Controlling Records query that may cause some serious trouble for me

N

n_easy

#1
Hi All,

I'm just reading through the '4.2.4 Control of records' in conjunction with a book called, 'ISO 9000 Quality Systems Handbook' by David Hoyle.

What I am understanding from the book is that every record has to be controlled.

Now this may pose to be a problem for me, as we are a care company providing homecare in the UK. We have the following documents that are controled:
1. Care Plans - outlining instructions on what a care worker is to do with a client.
2. Charts - charts record information required by the care plan - items such as bowel movements, any episodes of aggression, medication administration charts etc.

Now the charts are completed on a monthly basis by care workers and brought back to the office at the end of the month. The Care Plans are static and stay at the client's home.

Simple question: Do these completed charts need to be controlled? We have so many client's and all of them have so many charts - do they all need to be controlled individually? The chart templates, which are unique to each client are controlled to log changes etc. However, do the completed charts i.e. records need to be controlled?

I cannot believe they need controlling - I would be sitting here all day long processing records to control if this is the case!

Just a little worried.

Thank you for your advice in advance.
 
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Stijloor

Staff member
Super Moderator
#2
Tell us if your organization is ISO 9001:2008 certified.
That will give the experts here some context to work from.
 

Jim Wynne

Staff member
Admin
#4
Hi All,

I'm just reading through the '4.2.4 Control of records' in conjunction with a book called, 'ISO 9000 Quality Systems Handbook' by David Hoyle.

What I am understanding from the book is that every record has to be controlled.

Now this may pose to be a problem for me, as we are a care company providing homecare in the UK. We have the following documents that are controled:
1. Care Plans - outlining instructions on what a care worker is to do with a client.
2. Charts - charts record information required by the care plan - items such as bowel movements, any episodes of aggression, medication administration charts etc.

Now the charts are completed on a monthly basis by care workers and brought back to the office at the end of the month. The Care Plans are static and stay at the client's home.

Simple question: Do these completed charts need to be controlled? We have so many client's and all of them have so many charts - do they all need to be controlled individually? The chart templates, which are unique to each client are controlled to log changes etc. However, do the completed charts i.e. records need to be controlled?

I cannot believe they need controlling - I would be sitting here all day long processing records to control if this is the case!

Just a little worried.

Thank you for your advice in advance.
The standard doesn't say that all records must be controlled. I can't speak for the book you reference, but I'd be surprised if it said that. The pertinent part of ISO 9001:2008 is: "Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled."

There are some clauses of the standard that specifically call for record-keeping, but beyond that, you need to look at the types of records you're concerned about and compare them to the requirement cited above.
 
#5
If you are dealing with patient records, there could very well be privacy issues to deal with (increases control by restricting access). Records may also be necessary to spot long-term changes in the patient. Because of these alone, I would say that you probably need some control over individual records. Most importantly, research on regulatory requirements for keeping health records.
 

Stijloor

Staff member
Super Moderator
#6
Hi All,

I'm just reading through the '4.2.4 Control of records' in conjunction with a book called, 'ISO 9000 Quality Systems Handbook' by David Hoyle.

What I am understanding from the book is that every record has to be controlled.

Now this may pose to be a problem for me, as we are a care company providing homecare in the UK. We have the following documents that are controled:
1. Care Plans - outlining instructions on what a care worker is to do with a client.
2. Charts - charts record information required by the care plan - items such as bowel movements, any episodes of aggression, medication administration charts etc.

Now the charts are completed on a monthly basis by care workers and brought back to the office at the end of the month. The Care Plans are static and stay at the client's home.

Simple question: Do these completed charts need to be controlled? We have so many client's and all of them have so many charts - do they all need to be controlled individually? The chart templates, which are unique to each client are controlled to log changes etc. However, do the completed charts i.e. records need to be controlled?

I cannot believe they need controlling - I would be sitting here all day long processing records to control if this is the case!

Just a little worried.

Thank you for your advice in advance.
My Colleagues provided excellent advice in the preceding posts.

I am now looking at David Hoyle's book (4th Edition).

Read carefully what he writes...;)

On pages 208 and 209, he lists the records required by ISO 9001.
Now, if any of the requirements in Section 7 of the Standard are excluded because of the nature of your business, some records obviously would not apply.

Next, you need to determine what records are essential for the effective operation of your management system.

Lastly, what records are required by any regulatory and/or statutory provisions that must apply to your organization?

I usually develop a simple spreadsheet of all records that are currently maintained (inventory) and then decide with the stakeholders which much be kept and which ones removed.

Hope this helps.
 

jelly1921

Quite Involved in Discussions
#7
Hi All,

I'm just reading through the '4.2.4 Control of records' in conjunction with a book called, 'ISO 9000 Quality Systems Handbook' by David Hoyle.

What I am understanding from the book is that every record has to be controlled.

Now this may pose to be a problem for me, as we are a care company providing homecare in the UK. We have the following documents that are controled:
1. Care Plans - outlining instructions on what a care worker is to do with a client.
2. Charts - charts record information required by the care plan - items such as bowel movements, any episodes of aggression, medication administration charts etc.

Now the charts are completed on a monthly basis by care workers and brought back to the office at the end of the month. The Care Plans are static and stay at the client's home.

Simple question: Do these completed charts need to be controlled? We have so many client's and all of them have so many charts - do they all need to be controlled individually? The chart templates, which are unique to each client are controlled to log changes etc. However, do the completed charts i.e. records need to be controlled?

I cannot believe they need controlling - I would be sitting here all day long processing records to control if this is the case!

Just a little worried.

Thank you for your advice in advance.
The record shall to be controlled! Because the chart provides evidence of conformity to requirements and of the effective operation.

To control a record means that:
1 you have a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.
You don't need to do all of above activities, but do necessary ones.

As you said, the workers bring the chart back to office at the end of mounth. That is the way you control to collect charts.

My suggestion is that you can take a photo for the charts by a digital camera, which takes you few seconds to get one photo, then you can store them into computer. Make sure each photo has unique name, something like client's name+location+date+worker's name etc.

2 you have to ensure that record remains legible, readily identifiable and retrievable. If you do what I said, it will become much easier for you meet the requirement.

Jelly
 
J

Jeff Frost

#8
I would assume that because you are in the UK that European Union Directive 95/46/EC (or equivalent) related to personal data may also be applicable to these medical records under Clause 7.5.4 of The Standard. Also the authors of the Standard dropped the reference to service about halfway through the Standard. Just remember that were the Standard says “product” you should replace it with the word “service” for you application of ISO 9001.
 
R

RMain

#9
The record shall to be controlled! Because the chart provides evidence of conformity to requirements and of the effective operation.

To control a record means that:
1 you have a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.
You don't need to do all of above activities, but do necessary ones.

As you said, the workers bring the chart back to office at the end of mounth. That is the way you control to collect charts.

My suggestion is that you can take a photo for the charts by a digital camera, which takes you few seconds to get one photo, then you can store them into computer. Make sure each photo has unique name, something like client's name+location+date+worker's name etc.

2 you have to ensure that record remains legible, readily identifiable and retrievable. If you do what I said, it will become much easier for you meet the requirement.

Jelly
Hi
I would suggest the Chart is Not the Record, but only a visual view of the data. The Data is the True Record. The Data is what is required to be identified, stored, protected, retrieved, retained and disposed of at the end of it's useful life. With the data you can create all kinds views, historical, trending etc..., charts would not always give you a flexible view of the data in it's long term.
My Two Cents
 
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