ISO 22000 and HACCP

The first publication of ISO 22000 was by the International Organization for Standardization (or ISO). It was carried out in September 2005 and therefore the standard is referred to as ISO 22000:2005. It is recognised internationally for Food Safety Management System requirements and used throughout the food chain by orgainizations involved. Learn more about the basics of this standard and food safety.

Steps for Reviewing a Company’s HACCP Food Safety System

One of the most important aspects of HACCP food safety is making sure that you are reviewing your management staff and the system that they are using on a regular basis. Here are three steps that should be taken when you are reviewing the HACCP food safety system for your business to make sure that everything is secure.

• Review the FSMS of your organization – This means carrying out regular reviews of your FSMS and keeping records of the reviews that you have done of your system. This is an important step in HACCP food safety because it helps you to keep tabs on how the system is working.
• Examine the review inputs of management – Review information that you are given from your management team and ensure that the information will show your top managers whether the objectives which are stated in the FSMS are currently achieved.
• Generate outputs from management reviews. This is done by the following:
1 Generating actions and decisions that will assure the food product safety of the products which are falling in your company’s FSMS.
2 Generating actions and decision in order to improve your organization’s FSMS effectiveness.
3 Generating actions and decisions in order to make sure that the policy on food safety for your organization is updated.
4 Generating actions and decisions to change the objectives of your company’s FSMS.
5 Generating actions and decisions in order to address the resource needs of your FSMS.

Remember, communication in the company is very important when it comes to HACCP food safety. Everyone needs to be on the same page and the management team needs to work together to make sure that the company’s FSMS is the best that it can be. Communication and opinions from the management team can make things better for everyone.

Things that have worked in the past may become obsolete as time goes on, so that is why it’s important to do regular reviews of what you are doing in your company and see what could be changed or improved. When a management team in a company works together to think of new things that can be done, new ideas and suggestions can be hatched. Working together with a management team to help improve your company's FSMS is a step that every business owner needs to take for the good of the company.

More and more small businesses these days are achieving ISO 9001 certification. It is becoming easier and more affordable to do this because of many ‘off the shelf’ guides and manuals available for purchase over the internet. This means that companies no longer have to hire expensive consultants to help them to achieve certification. Some of the internet companies offering these products will also offer free support to assure your ISO 9001 certification.

Quality Management System - Process of implementation

The process of implementing a quality management system should start with Senior Management composing a list of Customers and Potential Customers. The process of implementing a quality management system should proceed with an organization defining the expectations and requirements of customers and potential customers. Senior Management should determine customer and potential customer requirements by market research and interviewing targeted customers to gain an understanding of their requirements.

Once the feedback has been analysed the organization should confirm with the customers to ensure understanding of their requirements is correct.Based on the defined customer requirements and potential markets the Senior Management Team should determine the requirements for the quality management system and develop relevant policies.Senior management should then consider the quality management system policies and establish the organisation’s objectives.

The quality management system processes required including resources, realization, measurement, analysis and improvement needed to achieve the objectives should be prescribed by the senior management.The management team should then identify all quality management system process inputs and outputs, including suppliers and customers. E.g. the quality management system process product realisation could have inputs including planning, training, maintenance and IT Systems, and outputs to distribution and customer.

Next the senior management team should define and describe the quality management system processes and their interaction, considering the supplier and customer of each process, inputs and outputs of each process, which processes are interacting, the timing and sequence of the processes, the effectiveness and efficiency of the sequence.A flowchart is an easy way to show the sequence of processes and their interactions.Individual responsibilities for ensuring the implementation, maintenance and improvement of each quality management system process should be assigned by the senior management team. E.g. the Planning Manager would normally be the planning process owner with responsibility in the quality management system would be for implementing, maintaining and improving the planning process and interacting effectively with sales and production processes.The Planning Manager objectives should be in line with quality management system objectives for example 100% Accurate Production Plan, 100% Order Completion, and less than 1% Wastage.The next step is to establish a Process Management team that has an overview across all the quality management system processes, and includes process owners from each of the processes.

The process management team should then assess each quality management system process and determine any documentation required and the most effective method of managing the process.

Different methods of documentation can be used, the team should decide which is best to represent and comprehend the quality management system process. The process management team should then undertake a project implementing the quality management system processes and their activities as planned that including communication, awareness, training, change management, management involvement and review activities.

The quality management system processes and the intended process outputs should be subjected to monitoring and measurement for both control and improvement purposes. Measurement and monitoring to determine the effectiveness and efficiency of the quality management system process is a powerful management tool. At this stage there should be corrective and preventative actions taken as per the documented quality management system procedure. This should include the identification and elimination of the root causes and potential causes of the problems such as defects or lack of adequate process controls.

The next stage is to identify improvement opportunities for the quality management system based on the results of the analysis of process information.Finally, confirm that the characteristics of the quality management system processes are consistent with the purpose of your organisation.

Management Review of the Quality Management System

ISO 9001 Certification Requirements: Management Review of the Quality Management System

Regular Management reviews should conducted in order to assess the effectiveness of the Quality Management System and to continually improve. Quality Management System reviews should involve the Senior Management. The Management Representative will normally carry out most of the preparation work for the review but may request that each department representative prepares quality management system information for review. The scope of the Management Review should include all process activities conducted on site and any sub-contracted activities.

Senior management should review the company quality management system at a minimum annually. The purpose of the review is to ensure the continuing suitability, adequacy and effectiveness of the quality management system. The review should include assessing opportunity for improvements and the need for amendments to the systems. The proceedings of all quality management system reviews should be documented.

The management review meeting is normally chaired by the most Senior Manager such as the Managing Director. Senior Management representing each department in the organisation should be present including the nominated Management Representative.

The management review meeting should have an agenda including all the key quality management system items for review and opportunities for input from all the participants.

There should be clear Management Review Objective outlined at the start of the quality management system review. A typical objective would be to review and assess the effectiveness of the Quality Management System and to initiate corrective and preventative actions should they deemed to be necessary and to seek potential opportunities to improve the effectiveness of the quality management system and exceed customer requirements.

For each item on the agenda there should be an analysis of performance or review of suitability and comments or details of the findings and plans for corrective action, preventative action or opportunities for improvement of the quality management system, all of which should be documented in the minutes.

The first item on the management review agenda really should be a review of the Quality Policy to confirm it is pertinent to the quality management system and organisation or if any changes are required. Similarly the Quality Objectives should be reviewed and updated as necessary. There should be a review of the Management Structure and any changes and confirmation that there is adequate quality management system resource.

The meeting should cover the minutes and follow-up actions from previous review meetings and confirm actions to improve the quality management system as a result of the review have been completed.

Findings of internal and external quality management system audits should be reviewed and outstanding non-conformances as a result of internal and external quality management system audits discussed. The Management Representative should conduct a trends analysis of the results of internal and external audits to present to the meeting. The management review team should also ensure that internal quality management system audits have been carried out as planned. Adverse trends such as an increased number of non-compliances should be identified and corrective action proposed. The results of third-party quality management system audits should be thoroughly scrutinised as these represent and independent view of the organisation.

The Quality Manager should present a trend analysis of Customer Complaints. This data should compare year on year performance especially when a product or service is seasonal. Volumes should be factored into the complaints analysis and so complaints should be presented taking this into consideration. Complaints are should also be categorise into critical and non-critical. Non-critical and total complaint analysis is useful for trends. Critical complaints should be closely analysed to determine if there is a common cause and if effective corrective action has been taken.

A standard format is to compare complaints per million units sold for each product. Industry standard complaint levels should be used for comparison. Again trends should be identified and if necessary plans for preventative action taken. Complaint analysis should also give an indication of opportunities for improvement of the quality management system. At this stage Safety incidents, recalls or withdrawals should also be reviewed. Corrective Action should have already been taken to deal with the causes of these incidents, the meeting should review the effectiveness of the quality management system in eliminating the cause of the incidents and also consider any common factor to the incidents in order to assess if preventative actions are required to improve the quality management system.

The meeting should review the quality management system Approved Supplier Register. A review of annual supplier performance should be presented normally by the Purchasing Manager. The report should include items such as percentage on time deliveries, percentage order completion, any non-conformances such as damaged deliveries or non-conforming products supplied plus any products rejected or accepted under concession. The report should also recognise exceptional supply performance and added value assistance received from suppliers as this should be factored into the quality management system when renegotiating contracts. Corrective Action plans should be formulated to deal with or change poor performing suppliers. Similarly to Customer Complaints, Supplier complaints should be analysed for trends.

The management review meeting should discuss quality management system process performance and confirm that the correct performance indicators are being monitored. Review and analysis of the quality management system Key Performance Indicator trends should be conducted to see if there is a visible improvement in performance. Sales levels should be one of the quality management system Key Performance Indicators as this will give an indication of company performance in the market place. Also the number and performance of new products successfully launched into the market place should be discussed. Again corrective action, preventative action and opportunities for improvement of the quality management system should be considered from the key performance indicator trend analysis.

The management review should cover the status of corrective and preventive action and compare numbers since the previous review and consider if the quality management system corrective and preventative actions are being completed in a timely fashion.

There should conduct a review of changes within the organisation and how this may have affected resource requirements including infrastructure, work environment, personnel and training requirements. At this stage proposed changes should be discussed and again quality management system resource requirements identified.

Review should also include Environmental performance and incidents,

and Health and Safety performance and accidents

The Management Review outputs should include corrective and preventative actions identified as a result of analysis of the quality management system review inputs, all of which should be clearly documented in the minutes.

There will also be opportunities for Improvement in quality management system effectiveness including product quality enhancement, change or elimination of non-productive elements, change or elimination of non-productive systems or procedures and supply of resource needed for improvement plans.

The results of the Management Review meetings should be documented in the minutes of the meeting and include a summary of all quality management system review inputs and outputs. The Management Representative should ensure the minutes of the Management Review meeting are distributed and effectively cascaded within the organisation.

In additional to the formal Management Review an organisation should consider other review activities to monitor the effectiveness of the quality management system including a daily management meeting to review recent performance and issues arising by exception, Key Performance Indicator Reviews to review previous performance in quality, wastage and customer service, Environmental performance review, Health & Safety performance review, HACCP review and Quality Review.

Annual Complaints Analyser

The report calculates your complaints per million units for the month by product and category and has a colour coded alert level which you can preset.

The system will automatically update your annual report so you can monitor complaints in a year to date format again with colour coded alerts.

Annual Complaints Analyser

Quality Management System Requirements

ISO 9001:2008 Quality Management System Requirements

The new revision of the ISO 9001 standard has been simplified so that it is equally applicable to the quality management system of small as well as medium and large organizations. ISO 9001:2008 allows flexibility in the way you document your quality management system.

Clause 4.2.1 General explains that the quality management system documentation shall include:

- Quality policy

- Quality objectives

- Quality manual

- documented procedures required by the Standard

- documents needed by the organisation to ensure the effective planning, operation and control of its processes, and records required by the Standard

It also emphasizes that the extent of quality management system documentation may differ due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel. Larger organizations or those with more complex processes usually require a more extensive quality management system.

It is sometimes convenient to combine the procedures for several activities into a single documented procedure in a quality management system, for example, corrective action and preventive action are commonly combined.

Below we make suggestions as to how you can combine activities and ISO 9001:2008 requirements in your quality management system. We also outline the records required although they do not necessarily have to be in your quality management system.

Your quality management system must contain your Quality policy objectives.

Your quality management system must have a procedure for the control of documents and the control of records. These could be combined to include the requirements of Documentation (Clause 4.2.3), Internal Document Control (Clause 4.2.3), External Document Control (Clause 4.2.4) and Quality System Records (Clause 4.5) into one quality management system document.

Your quality management system must have a procedure for Internal Audit (Clause 8.2.2) a record of results and follow up actions is also required.

Your quality management system must have a procedure for Control of Non-Conforming Product (Clause 8.3) a record of the results and follow-up actions is also required.

Your quality management system must have a procedure for the Corrective action and Preventive action. These could be combined to include all the requirements of clause 8.5 Corrective Action, Preventive Action and Improvement in one quality manual document. Records of the results of corrective action (8.5.2 e) and results of preventative action (Clause 8.5.3 d)) are also required.

Management Commitment (Clause 5.1), Customer Focus (Clause 5.2), Planning (Clause 5.4) Responsibility & Authority and Internal Communication (Clause 5.5), and Management Review (Clause 5.6) could all be combined into one document in your quality management system. Please note that records of Management Review are also required (Clause 5.6.1).

Resources (Clause 6.1), Human Resources & Training (Clause 6.2) Infrastructure (Clause6.3) and Work Environment (Clause 6.4) could be combined into one document procedure in your quality management system. There is also a requirement to record education, training, skills and experience of personnel (Clause 6.2.2 e)).

Planning (Clause 7.1) and Customer Related Processes (Clause 7.2) are not required to be documented in your quality management system but Clause 7.2.2 requires a record of the results of the review of customer requirements prior to supply and evidence that the realization processes and resulting product fulfill requirements (Clause 7.1 d) so a single contract review procedure would be prudent.

There is a requirement for Design and Development records (Clause 7.3.2 -7.3.7) to be maintained so a matching procedure in your quality management system would be sensible.

Purchasing, Orders and Verification of Purchased Materials (Clause 7.4) does not require a documented procedure in your quality management system but the results of supplier evaluations (Clause 7.4.1) need to be recorded

Production (Clause7.5.1), Validation of Processes (Clause7.5.2), Identification and Traceability (Clause 7.5.3), Customer Property (Clause 7.5.4) and Preservation of Product (Clause 7.5.5) could be combined into a single procedure in your quality management system. Records are required to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement (Clause 7.5.2 d), the identification and traceability of the product (Clause 7.5.3) and for Customer property that is lost, damaged or otherwise found to be unsuitable for use (Clause 7.5.4).

Again there is no requirement for a document calibration procedure in your quality management system but records are required for the basis used for calibration or verification of measuring equipment where no international or national measurement standards exist (Clause 7.6 a),

Validity of the previous measuring results when the measuring equipment is found not to conform to requirements (Clause 7.6) and results of calibration and verification of measuring equipment (Clause 7.6). As calibration is usually critical to ensure conformity to requirement we would highly recommend you have a documented procedure in your quality management system.

Monitoring and Measurement (Clause 8.2), Customer Satisfaction (Clause 8.2.1), and Analysis of Data (Clause 8.4) could be combined into a single document in your quality management system. A record is also required to indicate the person authorising release of product (Clause 8.2.4).

There are several other requirements of ISO 9001:2008 where you could add value to your quality management system and demonstrate conformity by the preparation of other documents.

Process flow charts are useful quality management system tools as they present a clear visual representation. It is also normal for a quality manual to contain an Organization diagram showing clear lines of responsibility and authority and nominated deputies. Specifications can be contained in the quality management system and are useful reference documents. Work instructions are an essential element of a quality management system especially for processes critical to quality. A quality management system should contain Approved supplier lists to demonstrate compliance with Clause 7.4 purchasing.

Inspection plans and Quality plans would normally be included in the quality management system.

For more details about implementing a quality manual and quality management system visit our website www.iso9001manual.com and see our Assured ISO9001 Certification Package which contains an ISO9001:2008 compliant Quality Manual template and ISO9001 Quality Management System implementation guides.