Q) We are ISO 9001 certified and we have a quality manual, as required by the Standard. Now we're adding environmental management to our system. I thought we'd need to create a separate 'environmental manual.' But in looking over ISO 14001, I don't see where an environmental manual is required. What am I missing?

A) Neither ISO 14001 (nor, for that matter, OHSAS 18001, the health/safety standard) require a top-level ("Level 1") manual the way ISO 9001 does (4.2.2). ISO 14001 and OHSAS 18001 do require many of the items you'll find in 9001, such as the policy statement and system scope. But you can document these separately or together or in any other manner you find most suitable.

Q: How consistent do organization charts have to be with the titles / functions mentioned in procedures and work instructions?

A: They must be completely consistent. This is not to say that an organization chart must list every single function of the organization. Some summarization / consolidation are acceptable here in the interest of clarity. But job functions, titles, etc. must be consistent across the entire system - organization chart, procedures, work instructions, training plans / records, job descriptions (though job descriptions as such are not specifically required and, in fact, are not always desirable).

Q: If we keep obsolete versions of ISO documents on computer (so that revision history can be tracked), do we need hard copy also? Can we destroy all obsolete hard copies?
A: Yes. There is no earthly reason to keep obsolete hard copies of they are available electronically.
Q: The Standard talks about control of documents of external origin. My question deals with the words Applicable & Standards. We do great job in controlling customer drawings, but for the standards and codes we are unsure how to define which ones we need to control. Any thoughts?
A: Any externally generated document that you use in your facility that does, or can, affect the quality of the product/service going to the customer, must be controlled. Control means, first of all, having a process for assuring that what you're using is the source's latest approved version. Control also means that, if you copy and circulate the document internally, you have the means to assure that only the latest approved version is in use.
Q: Does the ISO 14001:2004 standard's requirement for awareness training of employees pertains to all employees or only those whose jobs bear some relationship to environmental aspects and impacts?
A: ISO 14001, Section 4.4.2, does not specify that "all" employees must receive "awareness training". Rather, it states that "employees at each relevant function and level" must be made aware of the items listed in paragraphs (a) through (d) of Section 4.4.2. This can be accomplished by various means such as by training or some other means identified in the organization’s established procedures (eg: meeting, memo). However, the first paragraph of Section 4.4.2 also states that "(the organization) shall require that all personnel whose work may create a significant impact upon the environment, have received appropriate training."This allows the organization to determine for itself which employees are in "relevant" areas. It is likely that such employees will have jobs with the potential for environmental impact. However, "awareness" and "training" does not have to be limited to such employees.
Q: Most companies that are certified with ISO 9001 have so many procedures and records.  Do we need to have so many procedures and records for implementing ISO 9001?  Can we cut down the number of procedures and records?

A: Most companies have a common misconception of ISO 9001 as a set of documentation requirements.  ISO 9001 did specify the requirements on certain documents and records, the main intention and focus of the standard is not documentation.  In fact, very few documents are specifically required by ISO 9001.  Following is a list of all ISO 9001 required documents and records:



ISO 9001 required documents



Document Control



Record Control



Internal Audits



Control of Non-Conforming Product (or Service)



Corrective Action



Preventive Action




ISO 9001 required records



Management reviews


6.2.2 (e)

Education, training, skills and experience


7.1 (d)

Evidence that the realization processes and resulting product fulfill requirements



Results of the review of requirements related to the product and actions arising from the review



Design and development inputs relating to product requirements



Results of design and development reviews and any necessary actions



Results of design and development verification and any necessary actions



Results of design and development validation and any necessary actions



Results of the review of design and development changes and any necessary actions



Results of supplier evaluations and any necessary actions arising from the evaluations


7.5.2 (d)

As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement



The unique identification of the product, where traceability is a requirement



Customer property that is lost, damaged or otherwise found to be unsuitable for use


7.6 (a)

Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist



Validity of the previous measuring results when the measuring equipment is found not to conform to requirements



Results of calibration and verification of measuring equipment



Internal audit results and follow-up actions



Indication of the person(s) authorizing release of product.



Nature of the product nonconformities and any subsequent actions taken, including concessions obtained



Results of corrective action



Results of preventive action

From the table above, there are only six documented procedures that are required by the ISO standards.  Most records as specified above are records that should have been in place even before ISO implementation.  The records specified are for proper management of the processes.  Records that should have been in place are as below:-

a)      products/services provided are monitored to ensure they are meeting the customers’ requirements.

b)      personnel authorizing for release are identified.

c)      customers’ requirements are reviewed to ensure the organization can meet their specified requirements.

d)      all stages of the design and reviewed, verified and validated to ensure the produce is able to achieve the expected performances.

e)      the measuring equipments are able to measure according to the required tolerance.

f)        products are with proper identification and traceablity to ease the identification of the root causes of the problem where any defects are identified.

Besides, company itself can include other procedures & records which applicable and necessary to ensure the effective planning, operation and control of its processes (eg: Maintenance procedure, Management Review procedure, and etc).

In actual fact, when implementing ISO 9001 it is more to tidying up and standardize the flow for each process.  Standardization will help the organization to have a common understanding on how each flow should be processed.  It will also enable the organization to have a system to record on what actually had happened during the time of production. 

With all the standardized documented procedure and records in place, determination of the actual root cause of the problem will be feasible to enable proper corrective actions to be taken and thereafter continuously improve the management of processes in the organization. Records requirement per ISO 9001 such as management reviews, internal audits, corrective and preventive actions shall be recorded to show evidence that the improvement actions are taking place.

Where an organization is implementing ISO 9001 solely for the purpose of gaining access to the customers or the markets and not with the main intention to continually improve the processes in the organization, the process of implementing ISO 9001 will be deemed as “many documentation and record required”
Q. What is HACCP?
A. HACCP, or the Hazard Analysis Critical Control Point system, is a process control system that identifies where hazards might occur in the food production process and puts into place stringent actions to take to prevent the hazards from occurring. By strictly monitoring and controlling each step of the process, there is less chance for hazards to occur.

Q. Why is HACCP Important?

A. HACCP is important because it prioritizes and controls potential hazards in food production. By controlling major food risks, such as microbiological, chemical and physical contaminants, the industry can better assure consumers that its products are as safe as good science and technology allows. By reducing food borne hazards, public health protection is strengthened. With HACCP certification, it will assist in branding the products as well as providing consumer with better confidence with our product.
Q. What are the Major Food Hazards?
A. While many public opinion studies report that consumers are concerned primarily about chemical residues, such as from pesticides and antibiotics, these hazards are nearly non-existent. The more significant hazards facing the food industry today are microbiological contaminants, such as Salmonella, E. coli O157:H7, Listeria, Campylobacter, and Clostridium botulinum. Apart from that, physical hazards like metal fragments and wood fragments are the other examples type of major hazards. In other words, HACCP is designed to focus on and control the most significant hazards.
Q. Is HACCP New?
A. HACCP is not new. It was first used in the 1960s by the Pillsbury Company to produce the safest and highest quality food possible for astronauts in the space program.
Q. How Does HACCP Compare to the Current Food Production and Inspection Programs?
A. The current food inspection program is based on a "see, smell and touch" approach that relies more on detection of potential hazards than prevention. Furthermore, the current inspection program was designed in the 1930s when the threat of diseased animals and physical contaminants were the main concerns. Today, microbiological and chemical contaminations, which cannot be seen, are of greater interest.
Q. How Does HACCP Work in Food Production?

A. There are 7 principles that serve as the foundation for a HACCP system:

1. Conduct a hazard analysis to identify potential hazards that could occur in the food production process.

2. Identify the critical control points (CCPs) -- those points in the process where the potential hazards could occur and can be prevented and/or controlled.

3. Establish critical limits for preventive measures associated with each CCP. A critical limit is a criterion that must be met for each CCP. Where appropriate, critical limits may reflect relevant FSIS regulations and FDA tolerances.

4. Establish CCP monitoring requirements to ensure each CCP stays within its limit. Monitoring may require materials or devices to measure or otherwise evaluate the process at CCPs.

5. Establish corrective actions if monitoring determines a CCP is not within the established limits. In case a problem occurs, corrective actions must be in place to ensure no public health hazard occurs.

6. Establish effective recordkeeping procedures that document the HACCP system is working properly. Records should document CCP monitoring, verification activities and deviation records.

7. Establish procedures for verifying that the HACCP system is working properly. Verification procedures may include reviewing the HACCP plan, CCP records, critical limits as well as conducting microbial sampling. Verification activities shall be conducted as well.
Q. Apart from HACCP, What are the other food safety certification alternatives?
A. Current there quite a number of food safety certifications namely, ISO 22000 (Food Safety Management System), SQF 2000, BRC Global Standard For Food Safety as well as FSSC 22000.
Q. What are the core fundamentals to establish food safety system like HAACP?

A. The core fundamental is the commitment from the top management to support by providing necessary resources needed e.g. personnel, training, facilities, infrastructure & work environment. In addition, it is vital to establish HACCP Team which lead by HACCP Coordinator/ Team Leader to ensure the system is in accordance and continuous improve if necessary.

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