Employer Warning Notice a Controlled Document?

J

jmariscal90

#1
so I am pretty new to ISO and I believe I know the answer but would like to get some more info on this.

would an employee warning notice need to be controlled, along with rev. number. approval date, etc? I don't think it does since it does not fall under the lines of req records:
Management Review Meetings – minutes (5.6.1)
Training records (6.2.2)
Product realization – evidence that requirements are fulfilled (7.1)
Sales activities where the customer requirements are reviewed, including enquiry & quotation, order receipt, order processing, order changes.(7.2.2)
Design and development – inputs, reviews, verification, validation, changes (7.3)
Supplier Evaluations (7.4.1)
re-validation of Special Processes (7.5.2) (processes where parameters are controlled e.g. temperature, rather than controlling the product)
Unique product ID records – (e.g. serial / batch number) if traceability is required (7.5.3)
Customer property – lost, damages or unsuitable for use (7.5.4)
Calibrations (7.6)
Internal Audits – findings and actions (8.2.2)
Product checks – throughout process and for final release, including ‘who’ (8.2.4)
Non-conformances (8.3)
Corrective actions (8.5.2)
Preventive actions (8.5.3)

nor documented procedures:
control of documents(4.2.3)
Control of records (4.2.4)
internal audit (8.2.2)
control of nonconforming product (8.3)
corrective action (8.5.2)
preventive action (8.5.3)


My understanding is the only documents that need to be controlled are those listed above. So my question is am I going in the right direction or did I completely miss it?
 

Attachments

Elsmar Forum Sponsor

normzone

Trusted Information Resource
#2
Re: Employer warning notice controlled doc?

You could make the case either way.

I tend to lean towards having a document number and revision control for all documents - if only because once you establish that there is some latitude for discretion, then it is often abused.

Document control is one of the easiest flaws for an auditor to detect, regardless of how good your system is. SOMEBODY is always using an obsolete revision they had on their hard drive or a printed copy in their desk.

In a disciplined environment you may choose differently, but I tend to be in Wild West scenarios where I'm still getting the players used to not shooting off their guns in the saloon.
 

Kronos147

Trusted Information Resource
#3
Re: Employer warning notice controlled doc?

Revisions are one of the ways we leave evidence of continual improvement.

At our company, Revisions are used to help Change Management. If we make a change and find it not effective, we can roll back to the prevision revision.

Food for thought.




One added; I used to discuss if a document should or shouldn't be controlled on a case by case basis, until I did a cost analysis of what those discussions cost the company. Everything gets controlled now.
 

Mark Meer

Trusted Information Resource
#4
Re: Employer warning notice controlled doc?

A few questions would help to decide:

1. What industry are you in? Higher-risk = higher degree of control is probably appropriate.

2. How important is the data to monitoring and improvement? Do you track data in a very specific form? If you just keep track of when, who and what, then a simple spreadsheet might be just fine.

3. Who uses the document? If only one or two people actually have authority to issue these warning notices, maybe it's unnecessary.

4. Have there been any problems/issues with this type of documentation in the past?

Unless your organization is a) in a high risk industry; b) the data form is important to monitoring; c) a lot of people use it; and/or d) there have been issues maintaining such records/data in the past, I'd say that such a document does not need to be heavily controlled.
 
J

jmariscal90

#5
Re: Employer warning notice controlled doc?

thank you all for the replies, this kind of raises another question to me... My company is a machine shop that focuses on the die casting of zinc and aluminum components. we are a small company and currently transitioning into the aerospace industry. So would it be better to control all documents that we have to further strengthen our QMS since we are going into a new field?
 

howste

Thaumaturge
Super Moderator
#6
Re: Employer warning notice controlled doc?

thank you all for the replies, this kind of raises another question to me... My company is a machine shop that focuses on the die casting of zinc and aluminum components. we are a small company and currently transitioning into the aerospace industry. So would it be better to control all documents that we have to further strengthen our QMS since we are going into a new field?
To me it really is easier to just control all documents. If there are any exceptions, then everybody thinks they should have exceptions for their documents too. If there's a business reason to have a document or form, then there's a good chance it should be controlled anyway.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Re: Employer warning notice controlled doc?

To me it really is easier to just control all documents.
I fully agree with the previous posters. The one reason I've seen some organizations/individuals failing to control documents outwith of the quality system is the erroneous notion that, by controlling such documents, they become fair game during an audit, such, for example, an ISO 9001 audit.

In my view, an employer warning notice form (with the possible exception of an unusual/a rare context) would not be part of the QMS, thus should not be under the scope of an ISO 9001 audit.

This unfounded fear sometimes makes people not control/proceduralize aspects out of the QMS.

Good, knowledgeable, competent auditors understand the need to stick to the scope of the audit they are performing and not venture willy nilly beyond the envelope of the system they are expected to assess.
 
Thread starter Similar threads Forum Replies Date
N What is the best action for employee when employer is paying late? Career and Occupation Discussions 6
B End of Contract Notice to Employer Career and Occupation Discussions 11
hogheavenfarm Potential Employer Questions Reason for Leaving Career and Occupation Discussions 37
arios "Do's" and "Don'ts" of auditing a former employer General Auditing Discussions 12
Sidney Vianna Longevity at work - How long have you been working for your present employer? Career and Occupation Discussions 85
S Employer asking me to compromise on integrity Career and Occupation Discussions 46
T As an Employer, which Certification do you most recognize? Professional Certifications and Degrees 36
Crusader What/where is your "office"? Work out of home or an employer? Career and Occupation Discussions 33
C Present Employer Contact Details - May we contact your present employer? Career and Occupation Discussions 14
D Employer support of Elsmar Cove participation and activity Career and Occupation Discussions 48
D Strategies for Going In Blind - My employer is probably confused why I'm here Misc. Quality Assurance and Business Systems Related Topics 11
S Consulting on the side - What arrangements did you make with your employer? Consultants and Consulting 7
G Warning about Deltronic Gage Pins - The "Certification of Accuracy" document General Measurement Device and Calibration Topics 13
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
W IMDS - Help (Common Warning and Error Fixes) RoHS, REACH, ELV, IMDS and Restricted Substances 9
N IMDS Warning Polymer Material Two Substances RoHS, REACH, ELV, IMDS and Restricted Substances 7
9 EU Medical Device Manufacturer Warning Letters EU Medical Device Regulations 2
H Most Poorly Written FDA Warning Letter Ever? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J FDA 483 Warning Letter for use of Calipers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
W Medical Device Warning Lights Colors IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T FDA Form 483 Warning Letter - What next? US Food and Drug Administration (FDA) 7
S FDA Warning Letter Remediation - Enforcement Resolution & Remediation Process US Food and Drug Administration (FDA) 3
L Warning Letter adressed to owner/operator or facility? US Food and Drug Administration (FDA) 1
AnaMariaVR2 Agila Specialties Private Limited Warning Letter US Food and Drug Administration (FDA) 0
AnaMariaVR2 Warning ? Don?t Confuse ?Made In USA? And ?Inspected By FDA? With Patriotism US Food and Drug Administration (FDA) 3
S FDA Warning Letter on Medical Device Reporting Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
AnaMariaVR2 Gilead plant joins the FDA's "warning club" US Food and Drug Administration (FDA) 0
K Where you can read other companys' 483 FDA Warning Letters 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
AnaMariaVR2 Jubilant HollisterStier General Partnership [warning letter] US Food and Drug Administration (FDA) 1
M FDA Warning Letter - Product Association with Search Engine Results - Problems Ahead? US Food and Drug Administration (FDA) 10
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
AnaMariaVR2 Warning Letter to Fercy Personal Care Products - company kicked out FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
I IMDS Warning - Chromate Filming of Zinc Plating RoHS, REACH, ELV, IMDS and Restricted Substances 4
A FDA 483 Warning Letter Response Time Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
AnaMariaVR2 FDA writes up Warning Letter to British Homeopathic Drugmaker US Food and Drug Administration (FDA) 0
Y Siemens Healthcare - FDA Warning Letter Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
AnaMariaVR2 FDA Global Clampdown: 8 Warning Letters - Failing to Register Plants US Food and Drug Administration (FDA) 0
D Appropriate Statistical Methods to set up an Alert/Warning Limit Quality Assurance and Compliance Software Tools and Solutions 15
M MDR Rules Change Revealed in Warning Letter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
AnaMariaVR2 FDA issued Warning Letters to Beckman Coulter - 2011 US Food and Drug Administration (FDA) 1
Ajit Basrur FDA issues Warning Letters for misleading advertising of Lap-Band US Food and Drug Administration (FDA) 3
T FMEA Severity 9 &10 - Example of "with warning?" FMEA and Control Plans 6
A FDA Audit Documentation - Recently released FDA Warning Letter Qualification and Validation (including 21 CFR Part 11) 9
AnaMariaVR2 The Top 12 FDA 2011 Warning Letters Report US Food and Drug Administration (FDA) 7
AnaMariaVR2 FDA has issued three Warning Letters... US Food and Drug Administration (FDA) 13
C Cleanroom Class 8 (100,000) Particulate Control and Warning Limits Statistical Analysis Tools, Techniques and SPC 1
AnaMariaVR2 Anulex sees layoffs after FDA warning letter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A How long does it take US FDA to issue a Warning Letter Close Out Letter Other US Medical Device Regulations 2
AnaMariaVR2 Cordis CAPA Warning Letter US Food and Drug Administration (FDA) 0

Similar threads

Top Bottom