Each time a standard is updated, this results in many changes to clause references, topic names and even terminology. But does this mean, you need to update your documents to reflect this?

The recent change in the BRCGS Packaging Issue 7, where the term HACCP has been changed to HARA has meant that many sites are busy updating their documentation – for fear of getting a non-conformance if they don’t.

The change from HACCP to HARA hasn’t changed the requirements, it’s only been done to distinguish a food HACCP to a packaging HACCP. In fact, the changes in the ‘HARA’ section have now been updated so that they align with the HACCP section in food, so it doesn’t make much sense to be honest.

Although you may get the odd auditor that will want to see the name changed, most auditors won’t be worried about it – because it’s the content of the document that’s important, not what it’s called.

Spending time changing the term from HACCP to HARA isn’t going to improve your systems, so it would be time spent better doing something else.

It’s common for quality management systems to be structured around the numbering of the standard, so when the numbering changes, it often causes a great deal of admin to update the document references. Again, this doesn’t add any value and isn’t required by the standard (although we appreciate that for us techies having a mismatch in numbering can be more than we can bear!).

When are changes required?

You only need to update your systems, where a change in the standard, changes the requirements. If a term is changed, but it doesn’t change the meaning or the requirements, then you don’t need to change it.

You also need to make sure any references in your documents are accurate. If you have referenced particular clauses from the standard in your documents, you’d need to update these too. However, we would highly recommend that you refrain from making such references (unless it’s absolutely necessary such as internal audit proformas), as it just causes unnecessary admin.

How do these type of changes affect your systems? Are you about to make changes? It would be great to get a discussion going on this topic – add your thoughts to the comments below.

Have your say…

3 thoughts on “Updating documents due to changes in clause references and terminology”

  1. Simple, to the point and with so versatile use. I don’t use the BRCGS Packaging, but can see the same logic to apply to all other standards as well.
    Thank you, Kassy.

    Reply

  2. Thank you for the information provided in this article.
    I assist sites to comply with the requirements of the Standard and have been using the same numbering convention as the clauses in the Standard since the advent of issue 6. I find this to be very helpful during internal and certification audits.
    The term HARA is confusing where used in the context of the team conducting HARA and managing it. The Standard references the HARA Team, being the Team conducting the Hazard and Risk Assessment. This Team however would be the same Team managing the entire system and the term HARMS Team, as used in issue 6 would be more appropriate.
    During a recent Issue 7 audit, the auditor did query the use of HARMS. Luckily the site could provide evidence where it was defined that the HARMS Team constituted the HARA Team.
    During this audit the biggest debate was the risk assessments. Given the definition of risk assessment under “explanation of terms” on page 14 in the Standard, the auditor was looking for evidence of such risk assessments. Many of them could be provided through individual risk assessments and others through HARA. A finding was raised because documented evidence could not be provided for all risk assessments.
    Below is a list of risk assessments that I could identify from the Standard. Amendments to this list through this platform would be welcomed (if not already available).
    Risk assessment
    If the requirement says, ‘on the basis of risk’ or ‘the site shall use risk assessment’, this indicates that the first step is to carry out a risk assessment, document it, then use it to determine the company’s policy/procedure/process in order to meet that requirement.
    1 2.1.1 The hazard analysis and risk assessment (HARA) shall be developed, reviewed and managed by a multi-disciplinary team that includes those responsible for quality, technical, manufacturing operations and other relevant functions (e.g. engineering, product development).
    2 3.5.1 The frequency at which each activity is audited shall be established in relation to the risks associated with the activity and previous audit performance.
    3 3.5.5 The frequency of these inspections shall be based on risk
    4 3.6.1 The site shall have an initial approval and ongoing assessment procedure for suppliers of raw materials, including finished product packing materials, based upon risk analysis and defined performance criteria
    5 3.6.2 The initial approval procedure of manufacturing sites of raw materials that influence product safety, legality and quality shall be based on risk
    6 3.6.3 There shall be a procedure for ongoing supplier approval and performance review, based on risk and defined performance criteria
    7 3.6.4 Where ongoing supplier approval is based on questionnaires, or supplier-provided information, these shall be repeated, and traceability systems verified, at agreed intervals based on risk
    8 3.7.2 A documented vulnerability assessment shall be carried out on all raw materials, groups of raw materials or finished product packing materials to assess the potential risk of substitution, adulteration, or misrepresentation
    9 3.8.2 Where any intermediate manufacturing steps are outsourced, the risks to the safety, legality and quality of the product shall form part of the hazard analysis and risk assessment and the company’s evaluation of the outsourced manufacturing operations shall be recorded.
    10 3.9.1 Providers of utilities such as water, electricity or gas may be excluded on the basis of risk. The frequency of approval and monitoring shall be risk-based, or whenever significant changes occur
    11 4.2.5 Where they constitute a risk to product, and based on the likelihood and risk of contamination, windows and roof glazing shall be protected against breakage
    12 4.2.9 Based on risk, where elevated walkways, access steps, or mezzanine floors are adjacent to, or pass over manufacturing lines
    13 4.3.2 Based on risk assessment, the microbiological and/or chemical quality of steam, ice, air, and compressed gases which come into direct contact with product shall be specified as suitable for the intended use or regularly monitored.
    14 4.4.1 The company shall undertake a documented threat assessment of the security arrangements and potential risks to the products from any deliberate attempt to inflict contamination or damage.
    15 4.6.3 A risk-based commissioning procedure shall be in place to ensure that product safety and integrity is maintained during the installation of new or new-to-site equipment
    16 4.8.2 The frequency and methods of cleaning shall be based on risk.
    17 4.8.5 Where appropriate, and based on risk, a microbiological environmental monitoring programme shall be in place to ensure that the cleaning operations are effective in minimising the risk of contamination by micro- organisms that would be detrimental to the final products.
    18 4.9.1.2 recorded checks of condition of items, carried out at a specified frequency that is based on the level of risk to the product.
    Glass or brittle materials not in the manufacturing or storage areas shall be included in the register based on risk
    19 4.9.4.1 The plan shall be reviewed based on risk, such as changes to manufacturing operations, personnel changes, raw materials and lubricants. (Allergens)
    20 4.9.5.5 Based on risk, procedures shall be implemented to minimise other types of foreign body contamination
    21 4.11.2 The frequency of inspections shall be determined by risk assessment and documented (Pest Control)
    22 4.11.7 At appropriate intervals, the site shall request a catch analysis from flying-insect control devices to help identify problem areas.
    In the event of increase in observed or measured activity, the site shall use risk assessment to determine the action required to eliminate the hazard
    23 5.3.1 An assessment shall be carried out for the pre-press activity, print process and handling of printed product to identify:
    risks of loss of essential information
    24 5.5.3 All identified measuring equipment shall be checked and adjusted at a predetermined frequency, based on risk
    25 5.6.3 frequency of product inspection or testing and sample quantity in accordance with industry-accepted practice, or customer requirements and based on risk
    26 5.8.1 Procedures to maintain product safety, legality and quality during storage shall be risk-based,
    27 6.2.1The requirements for personal hygiene shall be based on risk assessment of the potential hazards that could occur during manufacturing and storage, and appropriate to the intended use of the finished product
    28 6.3.3 Site-issued protective clothing and personal clothing shall not be stored in the same locker or shall be appropriately segregated based on risk
    29 6.4.1 The site shall make personnel aware of the symptoms of infection, disease or condition which would prevent a person working in contact with the product. It shall be based on risk to the intended use of the finished product, or where local legislation is in place
    30 6.5.1 Based on risk assessment, and appropriate to the hazards posed to the intended use of the finished product, wearing of the following in manufacturing and storage areas, shall be considered (PPE). Where risk assessment has determined these are not required in a particular area, it shall be fully justified.
    31 6.5.5 Based on risk assessment, and appropriate to the hazards posed to the intended use of the finished product, the site shall define the rules regarding the wearing of protective clothing in all situations

    Reply

    1. Thanks for your very detailed comment Trevor. You’re quite right, where a clause states something along the lines of ‘based on risk’ this does mean, that a risk assessment is needed. I also understand why you would use the clause references for numbering of your documentation, but this does cause a huge deal of admin every time the standard changes.
      Good luck with your risk assessments! We did do a list for Issue 6, but this isn’t something we’ve had chance to do for Issue 7.
      Kassy

      Reply

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