Wednesday, December 30, 2015

Auditing Process and Practical Auditing - II

The Audit
The audit is a process which consists of 4 interconnected steps; that initiates, conduct and evaluate before reporting to the concerned parties.

The 4 Phases of an Audit
Audit preparation – Audit preparation consists of everything that is done in advance by interested parties, such as the auditor, the lead auditor, the client, and the audit program manager, to ensure that the audit complies with the client’s objective. The preparation stage of an audit begins with the decision to conduct the audit. Preparation ends when the audit itself begins.

Audit performance – The performance phase of an audit is often called the fieldwork, which is the data-gathering portion of the audit and covers the time period from arrival at the audit location up to the exit meeting. It consists of activities including on-site audit management, meeting with the auditee, understanding the process and system controls and verifying that these controls work, communicating among team members, and communicating with the auditee.

Audit reporting – The purpose of the audit report is to communicate the results of the investigation. The report should provide correct and clear data that will be effective as a management aid in addressing important organizational issues where audit process may end when the report is issued by the lead auditor or after follow-up actions are completed.

Audit follow-up and closure – According to ISO 19011, clause 6.6,; “The audit is completed when all the planned audit activities have been carried out, or otherwise agreed with the audit client.” Clause 6.7 of ISO 19011 continues by stating that verification of follow-up actions may be part of a subsequent audit.

However, requests for correction of nonconformities or findings are very common, where corrective action is the action taken to eliminate causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence (reactive). Corrective action is about eliminating the causes of problems and not just following a series of problem-solving steps, where preventive action is an action taken to eliminate the causes of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence (proactive).

Performance versus Compliance/Conformance audits
There are various terms to describe an audit purpose beyond compliance and conformance: value-added assessments, management audits, added value auditing, and continual improvement assessment are some of the very common terms where purpose of these audits goes beyond traditional compliance and conformance audits. The audit purpose relates to organization performance, where the audit, that determine compliance and conformance are not focused on good or poor performance. Yet performance is an important concern for most organizations. A key difference between compliance conformance/audits and audits designed to promote improvement is the collection of audit evidence related to organization performance versus evidence to verify conformance or compliance to a standard or procedure. An organization may conform to its procedures for taking orders, but if every order is subsequently changed two or three times, management may have cause for concern and want to rectify the inefficiency.

Follow-up Audit
A product, process, or system audit may have findings that require correction and corrective action. Since most corrective actions cannot be performed at the time of the audit, the auditor may require a follow-up audit to verify that corrections were made and corrective actions were taken. Due to the high cost of a single-purpose follow-up audit, it is normally combined with the next scheduled audit of the area. However, this decision should be based on the importance and risk of the finding. An organization may also conduct follow-up audits to verify preventive actions which were taken as a result of performance issues that may be reported as opportunities for improvement or sometimes organizations may forward identified performance issues to management for follow-up.

The Auditor’s Concerns
What types of records will an internal auditor review?
Policies and Procedures (SOPs)
Records
Observation of the processes within the scope of the audit
Training records (Anything that can prove ongoing systems are operating as intended and as required)
Health status records

What types of records will an internal auditor not review?
Personnel records
Disciplinary records
Human resource records specific to employees
Accounting records not under the quality/safety management system


What is the role of an internal auditor?
A catalyst
An interface between groups
An advisor
A reporter of facts
An internal auditor can become a type of internal consultant for the organization

Why External/Second Party Audits are Important? 
One organization auditing another with which it either has, or is going to have, a contract or agreement for the supply of goods or services.
Comprehensive evaluation performed by a customer to help ensure that the supplier is operating under a state of control for periodic auditing of annually or biennially.
These audits are performed to help ensure the proper capabilities and quality systems are in place which promotes understanding of expectations of the customer.
This provides an avenue of quality/safety performance information transfer between the supplier and customer, which builds customer confidence regarding compliance to regulations/standards as a good business practice.

What an external auditor will review (not all inclusive)?
Quality manual or performance improvement plan
Organizational charts
Registrations/licenses/accreditations
Policies and procedures (sops)
Records
Observation of the processes within the scope of the audit
Training records
Usually a high level sampling of the above documents

What an external auditor will not review?
Internal audit reports
Other organizations audit reports
Personnel records
Health records
Disciplinary records
Human Resource records specific to employees
Accounting records not under the quality management system
May inquire about last FDA audit findings

Why External/Third Party Audits are Important? 
Verify compliance to specific regulations or standards 
Required by law:  FDA, State, OSHA, EPA, Financial 
Voluntary: AATB, ISO, AOPO, EBAA

What a Third Party Auditor will review (not all inclusive)?
Food safety/Quality Manual or Performance Improvement Plan
Organizational Charts
Records including training records
Observation of the processes within the scope of the audit can review the schedules and procedures for management review and for internal and external (audits usually a high level sampling of the above documents)
All the critical control points and OPRPs
HACCP studies
Previous Internal audit files
NCR/CAR reports
Continuous Improvements
Internal or external audit reports
Management review outputs  


 The external auditors (second/third) as well as internal audits will consider following areas for their audit mandates   

System – A review of the theory behind the processes (can be a food safety/quality system
audit) and a high level review of an organizations systems; document control, training programs, control of measurement and test equipment which usually spans multiple departments and includes processes.
  
Process – The practices of the organization, the flow and inter-relationships within systems always a part of a systems audit but process audits can be performed separately. This is where the organizations procedures are validated. How effective are the communications between processes and the systems are also very important.
  
Product – The results of the processes; assessment of the final product evaluated against the requirements (specs, inspection records, procedural requirements) which could be final inspection. There can be a complete breakdown of the final product that verifies the paperwork trail, inspection and test results, and that the specs were all met this can be used internally but often used in a Second Party audit of a supplier of specific products.

Documentation – Paper trail of compliance or documented overview of organizations systems. Paper audit or desktop audit as well as survey can be used to pre-qualify a supplier but best to perform an on-site prior to accepting product

What a Third Party Auditor will not review?
Personnel records
Health records
Disciplinary records
Human Resource records specific to employees
Accounting records not under the quality management system

Internal audits
When developing your audit schedule base the need on risk and do not just try to comply with the requirements. The risk can be further categorized as health risk, process risk, business risk and compliance risk.

Tips on how to prepare for the audit
Assure your critical documents reflex current practices within the organization
Assure your SOPs are developed, reviewed, approved, revised and archived
Documented procedures for all core requirements and critical processes
Corrective and preventative action mechanisms with prompt and effective responses
Training and education of personnel – current and documented
Environmental monitoring – current and complete
Record maintenance – up to date
Product deviation investigation – system in place
Audit program – continuous

Food Safety Auditing
One of the keys to any successful food safety auditing program is to know who you are buying from. In order to do this, food suppliers' facilities should be inspected on a regular basis either by your own auditors, approved 3rd party auditors or combinations of the two methods which are external audits. This must be done in a comprehensive but cost effective manner. All of the supplier’s facilities and processes, as well as those vendors and suppliers who service your food material, warehousing and transportations needs should be evaluated on a regular basis by buyer’s auditors or third party hired auditors.
However, adequate and up to date standards and requirements can only be verified through approved 3rd party audits. Combinations of these two methods are the best way to protect you against unexpected safety or quality incidents. At the same time, the process must be accomplished in a comprehensive, yet cost effective manner where buyer needs to develop, implement and validate/verify supplier-auditing programs. Supplier auditing optimization (review of current programs and recommendations for modifications, if needed) can be carried out by developing and helping to implement new programs (includes guidelines for selecting third party auditors, role of consumer complaint monitoring and cost implications to you and your suppliers) in addition conducting triage audits in cases where recalls or consumer complaints are involved will be very important which can be further improved by developing risk-based auditing instruments

Third Party Audits and Food Safety Inspection

Third party audits provide a credible verification of system to the entire food processing industry including retail environments, meat, fish, and poultry, vegetable as well as produce suppliers. Having a HACCP plan in place is often a first step to a successful food safety program, but it is not entirely enough to ensure that food safety standards are being adhered to on a consistent basis. Purchasing food products from an outside source may directly impact on the success of your business, if your vendor does not adhere to the same strict sanitation standards as maintained in your operations.

Tuesday, December 29, 2015

What is Quality and Food Safety Auditing?

Auditing
Auditing is a systematic, independent and documented process for obtaining audit evidence (records, statements of fact or other information which are relevant and verifiable) and evaluating it objectively to determine the extent to which the audit criteria such as set of policies, procedures or requirements are fulfilled. Audit evidence is used to evaluate how well audit criteria are being met. Audits must be objective, impartial, and independent and the audit process must be both systematic and documented. Several audit methods may be employed to achieve the audit purpose. There are three discrete types of audits: product (which includes services), process and system. However, other methods such as a desk or document review audit may be employed independently or in support of the three general types of audits. Some audits are named according to their purpose or scope. The scope of a department or function audit is a particular department or function. The purpose of a management audit relates to management interests such as assessment of area performance or efficiency. An audit may also be classified as internal or external, depending on the interrelationships among participants.



Product audit – is an examination of a particular product or service (hardware, processed material, software) to evaluate whether it conforms to requirements (that is, specifications, performance standards, and customer requirements).

Process audit – A verification that processes are working within established limits. It evaluates an operation or method against predetermined instructions or standards to measure conformance to these standards and the effectiveness of the instructions. Such an audit may: Check conformance to defined requirements such as time, accuracy, temperature, pressure, composition, responsiveness, amperage, and component mixture. Examine the resources (equipment, materials, people) applied to transform the inputs into outputs, the environment, the methods (procedures, instructions) followed, and the measures collected to determine process performance. Check the adequacy and effectiveness of the process controls established by procedures, work instructions, flowcharts, and training and process specifications.

System audit – An audit conducted on a management system. It can be described as a documented activity performed to verify, by examination and evaluation of objective evidence, that applicable elements of the system are appropriate and effective and have been developed, documented, and implemented in accordance and in conjunction with specified requirements. I.e. a quality management system audit evaluates an existing quality program to determine its conformance to company policies, contract commitments, and regulatory requirements.

There are three types of audits: first-party, second-party and third-party. First-party audits are internal audits. Second and third party audits are external audits. Organizations use first party audits to audit themselves. First party audits are used to confirm or improve the effectiveness of management systems. They're also used to declare that an organization complies with an ISO standard (this is called a self-declaration). Of course, such a declaration is credible only if first party auditors are genuinely independent and free of bias. If you decide to use first party auditors to make a self-declaration of compliance, make sure that they aren't auditing their own work. Second party audits are external audits. They’re usually done by customers or by others on their behalf. However, they can also be done by regulators or any other external party that has a formal interest in an organization. Third party audits are external audits as well. However, they’re performed by independent organizations such as registrars (certification bodies) or regulators. The third party audits are very important sometimes because Global regulatory agencies (including the FDA, EMA, HC, TGA, etc.) require manufacturers to conduct internal audits to verify the suitability of their QMS systems. In addition, many companies have routine third-party audit programs where an independent organization verifies that a company’s systems and processes meet the appropriate standards and regulations.


First party audit – is performed within an organization to measure its strengths and weaknesses against its own procedures or methods and/or against external standards adopted by (voluntary) or imposed on (mandatory) the organization. A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited. First-party audits are often called internal audits. This is conducted when someone from the organization itself will audit a process or set of processes in the quality management system or food safety management system to ensure it meets the procedure that the company has specified. This person can be an employee of the organization or someone hired by the organization to perform the internal audits, such as a consultant, but the important thing is that the person is acting on behalf of the company rather than a customer or certification body. This type of audit is focused not only on whether the company processes meet the requirements of a standard, but all rules the company has set for itself. The audit will look for problem areas, areas where processes do not align with each other, opportunities for improvement, and the effectiveness of the quality management system. By design, these audits can and should be much more in depth than the other audits, since this is one of the best ways for a company to find areas to improve upon.


Second party audit – is an external audit performed on a supplier by a customer or by a contracted organization on behalf of a customer. A contract is in place, and the goods or services are being, or will be, delivered. Second-party audits are subject to the rules of contract law, as they are providing contractual direction from the customer to the supplier. Second-party audits tend to be more formal than first-party audits because audit results could influence the customer’s purchasing decisions. A second-party audit is conducted when a company performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract. These requirements may include special control over certain processes, requirements on traceability of raw materials (knowing which raw materials/ingredients are used in which products), requirements for special cleanliness/hygiene standards, requirements for specific documentation, or any of a host of other items of special interest to that customer. These audits can be done on-site by reviewing the processes or even off-site by reviewing documents submitted by the supplier. The customer can audit all or part of the contract – whatever they see a need to audit. It is important to understand that a second-party audit is between the customer and the supplier and has nothing to do with becoming certified. Many people thought that second-party audits would not be necessary once a company is certified to ISO 9001/ISO 22000 by a certification body, but this is not necessarily true. Even if you are certified by a third-party audit, any of your customers may still want to perform a second-party audit to look at elements of their contract, especially if these elements are not the same as the ISO 9001/ISO 22000 requirements. This is not required by all customers, and is not required to be certified to ISO 9001/ISO 22000 by a certification body, but it is specified in some contracts and there are some customers that choose to perform these audits.

Third party audit – is performed by an audit organization independent of the customer, supplier relationship and is free of any conflict of interest. Independence of the audit organization is a key component of a third-party audit. Third-party audits may result in certification, registration, recognition, an award, license approval, a citation, a fine, or a penalty issued by the third-party organization or an interested party. A third-party audit occurs when a company has decided that they want to create a quality management system (QMS) or a food safety management system (FSMS) or environmental management system (EMS) that conforms to a standard set of requirements, such as ISO 9001/ISO 22000/ISO 14001. Then hire an independent company to perform an audit to verify that the company has succeeded in this endeavor. These independent companies are called certification bodies or registrars, and they are in the business of conducting audits to compare and verify that the QMS/FSMS/EMS meets all the requirements of the chosen standard, and continues to meet the requirements on an ongoing basis. They then provide certification to companies that they approve. This can be used to give customers of the certified company confidence that the QMS/FSMS/EMS meets the requirements of the chosen standard. There are three types of audits used in this process, called certification audits, maintenance or surveillance audits, and re-certification audits.

Purposes of audits
An auditor may specialize in types of audits based on the audit purpose, such as to verify compliance, conformance, or performance. Some audits have special administrative purposes such as auditing documents, risk, or performance or following up on completed corrective actions.

Certification; Companies in certain high-risk categories such as toys, pressure vessels, elevators, gas appliances, and electrical and medical devices—wanting to do business in Europe must comply with Conformité Europeënne Mark (CE Mark) requirements. One way for organizations to comply is to have their management system certified by a third-party audit organization to management system requirement criteria (such as ISO 9001). On the other hand, some products can be exported to certain markets if they are certified with given certifications such as HACCP or HACCP based food safety management systems. 


Customers may suggest or require that their suppliers conform to ISO 22000, ISO 9001, ISO 14001, or safety criteria such as OHSA, as well as federal regulations and requirements may also apply. A third-party audit normally results in the issuance of a certificate stating that the auditee organization management system complies with the requirements of a pertinent standard or regulation.

Third-party audits for system certification should be performed by organizations that have been evaluated and accredited by an established accreditation board in the given country or territory. 

Monday, December 28, 2015

Constraints and Compliances of Traceability in Low Grown Orthodox Black Tea Manufacturing Process

C. V. K. Lokunarangodage1*, I. Wickramasinghe1, and K. K. D. S. Ranaweera1.

1Department of Food Science and Technology,
University of Sri Jayewardenepura, Nugegoda, Sri Lanka.

*Corresponding author:vindikal@gmail.com,
Received June 05, 2015; Revised June 22, 2015; Accepted July 05, 2015

Abstract
Traceability practices and their compliances in low grown orthodox black tea manufacturing process were examined, while proposing possible solutions for identified major drawbacks. The physical traceability in supply chain was considered one step forward and one step backward from the point of manufacturing, starting from auction/buyer back to supplier. Randomized stratified sampling was used. The traceability was evaluated using a checklist, end product sampling, open ended interviews, observations and internal document studies. The orthodox process was more complicated unlike other production processes due to the different separation techniques employed for grading and variety of grades produced because the sifting/grading was the key to number of different tea varieties. Major traceability issues were observed in leaf collection and grading operations due to complexity of separation through Myddleton, Chota, Michie and Winnower, which reduced the specific amounts produced, where bulking and blending process further extended complexity, while increasing the mixing of different made tea together with increased number of suppliers. Considering 1st, 2nd, 3rd dhool and big bulk with given separation techniques during grading; a single tea leaf could pass many paths before it end up in a specific product due to weight, size and shape of the leaf of a shoot based on the way it was rolled in orthodox rollers, where traceability up to tea bush, grading, blending and traceability of sample back to supplier was not fully complying. Nevertheless, supplier records, traceability after packing, traceability at dispatch and after dispatch were in full compliance, and other factors had varying degree of traceability compliances which make the compliances unachievable. Alternatively, if made tea is considered as bulk material, use of emerging technologies like Radio Frequency Identification (RFID) tags or/and DNA barcoding may be potential tools in rectifying such drawbacks and further research is needed to assess their efficacy in the field.


Key Words: Orthodox Black Tea, Manufacturing, Traceability, Compliance, Myddleton Shifter, Supplier, Grading, Dhool. 



1. Introduction
Tea was known as a beverage at least for over 5000 years, it was initially considered as a medicine and later grew into a beverage which finally became the most popular beverage in the world or the second most important drink after water [1]. According to the Chinese legends, tea was first discovered in the time of Second Emperor and herbalist, Shennong in 2737 B.C.E, accidently when a dried tea leaf was fallen into the boiling water which was intended for quenching emperor’s thirst; who drank boil water as a habit, while he was travelling to another region.

The commercial planting of tea in Sri Lanka was introduced by a Scotsman, James Taylor in 1867 [2]. Since then the Ceylon Tea has been the world’s number one brand for over a century and the local tea industry has made a significant growth over the time while securing its position in the global market as a leading producer and exporter of high quality black tea. In terms of international trade, tea is one of the major export revenue earners for the country, where thousands of lives are depending on it directly or indirectly.  In 2007, Sri Lanka was the fourth-largest tea-producing country according to global production statistics and the country has produced 318,470 tons of tea which contributed nearly 9.1% of the world’s total tea production [3].

Nevertheless, country has dedicated over 221,000 hectares or approximately 4% of the total land area for tea cultivation [4]. Accordingly, Sri Lankan tea plantations can be categorized as large plantations as well as smallholdings and there are approximately 118,274 hectares of smallholdings with 397,223 smallholdings [5] out of the total land cultivated; around 43% is managed by the corporate sector, with a production of about 35%, while the balance of 57% is in the smallholder sector, with a production of 65% of the total. The average productivity in the smallholder sector is substantially higher, at about 1,853 kg/ha compared to the corporate sector productivity of 1,459 kg/ha [6]. The production grows at an annual rate of around 10% [7] while current average production amounted around 328 million kilograms in 2012 with majority of black tea. The annual production contributed from 14 tea growing districts of the country with figures of low grown 62%, mid-grown 16% and high grown 22% respectively, while 99% of the produce was black tea out of which 92% of the produce were accounted as orthodox black tea and 7% was accounted as CTC (cut, tear and curl) [5].

Considering current trends in export market, tea is moving worldwide as a healthy beverage which has advantages of availability but disadvantage of complex supply chains. Today global food competition is more intense where stakeholders started to adapt their mind sets toward a more holistic approach on supply chain management while focusing on food safety and traceability in a farm-to-fork perspective [8] because food industry has drastically changed during recent decades [9]. Nevertheless, many governments are improving food safety measures to safeguard their citizens by increasing control at all stages of food production, processing and distribution with hazard analysis critical control point (HACCP) and traceability based food safety management systems (FSMS) such as ISO 22000: 2005. According to Food and Agriculture Organization of the United Nations, traceability requirements are gaining significance in the global tea economy, with the potential for significant impacts on the world’s tea producers, which is expected that the demand for traceability will result in widespread industry restructuring, which will require institutional responses within each of the major tea-producing regions [10]. The traceability is used as a tool to track product movement through manufacturing and distribution chain up to end user and backward to raw material supplier. Today consumer safety is the firm concern, which is a matter of cooperation between all actors involved in food supply chain rather than a confrontation; with the sharing of information, use of common standards and languages to pinpoint the food safety issues [11].

Concern over food safety is becoming central to supply chain restructuring in tea. Due to the costs, sampling and methodological constraints associated with the monitoring of finished food products, there is a trend towards preventing contamination at source through monitoring of estate and factory processes. This is associated with traceability based food safety management systems such as Good Agricultural Practices (GAP), Good Manufacturing Practices (GMP), ISO 22000 and HACCP certification. The second driver of traceability is consumer demands for independent verification that teas have been produced in the absence of abusive labour practices, by respecting worker rights and providing a living wage to smallholders, and by not polluting the environment or threatening biodiversity [10].

According to the ISO 9001:2000 standard, traceability is defined as “The ability to trace the history, application or location of product or service that is under consideration”[12],  which is a process that makes it possible to find the traces of the various steps (manufacturing steps, sources of its raw materials with relevant suppliers, controls and tests carried out) and locations (storage locations,  equipments used to manufacture or handle it, direct customers and end users) a product has passed through from its creation through to its final disposal [11]. Traceability requirements in food supply chain due to consumer concerns were started to rise in the later part of nineteenth century with the discoveries of microbes as well as vitamins which were further increased due to the development of supply chains followed by the improved production methods [13]. The product traceability is the ability to follow the food movement through specified stages of production, processing and distribution in one step forward and backward at any given place of the food supply chain, while facilitating efficient product recall in the event of hazard left the production facility.  As a result of global, integrated partner oriented approach throughout food supply chain, every operator must identify their product in a unique way while recording their destinations with the links between incoming and outgoing products as well as end users on databases [11]. 

Further, product traceability helps to determine the origin of a food safety problem and to comply with legal requirements while meeting consumers’ expectations for the safety and quality of purchased products [14]. The aim of all these measures is to safeguard consumers from biological, chemical and physical hazards that may be present in food while implementing full traceability in food supply chains. According to the Kelepouris et al. [15], Morrison [16], Van Dorp [17] Viaene & Verbeke [18] full traceability or traceability throughout entire supply chain is essential for ensuring food safety and quality which was mainstream requirement to regain or maintain consumer confidence, where traceability cannot improve food safety or quality itself although it can provide necessary information and keep track of product movements [19]. 

Considering the complex nature of tea supply chain as well as the complex manufacturing operations involved in the tea industry, it is very difficult to identify the movement of a given supplier’s raw material throughout the production process at a single glance. It was rarely discussed subject in many researches, where black tea’s health benefits, chemical structures, disease prevention etc., has been extensively studied by many researchers. The existing manufacturing processes are also very old when compared to most of the modern food industries where traceability was not a major concern over a century.  Hence the propose of this study was to find out the major drawbacks in the area of traceability  by analyzing factors affecting the traceability process in orthodox black tea manufacturing and to find out possible solutions to the issues identified in the study.



2.  Materials & Methods
The project designed to evaluate the problem areas of the tea manufacturing process related to the food safety applications and then to find out reliable solutions with minimizing or eliminating the existing complications through Pareto principle. The sampling plan was randomized stratified sampling, with the use of Factory Information.xls provided by the Sri Lanka Tea Board which was used to select tea factories based on the availability or non-availability of food safety or quality assurance certifications from the low grown orthodox black tea manufacturing industries.  The most prominent area was the Southern province while Galle, Matara and Rathnapura districts were set as major target areas for the project execution due to the fact that most of the orthodox black tea factories were located in these areas and the easy access as well as shorter distances between factories, where concentration of factories were high. The project has two phases for execution and sample size for each phase was 30 factories where phase II was focused mostly on the factories which have ISO 22000/ISO 9001/HACCP systems or Good Manufacturing Practices with Japanese 5S implementations. However, there are number of tea factories which have abandoned the implemented food safety management systems due to various reasons, where additional priority was given to understand the problems they faced, that led to abandoning as well as to find out the remaining practices and their efficacy.

The first stage was completed with gap analysis to evaluate the basic major issues which has more impact on food safety and the product quality with the evaluation of 25 tea factories that have not implemented ISO 22000/HACCP food safety management system (FSMS). The second stage was designed based on the output of the first stage audits, where another set of 20 factories were analyzed and which have ISO 22000 FSMS/HACCP or previously implemented but currently abandoned. The audits had two dimensions where first major audit was targeted to identify the issues prevailing in the food safety management systems and their supporting documents while second objective was to find out traceability of the manufacturing process as a part of generic model development. The internal audits were designed based on ISO 22000 food safety management system requirements and root cause analysis carried out at the gap analysis stage which pointed out the issues in industry as well as strategic approaches to the problems identified while traceability was a major concern from the gap analysis. 

In addition to the gap analysis and internal audits conducted in stage I and stage II, separate traceability study was carried out in parallel to the stage I and II to understand the traceability applications and practices in tea industry using over 40 tea factories with or without ISO 22000 or HACCP FSMS or ISO 9001 QMS. The selected factories were evaluated based on the visits made in parallel to gap analysis carried out at phase I and internal audits conducted in phase II. Required data was collected through standard check list followed by open ended discussions. A traceability exercise was conducted for a selected made tea sample, practically trying to trace back green leaf supplier for selected sample with the help of available documents/records and employees working on relevant processing areas.  

The two testing criteria were common for all the factories evaluated and special attention was given to the factories which were currently practicing ISO 22000/ISO 9001/HACCP systems or previously followed even though the certifications were expired. The checklist was prepared considering the various standard requirements of traceability.

The results of the study were analyzed using MINITAB 17 Version and 1-Proportion test was applied for the results at 0.05 significant levels. Hypotheses were built based on the proportion of factories which were complied with traceability factors and results were separately analyzed for every factor.



3.  Results and Discussion
According to the evaluations carried out, over 45 factories were observed and complete data was observed on 40 factories with or without ISO 22000, HACCP or ISO 9001 certifications. The traceability was evaluated using a checklist, end product sampling, open ended interviews, observations, and internal document studies in all the tea factories. As to the results, traceability was found in place up to a certain extent in all the tea manufacturing processes from one step forward. It was mostly limited to the made tea up to auctioneer or the wholesale buyer after completion of the manufacturing process, where made tea could be traced from manufacturer through product coding, manufacturing date, brand, and name of the manufacturer up to auction and through auction records purchaser can be located.

According to the CBI, the consumer markets were dominated by the popular blended brands which can contain up to 36 different types of tea varieties that were blended in the consuming country to ensure the unique taste of their brand at a competitive price where tea buyers source different teas from around the world mainly China, India, Kenya and Sri Lanka [1]. Accordingly, buyers blend tea after purchasing according to their brand’s requirements depending on the market and cost. Therefore, the process was complex and the traceability will lead to a bunch of manufacturers rather than a single manufacturer.

Thus rest of the traceability was not studied because most of the purchases were export oriented and it was beyond the research objectives. However, that can be traced up to the consumer since no processing was involved other than blending, repacking or value addition according to the consumer preferences.  Thus traceability of a product complains can be elaborate as consumer claim to retailer, who claim to wholesaler and who will then inform the buyer through auctioneer and the manufacturer. If there is a product recall, the same channel can be used vice versa.


Figure 1. Constraints and Compliances of Traceability in Low Grown Orthodox Black Tea Supply Chain   

The results of the study was given in the bar chart above (figure 1), which illustrate the traceability practices as well as the achievements in the factory flow level. Further to the results obtained traceability up to tea bush, traceability in grading, traceability in blending and traceability of sample back to the supplier wasn’t fully complying according the study sample (p < 0.05). On the other hand, supplier records, traceability after packing, traceability at dispatch and traceability after dispatch was fully traceable or all the tea factories were in compliance with these four factors (p = 1) . As a rule of thumb, other factors had varying degree of traceability compliances, which indicated that those areas were more or less neglected but it was not impossible. The figure 02 below shows the probability of implementation and it further prove that what were already implemented and what was not achieved due to explained reasons or neglected according to the representative sample. 


Figure 2. Implementation Probability of Traceability in Low Grown Orthodox Black Tea Supply Chain


When considering traceability in one step backward, none of the bought leaf based tea factories were able to exactly locate the farmer or the field where green leaves were harvested. Large estates were able to locate the field of the harvesting carried out, but they also unable to locate the records of exact tea bush or the labourer who harvested a given green leaves which mostly process in their own production facility. On the other hand, smallholder suppliers were more critical because their leaves were mixed each other while collecting and transport, where traceability was only possible up to a bunch of suppliers. 

Bearing in mind the traceability up to tea bush which was the primary objective, a quantity of 4.50 – 4.65 kg of green leaves were required to manufacture 1kg of made tea (final product) [20]. 1kg of green leaves were to be harvested from 20 - 30 tea bushes with average yield where it is extremely difficult or almost impossible to practically locate the exact tea bush in the case of a product complain or hazard occurrence. The most possible paper based system could reach the leaf collectors or bunch of suppliers approximately, but it was impossible to locate the exact supplier or tea bush who contributes to the issue. Thus one-step backward traceability in orthodox black tea manufacturing was rarely achieved due to following reasons in smallholder suppliers. Most of the suppliers were smallholders who had less than one hectare of lands, which produce less than a single roll charge in a one supply of green leaves. It was usually varying around 3 – 15 suppliers at a time. Tea cultivation requires a relatively small investment, and the risk of complete crop failure is low. Problematic issues for smallholders producing bulk tea products include low farm gate prices, poor extension services and limited marketing channels [1]. As a result, their tea leaves were mostly collected through leaf collectors. According to keleporis et al, successful implementation of supply chain traceability calls for cooperation among all the stakeholders of the supply chain [15]. According to the interviews conducted, leaf collectors were not educated enough by manufacturers to keep traceability records. On the other hand, cost of additional labour and transport was high, where leaf collectors were operating at little margins. Nevertheless, leaf collectors as well as factory employees also believe that tea leaves are a uniform and homogenous raw material; origin in similar fields which cannot be distinguished each other very easily. Thus it was very difficult to motivate them to practice traceability in supply chain, where extreme competition for leaves in the market has the bargaining power for them to change the manufacturer at any time without notice.  

After withering during release to the rolling process, small quantities were bulked or large quantities segregate to make a single batch of size about 250kg depending on the dryer capacity, which was call the charge, [21] and this activity increased the mixing of direct smallholder suppliers as well as leaf collectors. According to the study sample (as shown in the figure 1 – traceability compliance), 18 factories maintain collector bulks with identification tags (p > 0.05), thus the leaf could be traced with time records backward to leaf collectors as well as bunch of smallholder suppliers at a given date but it was impossible to trace up to the exact supplier or the tea bush. The same leaves could be traced forward through rolling, fermentation, drying up to fiber removal, easily with time records when the production was arranged in such a way. 

Typically, orthodox black tea manufacturing process was much more complicated unlike other production processes (e.g. CTC) due to the different separation techniques employed as well as the number of different varieties produced. Hence, most critical part of the tea traceability systems was to trace the product within the manufacturing process. The sifting/grading was the key to number of different tea varieties and ungraded dry tea leaves initially pass through Myddleton after fiber removal. According to Samaraweera, the Myddleton bubble tray stalk extractor has an oscillation motion of 200 to 220 oscillations per minute of two aluminum bubble trays with perforations where bubbles impart a string action at the bottom of the layer which makes long particles such as fibers or stalk to float. It helps small and round particles to settle at the bottom of the layer while top particles to fall through perforations. To achieve this action, it must be feed with a continuous thick layer without exposing the bubbles, which will sort the stalky long leaf portion by passing through a tray that is used to separate long leaf particles and stalks at the beginning of the sorting process [21]. 

Thereafter, Chota and Michie shifters were used to separate uniform sizes and then to different varieties. Michie oscillatory shifters were equipped with one or two trays stacked one on top the other with a slight slopes towards forward direction that gives oscillatory motion on the vertical plane which help particles to jump forward at 250 to 260 oscillations per minute. Michichi shifter was used to separate long and wiry particles which were basically used to produce long leaf and wiry grades [21]. After separations, semi graded tea was then passed through a winnower to separate according to the weight. The winnower is used to separate light tea particles such as flakes, fibers, tea fluff and extraneous matters such as sand or dirt [21].  

However, this process was very complicated and very difficult to understand easily for an average person. Considering 1st dhool, 2nd & 3rd dhool as well as the big bulk, given generic process flowcharts (figure 3, 4 and 5 below) were drawn where it was obvious that single tea leaf could pass many paths before it end up in a specific product due to the weight, size and the shape of the leaf of a shoot based on the way it was rolled in the orthodox rollers. 

On the other hand, consider the same leaf if it broken to small sizes and large sizes they normally end up in two different grades. The same shoot’s tender leaves will mostly end up in first grades while matured low weight leaves will mostly end up in second grades based on the weights.  Considering the complexities involved, the figures 3, 4, and 5 shows the number of different grades produced in a given dhool. It was almost 32 for a first dhool (figure 3) considering the generic processes without 2nd or 3rd grade products where their sizes were different from one another as well as different parts of the tea shoot. 

This phenomenon was almost same for all the dhools where it wasn’t a very easy process to keep records of the product movement. Nevertheless, the second grades were much less discussed in the orthodox black tea manufacturing process but those amounts were also massive and their movements were never recorded in the industry on accurate manner, where the existing traceability practices were not complete. The existing systems had introduced various documents to keep traceability tracks on the product movements, but none of them were able to comply with the theoretical traceability requirements according to the definition of traceability [12]. 

According to the given process flow diagrams below, one tea leaf might pass many times through Myddleton, Michie and Winnower as well as the Colour Sorter before it reached the final grade. Some leaves may recycle the same path again and again with mixing new coming ungraded teas such as throughput of 5mm Myddleton which go back again to Chota (red line – figure 3, 4 and 5) and passing through same sieves before end up in a final grade. On the other hand, each time the product went through winnower, based on the weight; it separates the product into 1st grade, 2nd grade, 3rd grade and fiber while removing stones and other extraneous particles and reducing the bulk into small quantities. 1st grade was proceed with next steps of manufacturing process, while 2nd and 3rd grades were followed separate pathways which generates second quality tea products which were usually called second selling mark products. Considering 1st dhool, 2nd dhool, 3rd dhool and big bulk, when each of these process flowcharts were equally complicated and largely distributed, it was very difficult to follow a paper based or even a digital method to track down the traceability of a specific tea leaf.   


Due to the continuous feeding and requirement of uniform thickness in Middleton shifter; batches couldn’t be separated accurately rather than guessing. Thus there must be number of documents and complex storing systems to identify different batches as well as batchwise separation techniques which will add more cost to the production. While dried tea was passing through shifters within grading room operations, the same bulk was separated into small different grades based on leaf size, type, dhool, weight and buyer requirements where orthodox black tea has around 30 different grades basically which further creates issues in reaching the initial leaf supplier.


Figure 3 – Graphical representation of generic process flow chart for the 1st Dhool sifting program of orthodox black tea


Figure 4 – Graphical representation of generic process flow chart for the 2nd & 3rd Dhool sifting program of orthodox black tea


Figure 5 – Graphical representation of generic process flow chart for the Big Bulk sifting program of orthodox black tea


There are various other processes involved, but these processes were the major critical points for the traceability issues in orthodox black tea manufacturing unlike the cut, tear and curl (CTC) process where it is easily traceable due to non-complex process which give less varieties as well as large quantities. In orthodox process, the output of a single grade was small where several batches were required to prepare a standard quantity for packing or as to buyer requirements, thus bulking is needed.


Figure 6. A Typical Blending Operation

The blending (Figure 6) was carried out to give specific product characteristics to a given tea product where different grades are mixed together. Hence this process further increase the traceability issues while increasing the number of raw material suppliers as well as individual tea plants contributing to a given tea product. Nevertheless, these areas still can be traceable with a proper organization of production flow and better recording systems which was not available in any of the systems evaluated. The cost is one of the major factors which decide the implementation of such measures, because even though the factories are fully dedicated and implemented such systems, the buyers do not pay attention to such efforts while they were involved in purchasing. Thus it is inappropriate to request complete treatability from manufacturers without providing solutions to the areas mentioned in the study.

On the other hand, if orthodox black tea manufacturing was considered as a bulk material, the traceability can be achieved with less hazardous work load where bunch of suppliers or fields were the primary objective.  Then paper based traceability systems can be developed to trace single day’s production which can be more easily segregated while storing and recording where it can be traced through grading and blending up to packing. Nevertheless, it can be trace one step backward practically up to bunch of suppliers through existing records while adding few new records within grading operation from drier out to finished product packing. Rest of the areas of manufacturing namely receiving, withering, rolling, fermenting and drying can be managed through addition of time records or codes to the existing food safety management systems.    

Finally, if the cost is bearable to the consumer, DNA barcoding is a widely used molecular-based system, which can identify biological specimens, and is used for the identification of both raw materials and processed food, which can be possible to employ to identify exact issue concerning samples [22].  On the other hand, Radio Frequency Identification (RFID) tags also can be integrated to track down the raw material movements as well as finish product by using the passive RFID tags with the bulk storing bins from field to the factory and then after drier moth to the packing since raw material and finish product both moved within plastic crate which can be continually used with a reader. The passive RFID tags are designed to depend on the tag reader as its power source where reader unit can communicate with the tag within 6 meters which are low in product cost and it is manufactured for disposal with disposable consumer products [23]. Considering current developments in RIFD tags technology, it possibly can be used in the complicated operations in orthodox black tea manufacturing process to track down intermediate product movement within the factory environment where the production should plan according to the requirements while synergizing with existing paper based systems to make it workable. However given model will be able to identify the traceability on the bulk movement where individual supplier and the end user can be located. But these technologies are not currently applied in tea trade where it will not guarantee the accurate identification of exact tea bush in an event of hazard occurrence which needs further research to explore the possibilities of exact application of the given technologies.

Accordingly, the research recommends considering tea as a bulk material like edible oils in the event of processing where it is really practical to consider traceability after made tea left the factory and if there is any food safety issue manufacturer has to address all the suppliers in the supply chain and check their plantations for identification of abnormalities, if necessary. If the made tea is considered as a bulk material, it will be helpful to develop user friendly, realistic and practical paper based traceability models which will not increase the product cost or unnecessary documentation works for the quality assurance system operators. 


 
4.  Conclusion
As to the results, traceability was found in place up to a certain extent in all the tea manufacturing processes from one step forward. The research was limited to the made tea up to auctioneer or the wholesale buyer after completion of the manufacturing process, where made tea can be traced from manufacturer through product coding, manufacturing date, brand, and name of the manufacturer up to auction and through auction records, purchaser can be located.

When considering traceability in one step backward, none of the brought leaf tea factories were able to exactly locate the farmer or the field where green leaves were harvested. Large estates were able to locate the field of the harvesting carried out, but they also unable to locate the records of exact plant or the labourer harvested a given green leaves which mostly process in their own production facility. On the other hand, smallholder suppliers were more critical because their leaves are mix each other while collecting and transport where only possible up to a bunch of suppliers. Bearing in mind the traceability up to tea bush which was the primary objective, a quantity of 4.50 – 4.65kg of tea leaves were required to manufacture 1kg of made tea. 1kg of green leaves were to be harvested from 20 - 30 tea bushes with average yield where it was extremely difficult or almost impossible to locate the exact tea bush in the case of a product complain or hazard occurrence. The most possible paper based system could reach the leaf collectors or bunch of suppliers approximately, but it was impossible to locate the exact supplier who contributes to the issue or tea bush.

Typically, orthodox black tea manufacturing process was much more complicated unlike other production processes due to the different separation techniques employed as well as the number of different grades produced. Thus most critical part of the tea traceability systems was to trace the product within the manufacturing process. The sifting/grading was the key to number of different tea varieties.  Considering 1st dhool, 2nd dhool, 3rd dhool and big bulk, when each of these process flowcharts are equally complex and largely distributed, it is very difficult to follow a paper based or even a digital method to track down the traceability of a specific tea leaf.  According to the given results and the observations it was obvious that orthodox black tea production process was very complicated, where it was suitable to consider as a bulk material in the event of traceability which help to develop user friendly traceability systems in orthodox black tea manufacturing process. On the other hand, use of emerging technologies like Radio Frequency Identification (RFID) tags or/and DNA barcoding may be potential tools in rectifying such drawbacks and further research is needed to assess their efficacy in the field.

Considering all these factors, it was obvious that tea traceability practices were very complicated to the manufacturer and product was not priced considering these critical factors. Thus requesting traceability from the consumer’s tea cup back to the tea bush that supplied green leaves to produce the given made tea sample was not justifiable as well as very difficult in the manufacturing process. However, educating all the stakeholders may help to improve the traceability practices up to certain extent, but if the manufacturer can increase the hygienic practices to improve the food safety of the product, while educating all the stakeholders in supply chain that will be more meaningful than considering the traceability as a critical buying factor due to the complex processing nature of the product. 




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