed itself into a packaging powerhouse leading the way in Pharmaceuticals, Personal Care, Beauty Products, and DVD’s. Over the years we have been recognized for packaging excellence and design, winning awards for “The Best Of The Best Workplaces In America” in the printing industry.
Robert Fatscher, MIS Manager; Ray Falco, Plant Manager; Richard Roth, Chief Strategy Officer; Bruno Foglia, VP Operations; Roy Wilson, Director Production; John Rebecchi, SVP Marketing; Peter Hires, Director Sales; Richard Legler, Director Quality Assurance; Stephen Frey, SVP Sales; Brian Hartigan, VP Finance; Diane Ferrante, Director Human Resources; Margaret Krumholz, President; Don Sinkin, CEO; Lori Maisano, Creative Services Manager
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Our Mission Statement
is a full service provider of high-quality creative packaging solutions and extraordinary customer service.
The
Team
Don Sinkin
Margaret Krumholz
CEO
President
Stephen Frey
John Rebecchi
SVP Sales
SVP Marketing
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capabilities
The
Team
Donald Mueller National Accounts Executive
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Bruno Foglia
Brian Hartigan
Vice President Operations
Vice President Finance
Richard Roth
Peter Hires
Chief Strategy Officer
Director Sales
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Ray Falco
Richard Legler
Plant Manager
Director Quality Assurance
Diane Ferrante
Lori Maisano
Director Human Resources
Creative Services Manager
Roy Wilson
Robert Fatscher
Director Production
MIS Manager
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capabilities
Primary Markets Entertainment • DVD and CD Packaging for major film studios, music companies, and game developers • Applications and Entertainment Software
Pharmaceutical • Branded and Private Label OTC drug companies, and contract manufacturers • Targeted Ethical and Medical Device Companies • Vitamin, Nutraceutical Products
Health and Beauty • Prestige Brands and Designer Brands (Cosmetic & Fragrance) • National Brand Personal Care Products • Cosmeceuticals (the marriage of cosmetics and pharmaceuticals)
Specialty Food Market Personal Consumer Electronics • Cameras • Cell Phones and Accessories
Luxury Goods • Liquor • Fragrances
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Products & Services Entertainment Media Packaging • DVD Wraps • CD/DVD Folders, inserts and booklets • Inkjet coding • DVD and CD multi-disc packaging • Custom Packaging
Paperboard Folding Cartons • SBS • CCNB, SUS • Specialty Stocks
Plastic-Transparent Packaging • Folding Boxes • Rigid Windows • Combination substrate packaging (Board and Plastic) • Lenticular Cells
Mini-Flute • E, F, N-Flute cartons • Specialty displays
Labels • Narrow web pressure sensitive • Paper, Foil, Static Cling • Specialty Stocks
Digital Printing • Short run folding cartons • Paper, paperboard, specialty stocks
Specialty Packaging • Setup boxes • Vacuum Forming • Custom Ancillary Items • Primary Packaging
Design Services • Creative, graphic and structural design team
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profiles
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Starting with a clear understanding of the customer’s requirements our designers, engineers and technicians bring vast skill, experience and enthusiasm to resolving the most challenging demands
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PROFILES
Flip Video Although the Flip Video Camera is heralded as a value priced alternative to complex and expensive video cameras, the package voices the message of high technology and upscale appeal. Both the Flip Camera and the packaging have a certain cachet…smart yet simple. • Outer carton is printed in 4-color process plus the Flip logo color + silver. The box is finished with a reticulating matte and spot gloss UV to enhance certain design elements. • Internal carton uses 20pt. SBS-C2S components for structural support and aesthetic appeal. The application of soft-touch coating gives all surfaces a non-abrasive and upscale feel.
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PROFILES
GAIAM/ Discovery Channel Shark Week Special O-Sleeve After presenting a wide range of creative concepts, including an actual mini wetsuit, the final result was an embossed holographic foil package with an additional special color to reinforce the image of the voracious Great White, which delivers a dramatic and dynamic result.
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Wild, Wild, West Collectors Set For Paramount Home Entertainment
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PROFILES
Oribe
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PROFILES
DVD & Plush Toy Package For Paramount Home Entertainment
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Charmed DVD Series
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PROFILES
Dimensional Direct Mail Folder For NX Stage NxStage launched a new home dialysis product which eliminates the need for trips to an outpatient center. The package reflects the value necessary to convince consumers to open the package and not be discarded with the jumble of direct mail bombarding most consumers. The dimensional folder is printed in 4-color process with our exclusive DISC-Cote, an inline matte and spot gloss UV. The spot gloss coating catches the eye and draws the viewer into the front panel image and key bullet points. We used 20Pt. SBS for the inside presentation piece to form a “dimensional folder” with a “frame-view” style center tray to hold the DVD. The 20Pt. SBS gives the tray sufficient strength to hold its structure and has a print friendly surface for the graphics
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PROFILES
Project: Make a counter display for the introduction of Plantscription, which according to Jane Lauder, was“…one of the most significant new product launches in the history of our brand.”
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Origins (an Estee Lauder brand) Origins is a plant-based line of skin care, makeup, bath/body and sensory therapy products.
Creative Ideas: Interactive components were introduced such as a book for browsing and a Petri dish containing a “skin-like” material. We recommended a hard cover book with film lamination to assure it would stand up to constant use in the field. The Petri dish holds a silicone based material colorized to give the look and subtle feel of natural looking skin. The face on the display illustrates a before and after look. We accentuated the consumer experience by applying a textured coating on the before side and soft-touch on the after application side; the consumer could actually feel the difference.
Construction: The main tray is a series of laminated solid bleached sulfate paperboard with cutouts for various components. The multilayered paperboard provides a rigid foundation that made it easy to produce different depths for the cutouts. Given the client request, we created two simple wooden legs tipped in a rubber material to support the display. The final deliverable was a fully assembled display packed in a custom shipper for delivery directly to counter.
Challenge: Create a display that is “interactive” so the consumer can touch and feel the display components. Unlike most retail displays for a product launch, this display is intended to have a long shelf life of more than 3 months. Additionally the client requested “the support underneath needs to be more “utilitarian” and not cosmetic…” The concepts of using wood, acrylic or metal were discussed. [profiles]
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PROFILES
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Lilly Pulitzer
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PROFILES
Kozy Shack In March 2009, Kozy Shack launched “The Quest for Real Ingredients” promotional campaign. The sweepstakes highlights “the great taste of the simple, honest ingredients that go into Kozy Shack pudding”…real stuff in every cup. The theme of the promotion is a quest, just like you would see in an adventure movie – “the most delicious adventure you’ll ever have.” What you search for is found inside the package – a unique 13-character code printed on every
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specially marked Kozy Shack sleeve that leads to free movie tickets and a chance to win a home theater system. After you purchase your pudding and find your code, you are directed to go to a special website to register for the home entertainment system and begin to enter your codes. You receive a free movie ticket after you successfully enter five (5) unique codes.
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Problem Kozy Shack was looking for a way to avoid tipping in a separate coded coupon into each package. Disc Graphics was asked to develop a secure and cost-effective packaging solution to
• Implement multi-layered check-and-balance system to account for materials processed, including independent audits.
imprint unique promotional codes in the inside of each sleeve
-Designed Area for Coded Spoilage
of specially marked Kozy Shack Pudding.
-Integrated Count Verification Points – Feed, Controller, Print Head, Scanner, Folder/Gluer and Palletization.
Solution • Design and implement a secured material handling and
• Provide customer-specific documentation for count verification, batch reconciliation and certified destruction of
distribution process including: code discs, electronic file
product, audited by an independent promotions management
transfers, controlled case packs, palletization and secured
and security consulting firms.
delivery of valued product • Investment in controller, code printer, and scanner installation on Folder/Gluer.
Results Kozy Shack achieved their control and cost objectives while
-Special Process Work Instructions
delivering an exciting promotion to the market.
-Core Team Training
Random security visits were made through the end of production and no security issues were identified. Waste Rate for imprinting and gluing operation was less than 0.25% with over 5,500,000 units produced. Code Reconciliation to finished product demonstrated less than 0.001% variation
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PROFILES
Soap & Paper Factory
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PROFILES
LNK International Background
Most Preferred
According to the EPA, Source Reduction and Reuse are highly effective and preferred methods to stop or minimize waste from entering into the solid-waste-streami. In reviewing their options, LNK International and their supply chain partner DISC felt the greatest opportunity to reduce waste, develop environmentally friendly alternatives and have the potential to save money was through source reduction and reuse.
Source Reduction & Reuse Recycling & Compositing Waste-to-energy Incineration and landfilling
Least Preferred
Source: EPA
Eco-Opportunity: OTC Pharmaceutical Folding Cartons Change the folding carton packaging to achieve a reduction in greenhouse gases, while reducing costs. The change cannot significantly alter the performance characteristics or aesthetics of the carton.
Solution: Source Reduction Source Reduction is part of a design strategy and is imbedded in the DISC package-design-review process. (DIAGRAM A) The EPA defines Source Reduction as “any change in the design, manufacture, purchase, or use of materials or products (including packaging) to reduce their amount or toxicity before they become municipal solid waste. Source reduction also refers to the reuse of products or materials”.ii In considering the environmental aspects of the design DISC provided a life-cycle assessment, alternative materials analysis, looked at preferred means to reach “wastei - Saphire, D., (1994). Delivering the goods: Benefits of reusable shipping containers. New York: Inform, Inc. (Inform, Inc.is an NGO focused on business and municipal practices).
ii - EPA, February 18th, (2009). Waste-Resource ConservationReduce, Reuse, Recycle. Retrieved March 11, 2009 from http://www.epa.gov/epawaste/conserve/rrr/reduce.htm
iii - Miller, C., (2008). Corrugated Boxes: Corrugated boxes are the biggest component of the waste stream by weight. Retrieved March 12, 2009 from http://wasteage.com
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minimization-objectives” and affect sustainable design. However, as illustrated in the graphic below, environmental design ideas are balanced with other aspects in a holistic approach to design strategy. After conducting a design review, which included testing various recycled substrates and nonpaperboard alternatives, the companies concluded that discgraphics.com
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converting the paperboard folding cartons from 16 pt. to 15 pt. SBS provided the greatest economic and environmental return
Package Design Review
while maintaining the brand, value perception, security, and performance characteristics of the carton. Benefits
COST
• Saved 175 Tons of paperboard in first year.
NEW PACKAGE DESIGN
• 307.4 Metric Tons of Carbon saved based on fewer trees cut down. • The change mitigates the impact of rising paper costs. • Extensive testing proved the change to 15 pt. met the performance requirements of the carton. Eco-Opportunity: Single Use Corrugated Shippers
VALUE PERCEPTION
SECURITY
PERFORMANCE
BRAND ENVIRONMENT
LNK and DISC through collaboration on green initiatives both
DIAGRAM A
recognized the waste created by using single-shipment corrugated containers. The delivery of folding cartons in corrugated shippers is a standard practice in most supply chains. Once used the corrugated is collapsed and generally
Even though the corrugated shipping containers are recyclable,
palletized for shipment to a recycler.
it still takes energy to transport the used containers, and to re-
Solution: Reusable Supply Chain Packaging
pulp and convert it back into a usable form. Since proximity and the ability to create a closed loop process is within reach, DISC
Corrugated shipping containers are so named for the fluted inner
and LNK developed a pilot program. Although early in the
layer that is sandwiched between layers of linerboard. Such
program, it has achieved expectations and it seems clear that a
containers are readily available, provide impact and
larger scale program will be implemented in the near future.
drop resistance, while still being light weight. However, they are generally single use and are a major contributor to the solid waste stream.
Conclusion: Collaboration is essential to achieve sustainable eco-friendly solutions To achieve your eco-objectives it is important to first look at
Corrugated Boxes Municipal Solid Waste (MSW) Facts iii
opportunities to eliminate or reduce potential waste created
Generated:
by your processes or supply chain. Although many packaging
• 31.4 million tons and 12.5% of the national solid waste stream by weight.
designers look at alternative materials, try beginning with putting
• 210 pounds per person per year.
less into your package. Source reduction is the preferred
• 32.6 million tons in 2007 according to industry data.
method to reduce waste. In addition, review the supply chain
Recycled:
and look for change opportunities that are often overlooked
• 22.6 million tons, for a 72.0% recycling rate.
because they are considered standard industry practices.
• 25.6 million tons (78.3%) in 2007 according to industry data.
Making eco-decisions requires the willingness to open conversations about something as common as corrugated
Based on the review of several environmental studies, the use of
containers and ask how we can manage this process differently
multi-delivery shipping cartons showed significant environmental
that will reduce waste and save money. This case study also
benefits. As an example, reusing single multi-delivery container
illustrates that supplier partnerships are key to achieving your
20-times would save 40 pounds of solid waste based on an
eco-objectives. Expand your resources by including suppliers
average 2-pound one-way corrugated container. Total use just
with proven track records using eco-design criteria. Remember,
for the LNK shipments, can yield an approximate potential saving
not all environmental alternatives cost more, and in today’s
of several hundred thousand pounds of waste per year.
economic environment making your processes greener without spending fields of it is the ultimate goal. [profiles]
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EQUIPMENT
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A stable of the latest equipment and continued investment in new technology keeps us ahead of the competition
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equipment
Packaging Group Printing Department 6 color 56” KBA Rapida Interstation UV Capabilities with Aqueous & UV Coating In-line with Close Loop Quality Control System 8 color 40” Heidelberg 102-CD with Cold Foil Application, UV and Aqueous Coating In-Line and the latest print-on-plastic technology 7 color 30” Komori Lithrone LSX-729 with In-Line Aqueous Coating. The press is equipped with the latest Job-Definition (JDF) digital workflow, In-Line roll-to-sheet capability and fully automatic plate changing system.
Ink and Coating Lab In-Plant Ink Lab with full proofing and mixing capabilities Digital Mixmaster with spectrophotometer capabilities
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Die Cutting
Bindery Department
Bobst – 142CER 56” High Speed Die Cutter with Blanking
2 CMP Hi-Die Automated Cutters
Bobst – 103E 28 x 40 High Speed Die Cutter with Stripping
Jagenberg 45” Computerized Guilotine Cutter
Bobst – 103ER 29 x 40 High Speed Die Cutter with Blanking
Polor Mohr 45” Programmable Computerized Guillotine Cutter
Bobst – 102BMA Stamping Press
Polor 62” Computerized Guillotine Cutter
Bobst – 142 Easy Press Pre-Make Ready System
Stahl 4 Plate Buckle Folder
Bobst – 103 Easy Press Pre-Make Ready System
Stahl 6 Plate Buckle Folder
Heidelberg – 18 x 23 Die Cutter
Stahl USA B-20 Folder 20.5” x 33”
Finishing – Gluing Department 32 x 45 Sakurai Silk Screen Press for U.V. Inks and Coatings
Pallet Film Wrapping Round Corner Machine 3 – Hole Drill Punch
Miehle 28 x 40 U.V. Coater Heidelberg Diana Pro 114 Folder & Gluer Vega 400 Straight Line Folder & Gluer 2 Vega 750 Straight Line Folder & Gluers International Right Angle Folder & Gluer International 6FX Straight Folder & Gluer International Speed King Straight Line Folder & Gluer Bobst Domino 100 Straight Line Kohlman 1050 42” Combination Window Placement and Patcher Longford Unit for In-Line Product Application 2 Quadrell Systems for Security Tag Application Plasma System to Facilitate Gluing of Difficult Substrates
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equipment
Electronic Pre-Press Full Service pre-press and desktop services Fuji Final Proof (Digital Proofer) Two (2) 1.3 TB File Server C1P3 Technology Plate Scanning System AGFA Avalon N16-50 Platesetter Kodak Approval Proofing System Full FTP Capabilities and state-of-the-art digital workflow Epson Stylus Pro 9900 Spectro Proofer
Structural Design 4 CAD-Cam Workstations Supported by CIMEX Software DATATECH DP53348 SampleMaker/Plotting table with Automatic Scoring Artios Package Design Software Mimaki CF-0912-2 Sample Maker/Plotting Table 2 – Esko Kongsberg XL20 Sample Maker/Plotting Table
Sheeter 2 – Maxon MSH 350-57” High Speed Sheeters with Double Roll Slitters
Quality Lab Test Equipment Micrometer Moisture Meter Spectro/Densitometer Code Verifier Gloss Meter 25x and 50x Proofing Viewers Microscope Coefficient of Friction (COF) Tester Ink/Varnish Adhesion Rub Tester Opening Force Gage Test Oven Lab Balance and Scales
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Digital Printing NexPress SE3000 Digital Production Color Press 5-over-5 color printing In-line Coating Kompac Kwik Off-line Coating Rated to print on nearly 600 substrates
GraphCorr Asitrade MPC Laminator – B,E, F and N Flute Sheet Size Max 63” X 65” Min 25 1⁄2” X 20” Roll to Roll Max 63” Wide X 72” Long Bobst SP142 Cer Die Cutter Sheet Size Max 55 7⁄8” X 40 1⁄8” Min 27 1⁄2” X 19 5⁄8”
International Speed Queen Max Length 40”– Max Width 46” Min Length 4 1⁄2” – Min Width 2 3⁄4” Staude Gladiators – (Windowing Machine) Max Blank Length 38” – Max Width 42” Min Blank Length 5” – Min Width 4” Max Window Length 24” – Max Width 28” Min Window Length 1” – Min Width 1”
Folder / Gluers International Speed King Max Length 52” – Max Width 51” Min Length 4 1⁄2” – Min Width 2 3⁄4”
Affiliates Color FX Sun Valley, California Cedar Graphics Hiawatha, Iowa
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equipment
Label Group
Printing Department 10 Color, 10.75” Nilpeter, Model FB-2500 Flexo Press with Interstation UV, Dual-Web Capabilities, Film Lamination, Turn Bar, Conveyor/Stacker and Video Web Inspection System. 8 Color, 10” Mark Andy, Model 2200 Flexo Press with In-line UV Coating, Dual-Web Capabilities, Film Lamination, Foil Stamping, Folding, Turn Bar, Conveyor/Stacker and Video Web Inspection System.
• In-House Ink Lab with Computerized System for Mixing, Matching and Inventory Control • Over 1100 Dies and 1000 Print Cylinders • Over 75 Anilox Rollers
8 Color, 7” Mark Andy, Model 2200 Flexo Press with In-line UV Coating, Film Lamination, Turn Bar, Conveyor/Stacker and video Web Inspection System.
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• Ultrasonic Anilox Cleaners, Stratix Examiner Elite Code Verification Unit with Printer, X-Rite SpectroDensitometer • Dual Camera Precision Plate Mounting System
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Rewinding and Inspection Rotoflex VSI33o Slitter/Rewind/Inspection/ Arpeco Slitter/Rewind/Inspection/ 2-Web Technique Table Top/ Slitter/Rewind/Inspection Stations
Sequential Numbering Videojet XL High Speed Printer Markem-Imaje 9040 Ink Jet Printing System
Electronic Prepress and Plating (Digital Workflow) Xanté, OpenRIP Flexo 7.0 Flexo Workflow Software Freeform Ganging Speeds Production Latest ADOBE PDF Print Machine (APPE) Integrated PANTONE® Color Libraries Halftone Post-Processing Eliminates “Dirty Dots” Color Management & Viewing Advancements Flexo CTP: Dupont Cyrel “FAST” 1000TD With Esko CD 1 Spark 4835 Platesetter (Non-solvent based eco-friendly platesetting system) Kodak Approval Proofing System • Full FTP capabilities and state-of-the-art digital workflow
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quality management
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Continuous Quality Improvement is the engine that drives our leadership position in today’s market
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quality management
Quality Management System The DISC Quality Management System (DGI-QMS) is designed to provide a basis to continually improve product quality and customer satisfaction. The DGI-QMS is based on the eight fundamental quality management principals identified in ISO 9001:200: • Customer focus • Leadership • Involvement of People • Process approach (Quality System Effectiveness) • Systems Approach (Management) • Continual Improvement • Factual Approach (Decision Making) • Mutually Beneficial Supplier Relationships
Quality Policy Statement
DISC is committed to delivering high-quality creative packaging solutions and extraordinary customer service while inspiring individual and corporate excellence. The DGI-QMS has also been constructed to comply with customer compliance related to the applicable regulations and requirements for “Good Manufacturing Practices” (GMP) as set forth in 21 code of Federal Regulations, Parts 111, 210 and 211. The FDA has current Good Manufacturing Practices that include the “manufacture, processing, packaging or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products”1. Therefore, the processes and procedures utilized by Disc Graphics conform to pharmaceutical and other FDA-Regulated customer requirements. According to the FDA, “manufacturing according to the cGMP means that the manufacturing process incorporates a set of controls in the design and production processes to assure a quality finished product… A critical aspect of cGMP is achieving control over manufacturing processes. Controls are necessary
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to ensure that you manufacture what you intend so that the characteristics and/or attributes desired in a final product will be consistently and reliably achieved.�2
Management Review Process Corrective Action SOP 8.5.2 describes the corrective action process of
The essence of cGMP is product integrity, accountability and batch
QMS. Corrective action is required when significant or
control. Our processes account for the production requirements
recurring nonconformities are identified. The purpose of the
that all components are traceable throughout the manufacturing
corrective action process is to eliminate the cause of these
process. Waste control, sanitation, maintenance and
nonconformities and prevent their recurrence. SOP 8.5.2
environmental controls are also key elements of the DGI-QMS.
describes the process for:
Management Commitment
a) Reviewing nonconformities and customer complaints
The senior management team at Disc Graphics is committed to the development, implementation, and continual improvement of an effective quality management system. This commitment is demonstrated by ensuring the organization is focused on understanding and meeting customer statutory and regulatory requirements, maintaining and reviewing a quality system that communicates a commitment to quality, customers and continual improvement. The DISC Quality Policy Statement is posted in various locations throughout the facility, as well as the measurable quality objectives that are aligned with customer requirements.
b) Determining cause of nonconformities c) Evaluating the need for action to correct and prevent recurrence d) Determining responsibility for initiating and implementing corrective action e) Documenting and reviewing the effectiveness of corrective action f) Communicating corrective action with the customer
Preventive Action The preventive action process described in SOP 8.5.3 is designed to identity opportunities for improvement to make the
Responsibility, Authority and Communication The Director of Quality Assurance has been designated the Management Representative for the QMS and has the authority to: a) Ensure that processes needed for the QMS are established, implemented and maintained b) Report to senior management on the performance of the QMS and any need for improvement c) Ensure the promotion of awareness of customer requirements throughout the organization d) Chair the Management Review of the QMS
QMS more robust to potential nonconformities. The purpose of the preventive action process is to identify and eliminate the potential cause of nonconformities and prevent their occurrence. SOP 8.5.3 describes the process for: a) Reviewing nonconformities and customer complaints b) Identifying and determining potential nonconformities c) Evaluating the need for action to prevent occurrence d) Determining responsibility for initiating and implementing preventive action e) Documenting and reviewing the effectiveness of preventive action
e) Review the DISC Quality Policy Statement with all employees on a periodic basis
1 21
Code of Federal Regulations, Section 210.3, Definitions. Retrieved June 9, 2006 from http://www.fda.gov/cder/dmpq/cgmpregs.htm
2 21
Code of Federal Regulations, part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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quality management
Design and Development
h) Proper material handling, storage and packaging techniques to
SOP 7.3 describes the controls associated with input, output,
i) Line clearance, product separation and segregation procedures
prevent damage, mixing and deterioration
review, verification and validation activities that support the design and development of packaging solutions.
Process owners are responsible for ensuing work performed with the proper equipment and monitoring and measuring
• Design inputs are reviews and include as appropriate:
devices are available as needed to ensure acceptable
a) Functional and performance requirements
product quality.
b) Applications statutory and regulatory requirements c) Information from previous designs where applicable d) Other essential design and development requirements • Design outputs (design samples, templates, etc.) are approved prior to release and are verified to ensure they meet the input requirements. Outputs of the design and development process include: a) appropriate information for purchasing and production b) product acceptance criteria c) product characteristics that are essential for safe and proper use.
Control of Monitoring & Measuring Devices SOP 7.6 describes the process for controlling monitoring and measuring devices. This process ensures the monitoring and measuring equipment used to verify product specifications is accurate and there is a defined protocol when equipment is found to be out of allowable tolerances. This process ensures calibration has been documented and is performed with standards traceable to NIST or other recognized international or industry standards.
Measurement, Analysis & Improvement
Planned design reviews evaluate how well the design meets the
DISC utilizes various methodologies for monitoring, measuring,
customer requirements and identify potential problems and
analyzing and improving processes needed to demonstrate the
preventive actions needed to ensure acceptable product quality.
conformity of our products and ensure the effectiveness and continual improvement of the QMS. These techniques include,
Production and Process Planning SOP 7.5 describes the requirements that ensure production
but are not limited to: process monitoring, in-process inspection, auditing and process improvement teams.
is executed under the following controlled conditions:
Control of Nonconforming Product
a) How information is provided concerning product characteristics
SOP 8.3 describes the process and procedure for ensuring that
b) How work is to be communicated and performed
product which does not conform to product requirements is
c) Release, delivery and post-delivery activities
identified and controlled to prevent its unintended use or
d) How customer property is identified and controlled
delivery. Nonconforming product is effectively controlled by
e) How processes that cannot be verified by monitoring or
initiating one or more of the following actions:
measurement are validated to determine the capability of
• Identifying and contain detected nonconforming product
the processes to achieve planned results and how records
• Segregate nonconforming product
are maintained
• Assesses and corrects the nonconformity
f) Techniques for determining product status g) Techniques for identifying, controlling and recording
• Re-inspect and verify product conformance to specification and acceptable quality limits
product traceability
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• Initiate appropriate recall protocol if nonconforming product is detected after delivery • Authorize use, release or acceptance under concession by relevant authority Quality Assurance maintains records of product nonconformance and subsequent actions taken to control its release.
applicable governmental regulations and humanity and temperature levels are maintained in critical areas of the facility in order to facilitate manufacturing processes.
Customer Satisfaction A key measurement of the performance of the quality management system is information relating to customer perception of how well we meet customer requirements.
Training
This information is at a minimum reviewed quarterly during
SOP 6.2 requires job analysis to be conducted and maintained
customer complaints is described in WI 8.2.1.1.
for all jobs that fall within the scope o the QMS. Department managers are responsible for determining competency requirements including education, experience and training for the various jobs in their areas of responsibility. Supervisors are responsible for providing training and updating the employee training record when a new or revised process or procedure is released. Individual managers are responsible for the competency of their employees. All training and competency evaluations are documented by department managers and are
Management Review. The process for handling and resolving
Certifications ISO 9001:2008 Registrar: Def Norske Veritas (DNV) Certificate No.: CERT-07 480-2004-AQ-HOU-ANAB Chain of Custody (COC): Forest Stewardship Council (FSC) Registrar: SGS Certificate No.: SGS-COC-003430
filed in the employee’s personal folder.
Environmental Controls SOP 6.4 identifies the policies and processes for controlling contamination by organic waste and vermin during the manufacturing process. In order to prevent the possibility of organic waste contaminating finished product, employees are prohibited from having food or drink or eating or drinking at work stations in any manufacturing area. Area supervisors are responsible for ensuring these areas are maintained at acceptable housekeeping standards. A pest control company is contracted to perform periodic inspections and take action to prevent and eliminate any vermin found in the facility. Trash is removed from the facility in a timely manner and all spills are contained in order to prevent a condition that may attract or breed vermin. Handling and disposal of all manufacturing waste is in compliance with all
[quality management]
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Disc Graphics, Inc. 10 Gilpin Avenue, Hauppauge, NY 11788 631.234.1400 discgraphics.com NEW YORK • CALIFORNIA • NEW JERSEY