Is your organization a part of the food chain?

The exploding and irreversible pace of globalization has brought in its wake changes in almost all areas of human activity. Goods and commodities that were once confined to one’s local area have now started reaching out to the unlikeliest corners of the world. One of the most active and important of such items to undergo a sea change in the way it is produced and consumed is food.

What we need every few hours, and was available and restricted to local use has now smashed boundaries. Finding a Mexican restaurant in Japan or a Chinese one in Canada is common. At the base of such drastic change in the food supply chain is the need for hygiene standards.

 

A single standard for global food?

In the last couple of decades or so since the phenomenal and hitherto unseen way in which the countries and markets of the world are getting closer to each other; the need for a uniform, global standard that regulates food standards has become a critical need. Again, this is a little problematic, because food, as we know, is very varied. It is as heterogeneous as mankind. So, is having a single Standard going to make sense?

It may not, but this does not obviate the need for a pan-food supply chain, global Standard for food safety. In fact, its need is greater than ever before now, with the changed times, when the boundaries of food movement have thinned down like never before. It is with the intention of standardizing standards across the food supply chain that ISO 22000 was born.

Certification

ISO left it to The Foundation for Food Safety Certification to establish strict systems for the effective implementation and rigorous auditing and maintenance of the standard combination. It is supported by the Confederation of the Food and Drink Industries of the European Union.

Being a certification scheme, The Food Safety System Certification 22000 or FSSC 22000 comprises ISO 22000 and ISO/TS 22002-1. It sets out a number of impartial Standards for manufacturers and others in the food supply chain to ensure quality standards. At its core, it insists on the PDCA (Plan, Do, Check, Act) methodology for the food supply chain. ISO 22000:2005 sets out the requirements for a food safety management system where any organization that is part of the food chain has to demonstrate its ability to control food safety hazards. This is to make sure that food is safe at the time it is being consumed by humans.  It applies to primary producers, processors, manufacturers, food and related service providers, and product suppliers.

References:

http://www.iso.org/iso/catalogue_detail?csnumber=35466

http://www.praxiom.com/iso-22000-intro.htm

http://arcms.ie/home/health-and-safety-systems/iso-22000-food-safety-management-system/

ISO 9001’s Process Approach to Quality Management

ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place.

It is all about process

Where this approach differs from the previous standard is that it improves upon it by offering an appreciably more generic structure that is readily adaptable, acceptable and applicable across virtually all sectors of the economy and sizes of organizations. Another area where it has made life easier is that it explains the requirements in plain and uncomplicated language that is shorn of Quality waffle and is relatable to people for whom it is meant –organizations’ line managers.

The customer is the focal point

The primary focus of ISO 9001:2000 is on improving the effectiveness of a QMS in order to heighten customer satisfaction by meeting customer requirements. It finds its complement in ISO 9004:2000, whose aim is improvement of the effectiveness and efficiency of a QMS by meeting interested party requirements.

Broadly, these are the steps in this methodology:

  • Step 1: Establish the responsibilities for managing the process;
  • Step 2: Define the process;
  • Step 3: Identify customer requirements;
  • Step 4: Establish measures of process performance;
  • Step 5: Compare process performance with customer requirements;
  • Step 6: Identify process improvement opportunities;
  • Step 7: Improve process performance

How is a QMS built?

  • A QMS comprises of four categories of interrelated processes, which make up the process approach:
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

References:

http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm

http://asq.org/quality-progress/2001/12/standards-outlook/the-process-approach-to-qms-in-iso-9001-and.html

GxP in Computer System Validation

GxP in Computer System Validation.

GxP (Good X Practice, where according to FDA compliance; X can mean Clinical, Laboratory, Manufacturing, Pharmaceutical, etc., and used according to the situation in which they occur) in Computer System Validation occupies a position of primacy in the field of technology because of various reasons. The important ones among these are the heavy use of software in a wide range of medical activities, and the changing nature of computer technology, which has a deep impact on pharmaceutical devices and related products. Companies in these businesses need to ensure that the best practices in software are implemented mainly to keep abreast of the developments.
GxP in Computer System Validation has developed at a rapid pace of late because of the trend to integrate electronic records into manufacturing practices. While this has led to huge improvements as far as the speed of processing records is concerned; it has also brought in its wake a few inevitable challenges. .

Critical aspects of GxP in Computer System Validation

GxP in Computer System Validation consists of at least three extremely important aspects. One, GxP in Computer System Validation in the life sciences industry is not a monolithic and inflexible set of instructions. It consists of various rules and applications that need to be applied by companies according to their need and requirements. In other words, a generalized, “one size fits all” approach does not work for GxP in Computer System Validation.

Secondly, these validation requirements need to be implemented at various stages of the Software Development Lifecycle (SDLC). This means that medical device, pharmaceutical, life sciences and other related industries need to comply with GxP validation at every stage of development of the product.

Also, it goes without saying that compliance is mandatory. Noncompliance invites penalties, because GxP requirements set out by the FDA have the effect of the law.

References:

http://www.stsv.com/pdfs/STS_CSV_article.pdf

http://www.21cfrpart11.com/files/library/miscellaneous/pics_guidance_jan01_draft.pdf

Six Systems Approach to Pharmaceutical cGMP Regulations

Six Systems Approach to Pharmaceutical cGMP Regulations.

The FDA has enacted several pharmaceutical cGMP regulations. These are key concepts that are critical to quality systems. Some of the concepts by which the FDA and other regulatory bodies ensure cGMP regulations are Quality, Quality by Design (QbD) and product development, Quality Risk Management, Corrective and Preventive Action (CAPA), Change Control, and the Six Systems Approach.

Of these, the six-system inspection approach is a systems-based approach to cGMP and is aimed at ensuring a robust quality system model for pharmaceutical products.

It consists of the following:

Quality System

• Facilities System
• Equipment System
• Materials System
• Production System
• Packaging & Labeling System

Quality system is the fulcrum

It needs to be borne in mind that the whole system centers round the organization’s quality system. The quality system is the pivot around which the systems approach revolves. It is the core and the very foundation for the manufacturing systems that are linked and function within it. 

The FDA does not consider the quality system as different or separate from the five elements. In this sense, it the quality system model may be considered the root from which the five elements branch out.

In other words, the five manufacturing systems integrate themselves them into the respective and appropriate sections of the model. The order of interplay and interdependence may vary slightly from one organization to another, but to those in the knowhow of the six-system inspection approach; the rationale by which the inter-relationship plays out is quite readily apparent.

State of control –the crux of the matter

The entire purpose of having a systems approach in which the systems are independent, yet integrate into each other seamlessly is that having a systems-based inspection compliance program ensures that the organization is equipped with the ability to assess whether each of the systems is in a state of control.

 References:

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM070337.pdf

Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com

SOX compliance training

SOX compliance training is a new requirement that publicly held companies and other CPA’s have to comply with. The SOX Act (Sarbanes Oxley Act) was a landmark legislation passed by the Congress in 2002. The primary purpose of this Act was to bring about greater accountability among businesses, especially publicly held companies and their auditors.

As a result of this legislation, organizations are required to bring in enhanced accountability by implementing the provisions of Act, which pertain to being in compliance with its provisions as set out in the Public Company Accounting Oversight Board (PCAOB), an SOX creation.

Compliance with relation to important company activities

Companies are now required to ensure compliance with the provisions of SOX in a number of ways. These relate to increased monitoring of the regulatory environment, scrutinizing prospective audit clients with a committee, and increasing staffing as workloads go by. The exact ways in which each organization needs to audit these call for sound SOX compliance training. It usually consists of training capsules that are measured in terms of hours spent on training staff on SOX compliance. These range from introductory five-hour packs to detailed 40-hour packs.

Aims of SOX compliance training

SOX compliance training is aimed at equipping companies, especially publicly held one, to implement the provisions of the SOX Act. This has to be carried out by a person appointed by the company. This person has to be a senior employee, preferably a senior manager, director or partner, who will monitor all changes in standards and implement them. Whenever there is a change in standards activity in the company, this person has to report this to PCAOB. The company has to also make sure that this person communicates these developments to the employees and gives them the information and support needed for ensuring compliance.

One of the principal aims of SOX compliance training is to make sure that the provisions of the SOX Act, which relate to items such as internal audit controls and increase in staffing needs are adhered to. SOX compliance training has to impart the method by which a company’s board rotates its partners, another important SOX requirement. There are different rotation plans for different kind of companies.

References:

http://www.journalofaccountancy.com/Issues/2004/Jun/TipsForTheSarbanesOxleyLearningCurve.htm

http://www.ehow.com/how_5955087_train-perform-sox-compliance-auditing.html?ref=Track2&utm_source=ask

http://www.grcg.com/sox-training/

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