Is a Written Procedure Required for Existing Products According to BRCGS Clause 5.1.1?

Hi all,

We are a small confectionary. 

BRCGS auditor says we must have a written procedure for new product development (claus 5.1.1). I stated we do not have R&D or make any changes to our product. Then they asked for a procedure for existing items. 

 

We do not have such documents or recipes written. Is this a requirement? 

um.............how do you batch without a written recipe?

 

Short answer is YES!  if you don't have a written recipe-you could lose traceability (in theory) because you don't know how much of an ingredient you've used and when

 

Batch records???

Thanks Scampi.

We have batch records. Do the procedures have to be thorough - step by step  - including temperature and all? 

Without a recipe, how do your employees know how to make your product?

 

 

Speaking from your new product development statement here, I've had multiple instances where a code item doesn't apply because "we don't do that."  Auditors still (rightfully) expect you to have something addressing the clauses.  In your shoes, I would create a New Product Development policy that basically states your company does not anticipate needing to develop any new products, but if you did, an SOP would be created to address all of the steps you would perform (HACCP review, shelf life, recipe and process development, etc).  This worked for me under SQF schemes.

Yes, you should have the process and ingredient quantities written down somewhere

 

Not sure how you train or even produce a batch record when seemingly don't have anything to follow

It's only 3-4 ingredients. Operators were given verbal instructions when they started 15-20 years ago. It's the same thing everyday. 

Batch records show how much of each ingredient went in. Chocolate making is different than everything else ;) 

Then it should be quick and easy!

 

I've done some time in chocolate---just make sure your tracking your rework appropriately  

I remember auditing a bakery under SQF. LOTS of things were missing because most things including product development, recipes. etc were VERBAL.

 

Verbal don't make it so is what the owner kept saying after I had noted multiple docs missing because most things were done old school by verbal only.

 

Everything gets documented

. 

Hi kconf,

 

I would draw up a brief procedure for new product development and changes to existing product, packaging and manufacturing processes should these ever occur. This needs to state that new products/changes are to be formally approved by the HACCP team leader or an authorised HACCP team member and that production and shelf-life trials are conducted.

 

Your receipes need to be documented as well, if you look at 6.1 Control of operations section 6.1.1, it states:

Documented process specifications and work instructions/procedures shall be available for the key processes in the production of products to ensure product safety, legality and quality. The process specifications and work instructions/procedures (as appropriate) shall include:

• recipes – including identification of any allergens

• mixing instructions, speed, time

etc….

Process specifications shall be in accordance with the agreed finished product specification.

 

Kind regards,

 

Tony

should have methods in place & full traceable production/batch records?

 

What do you do for your "mock" recalls?

How does it impact mock recalls? 

How do you know how much of a product to recall if you don't have a list of the ingredients that went into the product? Do you even make more than one product in a day?

2.12.2

Procedures of verification shall be established to confirm that the HACCP or food safety plan, including controls managed by prerequisite programmes, continues to be effective. Examples of verification activities include:

• internal audits
• review of records where acceptable limits have been exceeded
• review of complaints by enforcement authorities or customers
• review of incidents of product withdrawal or recall.

Results of verification shall be recorded and communicated to the HACCP food safety team.

 

3.7

Corrective and preventive actions

Fundamental

SOI

The site shall be able to demonstrate that it uses the information from identified issues in the food safety and quality management system (e.g. non-conforming products, internal audits, complaints, product recalls, product testing, second- and third-party audits and online reviews) to complete necessary corrective actions and prevent recurrence.

 

3.11

3.113.1

Management of incidents, product withdrawal and product recall

SOI

The company shall have a plan and system in place to manage incidents effectively and enable the withdrawal and recall of products should this be required.

 

3.11.2

3.11.2

The company shall have a documented product withdrawal and recall procedure. This shall include, at a minimum:

• identification of key personnel constituting the recall management team, with clearly identified responsibilities
• guidelines for deciding whether a product needs to be recalled or withdrawn and the records to be maintained
• an up-to-date list of key contacts (including out-of-hours contact details) or reference to the location of such a list (e.g. recall management team, emergency services, suppliers, customers, certification body, regulatory authority)
• a communication plan including the provision of information to customers, consumers and regulatory authorities in a timely manner
• details of external agencies providing advice and support as necessary (e.g. specialist laboratories, regulatory authority and legal expertise)
• a plan to handle the logistics of product traceability, recovery or disposal of affected product, and stock reconciliation
• a plan to record timings of key activities
• a plan to conduct root cause analysis and to implement ongoing improvements, to avoid recurrence.

The procedure shall be capable of being operated at any time.

 

3.11.3

The incident management procedures (including those for product recall and withdrawal) shall be tested, at least annually, in a way that ensures their effective operation. Results of the test shall be retained and shall include timings of key activities. The results of the test and of any actual recall shall be used to review the procedure and implement improvements as necessary.

 

3.11.4

In the event of a significant food safety, authenticity or legality incident, including a product recall, regulatory food safety non-conformity (e.g. a regulatory enforcement notice) or food safety-related withdrawal, the certification body issuing the current certificate for the site against this Standard shall be notified within 3 working days.

The company shall then provide sufficient information to enable the certification body to assess any effects of the incident on the ongoing validity of the current certificate within 21 calendar days. As a minimum, this shall include corrective action, root cause analysis and a preventive action plan.

 

3.5.1.6

The company shall ensure that its suppliers of raw materials (including primary packaging) have an effective traceability system. Where a supplier has been approved based on a questionnaire instead of certification or audit, verification of the supplier’s traceability system shall be carried out on first approval and then at least every 3 years. This may be achieved by a traceability test.

Where the supplier is not the manufacturer, packer or consolidator of the raw material (e.g. purchased from an agent, broker or wholesaler) and approval is based on a questionnaire instead of certification or audit, the verification of the traceability system shall be carried out on the last manufacturer, packer or consolidator of the raw material.

Where a raw material is received directly from a farm or fish farm, further verification of the farm’s traceability system is not mandatory.

 

 

How can you perform a "mock" recall if you do not know the ammounts/batches added to each run .

 

Assume you use the JULIEN calander for daily batch codes - IE L4001 is 01-01-24?

 

Couple clauses relating to TRACEABILITY ---- Will be a MAJOR if you cannot show evidence of at least x2 traceability studies Forwards & Backwards...

More if you make claims ie GF or Low-salt....

How does it impact mock recalls? 

3.9

Traceability

Fundamental

SOI

The site shall be able to trace all raw material product lots (including primary packaging) from its suppliers through all stages of processing and dispatch to its customers and vice versa.

Clause

Requirements

 

3.9.1

The site shall have a documented traceability procedure designed to maintain traceability throughout the site’s processes. At a minimum this shall include:

• how the traceability system works
• the labelling and records required.

 

Where applicable, the traceability system shall meet the legal requirements in the country of sale or intended use.

 

3.9.2

Identification of raw materials (including primary packaging), intermediate/semi-processed products, part-used materials, finished products and materials pending investigation shall be adequate to ensure traceability.

 

3.9.3

The site shall test the traceability system across the range of product groups to ensure traceability can be determined from the supplier of raw material (including primary packaging) to the finished product and vice versa. For food raw materials and finished products (i.e. including printed packaging and labels with food safety and legal information), the test of the traceability system shall include a quantity check/mass balance.

The traceability test shall include a summary of the documents that should be referenced during the test, and clearly show the links between them. The test shall occur at a predetermined frequency, at a minimum annually, and results shall be retained for inspection. Traceability should be achievable within 4 hours.

 

How do you know how much of a product to recall if you don't have a list of the ingredients that went into the product? Do you even make more than one product in a day?

We do have batch records.

We have been able to perform traceability without a problem. Here's how it goes.

Operators record ingredient name, lot # , amount on  batch datasheet.

Like I said, there are only 3-4 ingredients in our products, which are also listed on our spec sheets. 

So the "production sheet" is where you record down the batch ###

 

But how do operators know order to add ingredients?

Mixing/heating times?

You need a recipe to identify where you may have need for CCP's or RPR's to ensure safety/quality...

If an auditor has raised as NC, best just to close out within the 28 days to ensure site certification does not lapse.

And then do futhur work...

 

always continuous improvement ... one of BRC's catch phrases