Overview
o2b Healthy
Company Profile
o2b Healthy is the trading name of Contract Manufacturing of Supplements Ltd ("CMS") located at 7 Elms Street, Wakatu Industrial Estate, Stoke, in Nelson. We are licensed to manufacture Meat, Seafood and Dairy products as well as dietary supplements. Our manufacturing processes include size reduction (milling), blending, encapsulating, tableting and bottling.
The company produces nutraceutical products from a range of plants, animal material and animal products and has been operating since 2003. Our products are produced mainly for the local domestic markets with some exports through third parties. Because of the types of products being produced, CMS operates under the Animal Products Act 1999 which requires regular visits from New Zealand Food and Safety Authority (“NZFSA”) VA for verification to enable exporting of products to countries that require official assurances.
Quality Policy:
We are committed to ensuring our customers receive quality products and services that will ensure enduring relationships of mutual benefit to our customers and CMS alike.
The purpose of the Quality Manual is to implement and continuously maintain our commitment to these objectives through a dynamic Quality Management System based on applying Good Manufacturing Practices, and Risk Management Principles based on the HACCP technique.
Quality control is an integral part of all the corporation’s management and production processes. It is not a separate element or function; each and every aspect of the day-to-day operations of the corporation is conducted in accordance with the quality policies contained within the Quality System. It is designed to integrate human, technical and material resources in a manner that results in optimum production consistent with the highest possible quality standards.
There are no exceptions to this commitment. Each and every employee is expected to understand and maintain our core quality principles, procedures and commitment.
Our success is measured by satisfied customers. This Quality Management System reflects the corporation’s total commitment to achieving the goal of meeting the needs of our customers efficiently and safely.
The Management Team is responsible for the implementation and ongoing supervision of the quality procedures. This administrative responsibility complements but in no way reduces or removes the line responsibility of managers, supervisors or employees of their quality control duties. Quality is everyone’s business and our fundamental goal.
The Quality Assurance system is based on ‘Risk Management Principles based on the HACCP technique’:
Facilities:
The site is approximately 2000m2. The shell of the plant is the existing building which is 1000 m2; this was formally the site of Collier Watson.
The processing premise has been built out of food grade materials. The materials used for construction are Cool Store Titania/Titania colour steel insulated panel wall panels and ceiling panels. They are installed with protective strips at the construction joints using anodised aluminum extrusions sealed with the New Zealand Ministry of Agriculture & Fisheries (“MAF”) approved sealant.
The shell is approximately 1000 m2. The Reception Store is approximately 126m2, the dispatch store is approximately 220m2. The processing plant is approximately 390 m2.
No other person or business uses the premise for manufacturing of any product.
External Audits:
As a result of the existing legislation to which CMS Ltd is licensed against, the external audit frequency is determined on a “Performance Based Verification” system. At present New Zealand Food Safety Authority Verification Agency carries out audits for our Licensing.
Standard Operating Procedures:
Standard Operating Procedures (“SOPs”) are the responsibility of the Quality Assurance Manager. This includes implementation, monitoring and document control. The Quality Manager has the overall responsibility of ‘Product Quality’.
SOP’s detail operating procedures on how the company implements the systems based off step by step instructions on how to perform each particular task, this is so that reproducibility can be achieved with no difference in the end results. They detail the requirements so as to be able meet and ensure regulatory requirements and include records which detail the process to provide evidence of compliance to specifications.
The Sections of the SOP include the following information:
· Revision History - List all dates and reasons why the SOP has been reviewed throughout its history
· Introduction - Includes the Scope/Purpose, and a Statement of Intent of the SOP and Definitions if required
· Materials/Equipment - Lists all Materials and Equipment that will be required to perform the actions that are detailed in the SOP
· Special Precautions/Safety Aspects - Lists any Safety Procedures that must be followed while performing the actions that are detailed in the SOP. Any potential hazards must be identified
· Procedure – Process for the job in the sequence in which the work is done
· Responsibility - A detailed structure of responsibilities with designations
· Related SOPs and Exhibits - List any SOPs that are related to the SOP being reviewed. Include examples of any Exhibits, labels, and work sheets etc. that are relevant to the SOP
· All SOPs must be reviewed before their expiry date is reached. After being reviewed, the SOP is reissued (as a revision) with a new expiry date
· The maximum lifetime of a SOP is two years
Formulations:
The Technical Manager has the overall responsibility of creating new product ranges. It is to ensure that the product formulations meet regulatory requirements and that recommended daily intake limits are adhered to. The Technical Manager also has the responsibility of sourcing raw materials to meet the required standards which are currently dictated by FSANZ (Food Standards Australia New Zealand) these formulations are verified by the Quality Manager before production occurs. Suppliers of raw materials are approved on the basis of service, quality product and costs. The decision to who can approve these suppliers is carried out by the Technical Manager based on the supplier’s ability to be able to provide materials to an applicable standard. These standards are designed to ensure that materials and substances added to food are of a suitable and safe standard to consume and are of a standard suitable to be able to meet label claims.
Labeling and Traceability:
On arrival, all products and items used in manufacture are allocated an UNIQUE NUMBER which is recorded in the Inwards Goods Register where details of the product and material are recorded. When a job is created, this job is issued a BATCH NUMBER. This number stays with the product until the product is either consumed by the consumer unless the product is produced by CMS and received back into stock for packing, a new batch number will then be issued with the packing documentation.
Each Batch Manufacturing Record contains information as to where the product was sourced from (which Inwards Goods Register Number and Raw Material Code). This allows for traceability from start to finish and from finish to start.
Labeling is carried out according to NZ regulations for the production of food products and materials, both locally and overseas. Customer labels are applied and the relevant BATCH NUMBER and EXPIRY DATE are applied. In the case of Contract manufacturing jobs for customers, label content remains the ultimate responsibility of the customer.
Quality Control:
The responsibility of the Quality Control function is to ensure that the manufacturing, storage and distribution of products are fit for intended purpose. This means that customer satisfaction and regulatory requirements are maintained. Approved testing including microbiological and analytical is carried out by an approved laboratory.
The activities of the Quality Control Department are as follows:
· Inspection and testing of raw materials, in-process materials and finished products against approved specifications; and
· Sampling of products and materials including retention samples, samples to be sent to approved laboratories; and
· Verification of actions carried out by staff are in accordance with documented procedures and policies as defined by the Quality Manual; and
· Environmental monitoring including cleaning verification, pest management and pathogen management; and
· Review of records including and evaluation of production documentation and an assessment of deviations from specified procedures;
· Maintain records which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated
Self Inspection:
The quality system is designed for increased operator ownership and as such, internal audits form a basis for monitoring the overall performance of the quality system – both documented and in reality. These audits are carried out by the Quality Manager.
Each internal audit outcome is documented on a review form which identifies the issue, the solutions and the timeframe to correct the issue. As a result, the Quality System is forever changing and improving to meet new regulatory or customer requirements.
Self Inspection is based on the following principle of inspection (various SOP’s describe each topic under each level in detail):
Level 1 inspection:
· Carried out by Quality Control Staff
· Daily and weekly checks
Internal Compliance Monitoring
· Quality Control verification of processes, personnel, premise and produce meeting defined standards, procedures and policies on a day to day basis
· This also includes weekly checks and a weekly review of records and actions taken to correct any non-conformances
Quality Control Sampling and Testing
· As per sampling and testing program
Level 2 Inspection:
· Carried out by Quality Manager
· 6-monthly
Internal Audits
· Carried out by either the Quality Manager and/or external audit contracted by CMS LTD
· Assessment of effectiveness of the system
Customer audits
· Customers may audit us as and when they decide
Training:
Training of staff begins with an induction that covers the basic requirements for working at CMS Ltd. This includes a site tour, introduction to key staff, a brief overview of company policies, and health and safety regulations. New employees are assigned a buddy to work with until such time as they are deemed to be competent by senior staff. During the first months of work, they are under a probation period of which meetings are held with them to provide feedback on performance and an opportunity for them to give feedback on how they are fitting in with the team.
Each department head is responsible for training and assessing what training needs are required for each individual, this covers the training for On Job Training and SOP Training. Employees are given training either as a group or individual.
Employees are trained in how to use the Quality System. That is SOP’s, Task Descriptions as well as Hygiene and Sanitation as per each functional areas SOP requirements.
Training is carried out using in-house personnel. In-house training is carried out by Management while supervision on the job is carried out by senior staff.
Employees are retrained when one or more of the following situations have occurred:
· Corrective actions are taken as a result of employee error
· Monitoring of staff performance identifies employee continually not following written procedures
· Review by department head
Health Requirements for Personnel Engaged in Production:
Each department head is responsible for checking health of employees. This includes but not limited to sickness, injuries and allergies.
Upon applying for a job and during the job interview, prospective employees are queried about their medical status. This includes but not limited to communicable disease, allergies, and other health issues that is important for the employer to be aware of such as on medication or physical injuries that may impact on their performance.
Health monitoring is carried out as per the health and safety plan. This is focused on the effects of the work on the employee and includes checks on OOS and hearing. Employees who are found to have an allergic reaction to any product or material being handled is removed from the area until such time that they can return to that area.
Employees are required to report any illness or injury to the department head either on occurrence or if they do not turn up to work, they are required to ring the company and leave a message so we know what is happening.
Only when employees have been off for more than three consecutive days or when the company has some concerns about the illness that has occurred, the employee is required to obtain a medical certificate and present this to the department head prior to returning to work.
The above health requirements (illness, communicable disease, injuries, etc.) apply to all persons entering the site. Contract workers and visitors are informed of the requirements on arrival or as part of the induction and as such required to notify the company of any illness that may impact of the integrity of the product.
Sanitation:
Written procedures that detail the cleaning instructions, the cleaning agents and their concentration for the method of cleaning and the frequency, have been written. Extensive staff training has been carried out to ensure adequate knowledge of these procedures by personnel responsible for cleaning. Cleaning agents may be changed from time to time but only after consultation with the chemical supplier. Cleaning agents must be approved for use under NZFSA regulations.
The evaluation of the cleaning procedures has been validated by:
· end product testing for microbiological tests
· environmental swabbing
· visual checks by cleaning staff (look, smell, feel)
· internal audits by quality control
· titration checks on chemical solutions
Water Supply:
As all products are dry blended, water is not used in the manufacturing of Dietary Supplements. Water is sourced from TDC municipal supply and has a rating of Aa. It is treated at CMS, by Ultra Violet light with a flow rate of 90 litres per minute and a bulb life of 9000 hours.
The UV treatment system is monitored daily in pre-operational checks. Routine maintenance is carried out on the water reticulation system at least 6 monthly or as required in the event of a non-conforming water test.
The reticulation pipes are labelled so as to identify which pipes hold what. They are monitored daily for leaks and annually or at the time of repairs for dead end areas, unintentional mixing of sanitation water and potable water, and that pipes are identified correctly.
Water is not directly used in the processing of products. Water is used for cleaning and sanitation only with the addition of NZFSA approved chemicals.
Water complies with the following specification:
Total and Fecal coli forms nil per 100ml sample
APC22 max.104 per 100ml sample
APC37 max.103 per 100ml sample
Personnel Hygiene Requirements Including Clothing:
Hand-washing facilities are located on entrance to each production area. These facilities consist of warm water, liquid hand soap, liquid hand sanitizer and disposable paper towels.
Protective clothing used consists of white overalls, white lab coats, white gumboots, disposable hairnets, gloves and face masks, disposable aprons and sometimes suits are worn for products that have staining properties. All protective clothing is laundered off site at a commercial laundry.
Maintenance:
The Maintenance Manager is responsible for in-house maintenance and organising outside contractors for servicing (either preventative or emergency servicing).
Any form of maintenance is scheduled, where possible, to ensure minimal risk of contamination of the product. This includes checking equipment prior to use after maintenance.
A maintenance schedule controls the preventative maintenance needed to be carried out internally and by outside contractors. This schedule includes the type and frequency of service/check.
Checks for repairs are carried out as part of the Operator Verification requirements:
· Pre-operational checks
· Internal Compliance checks
· Observations by processing staff
· As required by the maintenance plan
Once an item is found, it is transferred to the Repairs and Maintenance Log found in the Maintenance Managers office. The severity of the repairs will determine when the repairs will be rectified. The severity is as follows:
|
Risk
|
Definition
|
Timeframe
|
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Low
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product is not at risk of contamination
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As soon as possible
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Medium
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product may be at risk of contamination
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In the next break of processing or sooner if risk is increased
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High
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product is at risk of contamination
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Immediately
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Once items have been repaired, they are to be signed off by the person whom completed the repairs or the Manager.
Once a week the maintenance records are checked for completion of maintenance activities that are carried out on a regular basis.
Repairs are carried out by CMS maintenance personnel or external contractors. External contractors are to be made aware of all hygiene requirements and should be accompanied by CMS personnel when on site.
Tools are required for use in process areas, for equipment maintenance, dismantling / assembling of machinery, and mill room equipment. After use, tools are to be cleaned and sanitized then stored in their designated areas.
If maintenance interrupts processing, all product is to be separated from the area of maintenance and covered to prevent from contamination. All areas that have been affected by the maintenance are to be cleaned and sanitized as per the cleaning program before processing is to proceed. Any Contractors undertaking work in process areas are to sanitize their tools (alcohol spray available) before using.
Maintenance Chemicals:
Maintenance chemicals are to be:
· Stored away from factory processing rooms when not in use
· Clearly and accurately labeled
· NZFSA Approved
· Securely stored when not in use
Contract Manufacture and Analysis:
For all clients whom CMS contract manufacture for, a contract is drawn up that specifies the responsibilities of both parties. Each contract has the following content in it as a minimum:
Purpose
The purpose of this contract is to clearly establish the duties of each party for the manufacture analysis and release for sale of products under contract. It is not intended to replace liability of contract acceptors and contract givers to consumers.
Responsibilities
By signing the contract, the contract giver accepts that they have the following responsibilities to provide the contract acceptor with:
· All information necessary to carry out the contracted operations
· All the information relating to any problems associated with the product or the work which might pose a hazard / risk to the premise, equipment, personnel, other materials and other products
· All the information relating to legal requirements and market access authorizations
· With products that are suitable for intended purposes and information relating to such products, such as accompanying certificates of analysis for each individual product supplied
· If the contract giver wishes to receive product from the contract giver prior to receiving the Certificate of Analysis or microbiological results, they may do so only if the product is to be held until Certificate of Analysis and / or microbiological results have been received from the contract acceptor before the product is released for sale
By signing the contract, the contract acceptor accepts that they have the following responsibilities to ensure:
· That production and store of received product is fit for intended purpose
· Production is carried out within a premise using equipment that is suitable for the job
· Only competent persons carry out work to a satisfactory standard
· No work is passed on to a third party entrusted to them without the contract giver’s written approval
· Shall make available to the third party any manufacturing and analytical information necessary to complete the job
· Shall refrain from any activity which may adversely affect the quality of the product manufactured and/or analysed for the contract giver
· Adequate records and traceability of all products manufactured under contract and be made available within 2 working days of a request
Quarantine and Release of Finished Products:
The authorised person(s) is at present the Quality Manager. This person is independent of production and their role is to ensure that all products and materials manufactured meet the required specification and that all actions carried out are in line with regulatory requirements.
Non-conforming product may be reprocessed or reworked but only if the outcome of the reprocessing/rework will ensure compliance to specifications and regulations. Non-complying product that is not safe for human consumption is “REJECTED”. The decision of disposal is the responsibility of the customer where we don’t own the product. If it is CMS owned product, then the decision is the Quality Manager’s.
Compliance with the Marketing Authorization:
Market authorisation is when products or materials produced meet the appropriate specifications and are manufactured under approved conditions for that product. For CMS Ltd we release products for further processing only when in-house and quality control records indicate compliance to specifications and procedures.
No product or material manufactured is to be released into the market place either directly or to a distribution center unless the Authorised Person has released the product for either “Supply” where a contractual agreement between CMS and the customer accept the product under the agreement that the product will not be released to the consumer until analytical/microbiological results have been received or “Released for Sale” where ALL analytical/microbiological results have been received and the product meets it’s finished product specifications.
Releasing Finished Product to the Customer:
Products are released for sale only when all of the information relating to that product is checked and signed off by the Quality Manager. The finished product may be sent to the customer for further processing such as bottling or labeling for encapsulated/tabulated products and milling, encapsulating for dried bulk powder. This product cannot be released for sale to a distribution centre or shop until it has been approved for sale by the Quality Manager. The approval for sale by the Quality Manager includes the review of Batch Manufacturing Record’s and quality records to determine if the product is fit for intended purpose, meets defined specifications and has signed the “Certificate of Analysis”. These certificates are to be supplied along with the product for use by the customer
Product Recall & Traceability Procedure:
At the beginning of each production run, the product is subjected to a validation test to ensure that processing parameters and product specifications are met. The results are recorded in two areas: Batch Manufacturing Records and Product Log Sheet. The confirmation of the validation is carried out by Quality Control Sampling and Testing as well as analytical/microbiological analysis. The validations are carried out by Production personnel, not quality control.
