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Controlled Documents vs. non-Controlled Documents

Document Control

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xylough

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Posted 03 June 2015 - 09:05 AM

Esteemed Forum Members,

 

Please be so kind to answer me this: With respect to document control for the GFSI benchmarked schemes, what is the delineation between the documents that SHALL be controlled and those documents that do not require control?

I don't mean a list of controlled documents and non-controlled document, but rather what is the logical argument for what is or is not controlled? I certainly do not want the extra burden of controlling documents that don't really require it.

 

Kind regards,

 

xylough



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Rosemary4

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Posted 03 June 2015 - 01:22 PM

Controlled and uncontrolled documentation and identification is/are however a company defines them in their own QMS..

Any systems to work well, the document(s) need to be controlled. It is the responsibility of the user to ensure that he/she
uses the latest.

A document is uncontrolled when printed. You could put a disclaimer in the footer of the documents “If Printed, Uncontrolled”. Quality documents (i.e. Quality Manuals, Procedures etc.) are always controlled. Changes to formal documents such as a Quality Manuals or Procedures can only be done through raising a formal change request. Once a change has been approved and applied to a formal document the version is incremented. All this should be detailed in you Quality / Document Management Manual or Document Management Procedure.



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Charles.C

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Posted 03 June 2015 - 02:25 PM

hi xylough,

 

I don't know about GFSI but  BRC defines their "controlled documents"  -

 

Controlled document - A document which is identifiable and for which revisions and removal from use can be tracked. The document is issued to identified individuals and their receipt of the document is recorded

 

The (BRC) choice of which documents are to be "controlled" or not is apparently open as long as this general requirement is achieved -

 

The company shall operate an effective document control system to ensure that only the correct versions of documents, including recording forms, are available and in use.

 

(Plus some Procedural details).

 

not sure if that answers yr query ffom BRC's POV.

 

IMEX, the "Uncontrolled if Printed" is quite popular these electronic days.

 

I also noted this comment elsewhere -
 

 

The bottom line is ISO is a guideline! It is up to each particular organization to determine and design the doc control system that works best for them.

Controlled and uncontrolled documentation and identification is/are however a company defines them in their own QMS. While general doc control systems may be basically similar in many respects, no two are exactly alike.

 

 


Kind Regards,

 

Charles.C


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CMHeywood

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Posted 09 June 2015 - 06:48 PM

May depend on how fussy your auditor/certification body is.  Our SQF/NSF auditor wanted to see controlled documents for anything listed or referenced in our Quality Manual and Food Safety Manual.



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Charles.C

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Posted 10 June 2015 - 03:44 AM

May depend on how fussy your auditor/certification body is.  Our SQF/NSF auditor wanted to see controlled documents for anything listed or referenced in our Quality Manual and Food Safety Manual.

 

The appropriate answer is "Show me where requested by the Standard"


Kind Regards,

 

Charles.C


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Tony-C

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Posted 10 June 2015 - 06:03 AM

Please be so kind to answer me this: With respect to document control for the GFSI benchmarked schemes, what is the delineation between the documents that SHALL be controlled and those documents that do not require control?

 

Kind regards,

 

xylough

 

Hi xylough,

 

Interesting question!

 

As a general rule I would say documents (including records) pertaining to legality, quality and safety must be controlled. For BRC you can add documents relating to authenticity.

 

GFSI mention compliance with the standard and food safety. GFSI benchmarking requires that 'The standard shall require that documentation procedures are in place to demonstrate compliance with the standard and ensure that all records required to demonstrate the effective operation and control of its processes and its management of food safety....'

 

So it is down to the specifics of the scheme that you choose.

GFSI Guidance Document
Section 1: Food and Feed Safety Management Requirements
Table I – Food Safety Management Requirements
Scopes of Recognition AI, AII, BI, BII, C, D, EI, EII EIII, EIIV and L
FSM 3 Food safety manual
The standard shall require the organisation has a Food Safety Manual or documented system having a scope appropriate to the range of business activities to be covered, including documented procedures or specific reference to them and describing the interaction of the related process steps.
FSM 8 General documentation requirements
The standard shall require that documentation procedures are in place to demonstrate compliance with the standard and ensure that all records required to demonstrate the effective operation and control of its processes and its management of food safety are securely stored for a time period required to meet customer or legal requirements, effectively controlled and readily accessible when needed.
FSM 10 Procedures
The standard shall require that the organisation establish, implement and maintain detailed procedures and instructions for all processes and operations having an effect on food safety.

 

Here are some key elements from the main for schemes for food manufacturers:

 

BRC Global Standard for Food Safety Issue 7
3.2 DOCUMENTATION CONTROL
The company shall operate an effective document control system to ensure that only the correct versions of documents, including recording forms, are available and in use.
3.2.1 The company shall have a procedure to manage documents which form part of the food safety and quality system.
Interpretation
Documents must be effectively controlled to ensure that staff are working with the most up-to-date information and to minimise the potential for mistakes. Documents include policies, procedures, work instructions, records, forms, specifications, data lists etc. and information that is written down and defined. They may be available on paper (i.e. as ‘hard copy’) or in electronic format.
Key documents found to be in use during the audit and which are not properly authorised or of the correct version may lead to a non-conformity.
In order to demonstrate the control of document issue, it is necessary to maintain a register of all controlled documents, their allocation and issue status. Where the controlled documents are all contained on an electronic system, it is usual for printed versions to be marked uncontrolled. Each copy must be authorised (e.g. with a signature or stamp) to show it is for use, and each must be given a version number so that out-of-date documents can be identified and removed. This must be evidenced by the fact that all documents in use are the most up-to-date version.
3.3 RECORD COMPLETION AND MAINTENANCE
The site shall maintain genuine records to demonstrate the effective control of product safety, legality and quality.
Interpretation
Records are documented information that provides permanent evidence about past events – particularly events concerning product safety, quality and legality. Records must therefore be maintained in an appropriate way to ensure they demonstrate control of systems and operations.



SQF Code Edition 7.2
2.2 Document Control and Records
2.2.1 Document Control (M)
2.2.1.1 The methods and responsibility for maintaining document control and ensuring staff have access to current documents shall be documented and implemented.
2.2.1.2 A register of current SQF System documents and amendments to documents shall be maintained.
2.2.1.3 Documents shall be safely stored and readily accessible.
2.2.2 Records (M)
2.2.2.1 The methods and responsibility for undertaking monitoring activities, verifying, maintaining and retaining records shall be documented and implemented.
2.2.1 Implementation Guidance
What does it mean?
This element relates back to 2.1.3 Food Safety and Quality Management System. All management system documents (e.g., policies, procedures, specifications, food safety plans, food quality plans, work instructions), plus any other operational reference documents (e.g., external codes, regulations, customer requirements, equipment instructions, etc.), must be controlled to ensure their currency and relevance. This includes forms which are the templates for records that are used to report test, inspection and audit results.
A register of all documents must be maintained including when they were issued, updated and who has a copy of each document. Documents referred to include, for example, pre-requisite programs, food safety plans, food quality plans, SSOPs, SOPs, other work instructions and raw material and finished product specifications, etc.


This is where SQF can cause confusion because in theory to achieve Level 2 and the GFSI benchmarked certification you do not need to control documents pertaining to quality:

LEVEL 2 Food Safety Plan (accredited certification, GFSI recognition)
2.1.3 Food Safety Management System (M)
2.1.3.1 A food safety manual shall be documented and maintained in either electronic and/or hard copy form.
LEVEL 3 Food Quality Plan (accredited certification, GFSI + Quality Management)
2.1.3 Food Safety and Quality Management System (M)
2.1.3.1 A food safety and quality manual shall be documented and maintained in either electronic and/or hard copy form.



IFS Food V6
2 Quality and Food Safety Management System
2.1 Quality Management
2.1.1 Documentation requirements
2.1.1.1 The system for food safety and quality management shall be documented and implemented, and shall be retained in one location (food safety and quality manual or electronic documented system).
2.1.1.2 A documented procedure shall exist for the control of documents and their amendments.
2.1.1.4 All documents which are necessary for compliance with the product requirements shall be available in their latest version.
2.1.2 Record keeping
2.1.2.1 All relevant records necessary for the product requirements* shall be complete, detailed and maintained and shall be available on request.
2.1.2.2 Records shall be legible and genuine. They shall be maintained in a way that subsequent manipulation of records is prohibited.
* 1.1 Corporate policy/Corporate principles
1.1.1 The senior management shall draw up and implement a corporate policy. This shall consider as a minimum:
– product requirements (includes: product safety, quality, legality, process and specification).



FSSC 22000
The current benchmarked scheme doesn't cover quality:
ISO 22000:2005
4.2.2 Control of documents
Documents required by the food safety management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.3.
The controls shall ensure that all proposed changes are reviewed prior to implementation to determine their effects on food safety and their impact on the food safety management system.
4.2.3 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and evidence of the effective operation of the food safety management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.


There is a quality element which was added this year based on compliance with ISO 9001:
To meet this wish the Board of Stakeholders decided on 24 February 2015 to add a voluntary ISO 9001:2008 module to the existing FSSC 22000 certification scheme, offering a combined FSSC 22000 and ISO 9001 certificate.
As from 1 March 2015 FSSC 22000-Q certification is available for organizations wishing to integrate food quality management into their certified scope
.

 

 

Regards,

 

Tony

 



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xylough

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Posted 10 June 2015 - 06:45 AM

Thank you all for your considered, expert opinions and scholarly research. I'm sure I can put all these perspectives and facts to good use. As it turns out, a new position offer I have accepted lands me in a facility that has already passed IFS Food recently. I will inherit the CAPA for the non-conformances without having participated in them :rofl2: , until the next audit. I appreciate this forum immensely, most especially the diligent work of the tireless ones who consistently contribute such stellar content.

Regards,

 

Xylough



Charles.C

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Posted 10 June 2015 - 06:47 AM

If you are interested in seeing the fascinating volumes/decades of discussions over this topic, can visit any ISO 9000 forums. The conclusion - still awaiting a consensus. :smile:

 

Typical result IMO - You decide which are your key documents and act accordingly. If you prefer to control every document in sight to the N'th degree and have sufficient Resources, best wishes.

 

PS @xylough - Congratulations on new position. Less sure about the IFS though. :smile:


Kind Regards,

 

Charles.C


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Charles.C

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Posted 10 June 2015 - 04:44 PM

Addendum

 

After a re-think I decided to modify my previous short post a little for “clarity”. And in the context of the OP.

 

AFAI can see, most of the Standards have ambiguous statements regarding “Document Control”. Most appear based on ISO 9001 whose scope/criteria for “documents to be controlled” is detailed here –

 

Attached File  document control.pdf   1.37MB   459 downloads

 

Pretty comprehensive IMO. :smile:

 

From Tony's post, only  the FSSC Standard seems to  specify which documents must be “controlled documents”. Namely All.

However both BRC and SQF’s respective Interpretation (I) and Guidance (G) seem to imply “All”. (The significance/power of  “I” from an audit POV is unclear to me although SQF’s “G” has been shown in forums threads to be "variable").

 

Regardless, from a practical audit POV, consider these  typical “document control”  terminologies -

 

Controlled copy - A controlled copy is a formal copy of the latest, correct issue of a document; an identified issue of a document to an individual or location of record.  The controlled copy is officially tracked, updated and destroyed to assure that it is current.

Uncontrolled copy - An informal copy of a document for which no attempt is made to update it after distribution; the document is marked “Uncontrolled” and the user is responsible for determining if the document is active prior to use.

 

From the above defs,  this quote maybe summarises the (practical) difference between controlled/uncontrolled documents –

 

In my opinion, there is no real difference between controlled and uncontrolled documents.

With both, you must be able to prove/verify revision level upon audit. The base line is how do you know you're using the right document, and you need to be using the most current version at all times because most of what you do affects quality. So whether you call the document controlled or uncontrolled you're still stuck making sure that you have the correct revision before use.

The difference is how good is your distribution system and how trustworthy is it? This is the real difference, in my opinion, between controlled and uncontrolled documents. One you can trust because it is monitored and controlled, the other you can't so you must verify before use.

 

 

Implying, to my understanding,  for a < 100% electronic system, one may as well classify all direct  printed copies from the master document as “controlled copies”, eg via coloured paper/stamps/ whatever.


Kind Regards,

 

Charles.C


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