0. Michael Schwarz EMEA Product Marketing

1. The target: Regulated industries
There are industries which are specifically regulated to ensure end- customers safety (protection of human health and life):
Food
Pharma

2. The Business opportunity
Regulations require efforts
which do not add value to the product.
Wonderware offers functionality which lower the cost in fulfilling regulation requirements

3. Regulations do traditionally exist
For both, Food and Pharma, so called Good Manufacturing Practices (GMP) exist
GMP define what should be done and what to take care of, when producing Food- and Pharmaceutical goods
GMP is a continuous updated state of the art definition

4. Pharma industries needs validation
Producers of Pharmaceutical products have to be certified that they follow GMP in production (valid for Europe)
Certification require Validation process (Audit)
Requires:
Plant specification under GMP
Build plant following spec
Testing to ensure production procedures follow spec and GMP
Document and ensure quality of production continuous

5. Food manufacturing Food manufacturing has to follow the GMP by law
Food manufacturing does not require any “validation” process
Food manufacturers are often requested by retailers (mostly supermarket chains) e.g. to ensure quality by ISO 9000 ff which requires a audit and certification

6. Critical issues showed weaknesses
Critical situations in Europe like the Mad Cow disease showed that it is very difficult to track products and materials along the supply Chain to identify risk to end users
Result:
Identification of effected products and non effected products not possible
Call back of all products
Scrap total production (goods)

7. The Consequence
To be able to ensure safety and identify effected products,
- retailer organizations
- and the European Community
started Food safety initiatives:

8. European Food safety initiatives
Public:
REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT
ESFA (European Food safty authority)
Private:
GFSI (Global Food Safty Initiative)
IFS (International Food Standard)
BRC (British Retailer Consortium) ( released GLOBAL STANDARD - FOOD ……
The food and even the fed market is facing requirements in certification from private organizations and law enforcement.
Reason for these initiatives are the critical situations in the last years where mad cow disease or Mouth and foot disease which showed up that the existing procedures for product traceability and the possibility to identify sources of material or ingriedience.
Motivation behind these initiatives are to be able to control such a critical situation or make sure that quality of delivered or sold products is ensured or contaminated or hazardous products can be identified and called back without affecting the brand or reputation.
(c) 2002 Invensys Systems, Inc.
9-Jan-18

9. EU Regulation No 178/2002 Some key elements …
feed manufacturers, farmers and food operators have the primary responsibility for food safety;
A successful food policy demands the traceability of feed and food and their ingredients.
(c) 2002 Invensys Systems, Inc.
9-Jan-18

10. Article 18 Traceability
1. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.

11. Article 18 Traceability
2. Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed.
To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.

12. Article 18 Traceability
3. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied.
This information shall be made available to the competent authorities on demand.

13. Traceability Document noteworthy events or action-
Document material consumption including material identification-
Documents critical quality values along the production process-
….for products and material. (single product or defined lot of products)

14. EU Regulation No 178/2002
REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January2002
laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
Existing food law principles and procedures shall be adapted as soon as possible and by 1 January 2007 at the latest in order to comply with Articles 5 to 10.
(c) 2002 Invensys Systems, Inc.
9-Jan-18

15. The business opportunity
Traceability required!
(product focused production process-, material consumption and quality measures documentation)
Cost effective solutions preferred:
high automation level possible, allowing cost savings by avoided call backs, and reduced documentation efforts…

16. The Wonderware offering
Wonderware’s FactorySuite offers cost effective solutions to automate product tracking and paperless documentation for regulated food environments.
FactorySuite covers functionality in continuous, Batch, Discrete and hybrid manufacturing processes.

17. Information Integration for traceability
SV Industrial Portal
ERP/SCM/CRM data
Order Number/Serial Number in Question
Bill-of-Materials, Routing for product
Product Structure
A2 Application Server
InSQL
QI Analyst
InBatch
InTrack
InTouch
Wonderware
Order Execution
Production Model used to control production
Genealogy
Consumption Records of part or lot
Production History
Complete as-built history and actual routing of part or lot
Event Data
Alarms, Failures, and Maintenance during production of part
Product Quality
Sample inspection and conformance data of part
Process Quality
SPC Alarms, shifts and trends during production of part
Process History
Trends/data of process conditions during production of part
(c) 2002 Invensys Systems, Inc.
9-Jan-18

18. Value using Wonderware Software
Secured Productivity and Profit by automation based traceability.
Lower costs and shorter implementation by leveraging standard software capabilities
Low cost device integration for data collection

19. Benefits of a Software solution
No manual operator procedure necessary
No paper based system
Reports on demand

20. Regulated Industries
Wonderware is committed to meeting the needs of regulated industries
Successful implemented functionality to lower the implementation and maintenance costs of applications in regulated environments (Food and Pharma)
Rügenfisch success story IFS (International Food Standard) certified

21. Dedicated Traceability offering
Wonderware will release a set of Objects and a database model for Traceability requirements
New offering
Industrial Application Server based
Targeted for the food market

22. Marketing activity example
Taken from “wired” a weekly newsletter send by Pantek UK

23. Powering intelligent plant decisions in real time.
(c) 2002 Invensys Systems, Inc.
9-Jan-18